The 55th Annual Meeting of the American Society of Hematology (ASH) will be held Saturday, December 7, through Tuesday, December 10, 2013, in New Orleans, Louisiana. The goal of the ASH annual meeting is to present the best new scientific research in all areas of hematology.
All abstract submissions must be made electronically through ASH's online abstract submission system. The site opens on June 6, and the abstract submission deadline is Thursday, August 8, 2013, 11:59 p.m. (PDT).
To submit an abstract, the following criteria must be met:
- At least one of the authors must be an ASH member who has paid the current membership dues.
- If none of the abstract authors is an ASH member, the abstract must be sponsored by a current ASH member. ASH members are urged to use their best judgment in restricting sponsorship to a reasonable number of abstracts, keeping in mind that they are endorsing the authenticity and quality of each abstract that they sponsor.
- Research and/or studies must fit into one of the ASH 2013 Abstract Review Categories.
Any of the following criteria will make an abstract ineligible for presentation at the ASH annual meeting:
- Data are publicly available via major search engines (such as PubMed, Google Scholar, etc.);
- Data are accepted for publication before the abstract submission closing date;
- Data have been or are to be presented at a meeting of 1,000 or more participants before the ASH annual meeting;
- Data are to be presented at an ASH Friday Satellite Symposium.
The author may request special consideration (see section below) if the abstract contains significant new information.
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Responsibilities of the Presenting Author
- The first author listed for each abstract serves as the presenting author and as the primary contact for all correspondence regarding the abstract, unless otherwise specified under the “Contact Information” section of the online abstract submission system.
- The presenting author must be one of the co-authors listed on the submitted abstract.
- The presenting author is responsible for the following:
- Ensuring that all authors have read the abstract and agreed to be co-authors. Failure to get approval from all authors will result in rejection of the abstract.
- Notifying all co-authors of any additions, deletions, and changes to the program, as may be communicated by ASH.
- Obtaining all of the conflict-of-interest disclosure and copyright transfer information from co-authors.
- Forwarding all correspondence to all co-authors, including ASH policies and guidelines and the Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support for Continuing Medical Education (CME).
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Author's Consent and Waiver of Claims
- Each abstract author agrees and certifies that he or she:
- has read all of the rules and agrees to be bound by them,
- is responsible for submission of the abstract in accordance with the rules, and
- waives any and all claims against ASH and any reviewer arising out of or relating to the abstract submission and review process, including but not limited to peer review and the grading of abstracts.
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- The abstract must address scientific questions, detail clinical observations, or contain primary scientific data.
- Abstracts submitted to ASH are embargoed from the time of submission. This means that the data in the abstract cannot be submitted to other meetings and/or publishers once submitted for the ASH annual meeting. Read the Embargo Policy section of the Call Abstracts for more information.
- All research and studies reported in submitted abstracts that involve human and animal subjects must comply with the guiding principles for experimental procedures found in the Declaration of Helsinki of the World Medical Association.
- Data from the long-term follow-up of previously presented clinical trials may be submitted only if significant new information can be shown. In this case, please request Special Consideration.
- Interim analysis of a prospective randomized clinical trial will be considered only if it is performed as planned in the original protocol and is statistically valid. If your abstract involves interim analysis, explain the details of your study in the text box provided under the submission information section online.
- There is a $60 nonrefundable handling fee for submitting an abstract. Payment must be made by credit card; Visa, MasterCard, and American Express are accepted. Purchase orders and checks will not be accepted. The abstract submission fee does not include registration for the annual meeting; therefore, all authors planning to attend the ASH annual meeting must register for the meeting.
- No revisions can be made after the abstract submission deadline.
- Abstracts generally may not be withdrawn once submitted. If you prefer that your abstract be withdrawn if not accepted for any presentation at the ASH annual meeting, you must indicate so during online submission.
- The presentation at the annual meeting must reflect the submitted abstract. In particular, the abstract title, authorship, and scientific content of the presentation at the annual meeting must match the submitted abstract, although updates on results may be added.
- Abstracts should be written in clear and concise English, so that reviewers are able to focus solely on the scientific merits of the submission. We encourage non-English-speaking authors to have their abstracts checked for grammar and spelling prior to submission.
- It is assumed that the presenting author will have adequate command of English to present and to respond to questions.
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Preferred Presentation Format
During submission, submitters must choose the formats in which they would be willing to present/publish their abstract. These choices must be made at the time of submission and cannot be changed after the review committee has reached its decision.
- First, authors select whether they prefer oral or poster presentation. Abstracts noted with a preference for poster presentation will NOT be considered for oral presentation, regardless of score.
- Second, in the event that an abstract is not chosen for oral presentation, it can still be chosen for poster presentation. Authors who state a preference for oral presentation must decide whether they would accept poster presentation. Authors may either present a poster or request that the abstract be immediately withdrawn. (Please note that declining to have your abstract considered for poster presentation does not improve its chances of being accepted as an oral presentation. This option should be selected primarily by authors who would not be willing to present a poster.)
- Finally, in the event the abstract is NOT selected for presentation, all submitting authors must decide whether they want their abstract to be published in the online-only issue of Blood (which is part of the permanent Blood archive), or whether the abstract should be withdrawn completely and not published either online or in print.
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Requesting Special Consideration
- Special consideration may be requested by explaining the special circumstances in the text box provided during the online abstract submission process. We encourage authors to request special consideration if the abstract is a significant extension of previously published work or if the author has a reason to believe that the data will be published, either online or in print, or presented in any form prior to the ASH annual meeting. The information provided will be carefully evaluated by the reviewers.
- Failure of authors to request special consideration for an abstract, including content that has been published or presented at a meeting of 1,000 or more participants or in a press release published before the ASH annual meeting, will result in exclusion from the program.
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Abstract Review and Selection Process
- After the submission deadline, all completed and eligible abstracts will be made available to the ASH Abstract reviewers for blinded review and scoring, and final decisions will be made by the Program Committee in late September 2013.
- Abstracts will be evaluated and scored solely on their scientific merits.
- Incomplete abstracts will not be reviewed.
- The same study must not be submitted as multiple abstracts. Abstracts that are simply different versions of a single study will be rejected.
- Abstracts will be peer reviewed according to the subject categories. Authors must indicate during online submission the appropriate review category (one only). You will be able to use the list of abstract review categories, which provides detailed descriptions of each category, to assist you in selecting the correct abstract classification. Please read through all of the categories and select the category most closely associated with your abstract. All category selections will be final. There will be NO re-classification of abstracts after the abstract submission site has been closed.
- All abstracts submitted will be considered eligible for one presentation: either plenary, oral (simultaneous session), or poster.
- The Plenary Session features the top six abstracts. These are formal oral presentations, each followed by a brief discussion. An ASH member selected by the Program Committee will give a brief introduction to the abstract.
- Oral (simultaneous) Sessions are formal oral presentations followed by a brief discussion.
- Poster Sessions allow the viewing of a poster illustration of the abstract. Authors are expected to post and remove posters at designated times and to be at their posters to answer questions during the time designated for poster presentations. The author's attendance during poster presentation time will be monitored.
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- Notification regarding acceptance or rejection of abstracts will be sent to the presenting author in mid-October 2013 by e-mail; consequently, an accurate e-mail address is critical. If your abstract is accepted, the e-mail will specify whether it is accepted as plenary, oral, or poster presentation or whether it has been selected to be published online only. If you have not received an e-mail notification by October 10, 2012, contact ASHabstracts@hematology.org. Rejection notifications will also be sent at that time.
- To ensure that you are able to receive e-mail correspondence from ASH, please make sure that your e-mail software can receive mail from the confex.com and hematology.org domains. You should add firstname.lastname@example.org and ASHAbstracts@hematology.org to your address book. If after completing your submission you don't receive a confirmation e-mail from the abstract system, you must contact your system administrator and make sure that both the confex.com and hematology.org domains are added to your e-mail address whitelist.
- The decision of the ASH Program Committee regarding acceptance and presentation of abstracts is final.
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- Once an abstract is accepted, a written request to withdraw must be submitted no later than October 11, 2013, to ASHabstracts@hematology.org if the first author decides to withdraw the abstract for any reason. Abstract withdrawal requests received after the deadline will be considered on a case-by-case basis.
- ASH reserves the right to withdraw abstracts that are in violation of the Society’s policies and guidelines, such as those that have been previously published or presented, have been deemed scientifically unsound, or have been found to include inaccurate data, etc.
- If you indicated at submission that you wish to withdraw your abstract if it is not accepted for either oral or poster presentation, your abstract will be automatically withdrawn, and you will be notified; you do not need to request withdrawal.
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Publication in the Abstracts Issue of Blood, the Journal of the American Society of Hematology
- All abstracts accepted for presentation (plenary, oral, or poster) at the ASH annual meeting are published in a special online-only issue of Blood, ASH's official journal, on the Blood Abstracts website http://bloodjournal.hematologylibrary.org/site/misc/ASH_Meeting_Abstracts_Info.xhtml.
- Abstracts not selected for presentation will also be published online-only on the Blood Abstracts website http://bloodjournal.hematologylibrary.org/site/misc/ASH_Meeting_Abstracts_Info.xhtml. If an author does not want the abstract published if it is not accepted for presentation, he/she must indicate that during submission.
- ASH reserves the right not to publish abstracts that do not fit into any of the review categories, abstracts that inappropriately promote commerical interests, abstracts that are judged unethical, poorly written, or scientifically unsound, or abstracts considered inappropriate for publication for other reasons as determined by the Program Committee.
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Late Breaking Abstracts
- Recognizing that the results of some top-quality research may not be available by the general abstract submission deadline, the ASH Program Committee offers an option for late-breaking abstracts. The late-breaking abstracts submission site will open October 22 and will close October 29, 2013. Late-breaking abstracts will undergo regular peer-review evaluation. Only six abstracts will be accepted and presented in the Late-Breaking Abstractss sessions on Tuesday, December 10. The accepted abstracts will be published online-only at http://bloodjournal.hematologylibrary.org/site/misc/ASH_Meeting_Abstracts_Info.xhtml. Late-breaking abstracts not accepted for presentation will not be published in any form.
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Abstract Submission Policies
Conflict of Interest Disclosure Policy
- ASH is committed to ensuring the integrity of its scientific, educational, and research programs. The ASH Conflict-of-Interest Policy requires disclosure of any financial or other interest that might be construed as resulting in an actual, potential, or apparent conflict.
- ASH abides by rules formulated by the Accreditation Council for Continuing Medical Education (ACCME) that require that you disclose any relevant financial relationship you or your spouse/partner have had within the past 24 months. For this purpose, “relevant financial relationships” are those from which you have received or may receive financial benefit and which are related to the CME content.
- As a continuing medical education (CME) provider accredited by the ACCME, ASH must ensure balance, independence, objectivity, and scientific rigor in all presentations at the ASH annual meeting.
- By completing this section of the online abstract submission, you agree that you have read the ASH Conflict-of-Interest Policy and that you understand and support its intent.
- This policy is not intended to prevent a presentation; it is merely intended to openly identify potential conflicts so that audience members may form their own judgments about the presentation with a full disclosure of the facts.
- Abstracts will not be considered for the program without completion of disclosure information for all of the authors.
Author Responsibility Regarding Conflict of Interest Disclosure
- The presenting author is responsible for obtaining disclosure information from all co-authors.
- All authors and co-authors are required to provide any relevant information concerning personal or professional circumstances and relationships that might reasonably be expected to affect the author’s view on the presentation.
- This includes relationships with pharmaceutical companies, biomedical device manufacturers, or other companies whose products or services are related to the subject matter of the presentation topic. If no relevant relationships exist, this must be stated as well.
When to Disclose
Please disclose any relationships or circumstances that might affect or appear to affect the research presented. These relationships include you or any individual with whom you directly share income.
What to Disclose
You must disclose the relationship and state the name of the company for each of the following areas in which you maintain a relationship. Exact dollar amounts are not necessary. You will have the option to note that there is no information to disclose or to provide disclosure information pertinent to the abstract. Disclosed information pertinent to the abstract may include the following areas:
- Ownership interests (including stock options) in a start-up company, the stock of which is not publicly traded
- Ownership interest (including stock options, but excluding indirect investments through mutual funds and the like) in a publicly traded company
- Research funding
- Honoraria directly received from an entity
- Patents and royalties
- Paid expert testimony
- Membership on an entity’s board of directors, speakers bureau, or its advisory committees
- Any other financial relationship
You will be required to note whether your presentation will include discussion of off-label use of products. If so, you must provide a brief explanation.
During the disclosure submission process, you will also be required to indicate your compliance with the following:
- If you are providing recommendations involving clinical medicine, these recommendations will be based on evidence that is accepted within the profession of medicine as adequate justification for their indication and contraindications in the care of patients. All scientific research referred to in support of a patient-care recommendation will conform to generally accepted standards of experimental design, data collection, and analysis.
- The content of the information with which you are involved will promote quality in health care or advances in science and will not promote a specific proprietary or commercial interest. Content for this publication will be well-balanced and unbiased.
- If you have been trained or utilized by a commercial entity or its agents as a speaker (e.g., participation in a speaker’s bureau) for any commercial interest, the promotional aspects of that work must not be included in the presentation in any way.
- Abstracts submitted to the ASH annual meeting are embargoed from the time of submission.
- For the research to be eligible for presentation at the ASH annual meeting, information contained in the abstract, as well as additional data and information to be presented about the research at the annual meeting, may not be made public before the abstract has been published/presented at the ASH annual meeting.
- Prior to the embargo being lifted, the first author, co-authors, and sponsor of the abstract must not:
- Publish the information or provide it to others who may publish it.
- Release the research/study to news media, or
- Use the information for trading in the securities of any issuer, or provide it to others who may use it for securities-trading purposes.
- An exception may be granted in cases in which the Securities and Exchange Commission (SEC) requires a press release to comply with security laws. ASH will consider such requests on an ad hoc basis. More information on requesting such an exception can be found here.
- If the Embargo Policy is violated, the abstract may be withdrawn by ASH from presentation at the annual meeting and from publicationonline.
- More detailed information about the Society’s Embargo Policy is located here. Please contact ASH Communications Manager Andrea Slesinski at email@example.com or 202-552-4927 with any questions.
ASH Statement on Commercial Interest Presenters
The primary purpose of the ASH Continuing Medical Education Program is to advance the professional development of our learners in order to increase knowledge and improve the diagnosis and treatment of patients. In order to maintain the flow of the most current information to our learners and to serve the public interest, the content of ASH CME may include information planned, presented, or authored by employees of commercial interests. ASH is committed to the integrity of the science presented at its CME activities and employs a rigorous peer review process to ensure that integrity. The content of presentations by commercial interest employees must focus on basic science and not on the product or on the commercial aspects of the discovery. In addition, the format of the presentation must permit full discussion of the therapeutic benefits and risks of the discovery. ASH maintains control of all content and plans all of its activities in compliance with the ACCME Standards for Commercial Support.
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How to Submit an Abstract
The abstracts submission site is open June 6- August 8, 2013
All abstracts must be submitted by August 8, 2013, at 11:59 p.m., Pacific Daylight Time. Submissions that are incomplete by the deadline will be rejected.
- Abstracts must be submitted online through the official online abstract submission system. E-mails and word processing files not submitted through the site will not be accepted.
- There is a $60 non-refundable handling fee for submitting an abstract. Payment must be made by credit card; Visa, MasterCard, and American Express are accepted. Purchase orders and checks will not be accepted. The abstract submission fee does not include registration for the annual meeting; therefore, all authors planning to attend the ASH annual meeting must register for the meeting.
- Electronic submission works optimally with Microsoft Internet Explorer 7+, Mozilla Firefox 3.0+ and Safari or MAC OS 10.4+. Netscape Navigator 7.7+ is supported, but its use is discouraged, since not all features are available. The online abstract submission system will provide links so that you can download free browser software.
- If this is the first time that you are submitting an abstract for the ASH annual meeting, please be sure to check the box that indicates this during submission.
- Once you have submitted the title page information, a draft of your abstract will be saved, and you will be able to return to edit and update it at any time until August 8, 2013, at 11:59 p.m. PDT. You will receive an email providing a link to your submission.
- Abstracts cannot be submitted and will not be reviewed without proper payment and completion of the "Submission Information" and "Disclosure" sections of the online abstract submission program.
- Any technical questions regarding the submission process should be directed to firstname.lastname@example.org.
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Preparing an Abstract for Submission
- Your name, degree, institution, address, phone number, and e-mail address must be provided. As the corresponding author, you will receive all future correspondence from ASH.
- The corresponding author should be the first author (presenter) of the abstract, unless otherwise noted during submission.
- If none of the abstract authors is an ASH member, the program will ask you to provide the name of the ASH member who is sponsoring the abstract.
- Names of co-authors and institutions must be provided. The program will automatically place an asterisk (*) after the name of each non-member author. Changes will not be made to the spelling of authors’ names after the submission deadline; please proof your co-authors’ names carefully.
- All authors must assign copyright of the abstract to ASH, unless one of the authors is a U.S. Federal employee (in such case, ASH does not hold copyright).
- The abstract title should be brief and clearly indicate the nature of the abstract.
- The abstract title must be in title case. Capitalize all nouns, pronouns, adjectives, verbs, adverbs, and subordinate conjunctions (i.e., as, because, although). Except for the first word of the title, lowercase all articles, coordinate conjunctions (i.e., and, or, nor), and prepositions, regardless of length. Also, lowercase “to” when used as an infinitive.
- Additionally, keep letters lowercase if the lowercase letters have a specific meaning, such as pH or NaCl.
- Do not put a period at the end of the title.
- For example: Somatic Mutations in Schinzel-Giedion Syndrome Gene SETBP1 Determine Progression in Myeloid Malignancies
Use of Product Names
- Non-proprietary (generic/scientific) names should be used and should be lowercase.
- If necessary, you may include a proprietary name in parentheses directly following the generic name after its first mention in the body of the abstract; the first letter of the name of a proprietary drug should be capitalized. ASH reserves the right to replace proprietary names with generic names to adhere to this policy.
Use standard abbreviations. Place abbreviations in parentheses immediately after the first mention of a term or phrase; the abbreviation can then be used throughout the abstract.
Abstract Body, Tables, and Figures
- Abstracts submitted for the ASH annual meeting are published in a special online-only November 2013 issue of Blood, the Journal of the American Society of Hematology. Abstracts will be typeset from the text submitted by the author without copyediting changes. It is the responsibility of the author to proofread the abstract carefully.
- The entire body of the abstract, including text and tables, must not exceed 3,800 characters. Spaces are not included in this number; title, authors’ names, and affiliations are counted separately. Figures are not included in the character count.
- The abstract may be structured (i.e., abstracts divided into sections using terms such as Introduction, Methods, Results, Conclusions, etc.) or unstructured.
- Do not use bold type or underline formatting. Italic type is acceptable.
- Text may be in multiple paragraphs. Do not indent the first line of paragraphs.
- Special Greek and mathematical symbols are available in a character map within the submission system.
- Use the numerals to indicate numbers, except when beginning sentences.
- Simple tables and graphs may be included. The outline abstract submission system provides step-by-step instructions on inserting tables and graphs in the preferred HTML format.
- Any references should be noted as citations within the text and not as footnotes at the end.
Selection of Abstract Review Catergory
- Please refer to the list of this year's abstract review categories, which provides detailed descriptions of each category, to assist you in selecting the correct abstract classification.
- Be sure to select from the review category that best describes your abstracts. Note that the abstract will be reviewed in the category you selected; there is no re-classification once submission has closed.
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ASH Supports four types of awards for high-scoring abstracts submitted by hematologist-in-training.
How to be considered for an Abstract Achievement Award:
- All hematologists-in-training, who are both first author and presenter of the abstract, are automatically considered for an Abstract Achievement Award. Therefore, you must first identify as a hematologist–in-training and then select the appropriate training category (undergraduate student, medical student, graduate student, resident physician, or post-doctoral fellow) in the online abstract submission system.
- As a hematologist-in-training, you are required to submit a letter from the senior investigator overseeing your research confirming your status as a hematologist-in-training.
- Your letter must be typed on your institution’s letterhead, signed by the senior investigator, saved in PDF format, and uploaded to the online abstract submission system.
- Please include the following items in your letter:
- Author name (this is the hematologist-in-training who is the presenting/contact author)
- Confirmation of your status as a hematologist-in-training
All hematologist-in-training authors must upload the required letter into the program in order to complete the abstract submission. The deadline for receipt of the hematologist-in-training letter is, therefore, August 8, 2013. There will be no exceptions.
Abstract Achievement Awards
- Undergraduate students, medical students, graduate students, resident physicians, and post-doctoral (MD or PhD) fellows who are both first author and presenter of the abstract are eligible for an ASH Abstract Achievement Award (formerly Travel Awards).
- ASH Abstract Achievement Awards are merit-based awards in the amount of $500 offered to trainees with high-scoring annual meeting abstracts.
- Abstract Achievement Award recipients will be notified if they will receive an award by late October 2013. You must attend the meeting and present your abstract to receive your award.
Outstanding Abstract Achievement Awards
- ASH Outstanding Abstract Achievement Awards (formerly Merit Awards) are provided to abstract presenters who are the first authors of the highest scoring abstracts in their categories. There is one award for each of the following categories: undergraduate student, medical student, graduate student, resident physician, and post-doctoral fellow (MD or PhD).
- Outstanding Abstract Achievement Award winners receive a $500 honorarium plus annual meeting travel reimbursement (coach airfare and two nights' hotel accommodations).
- Abstract Achievement Award recipients will be notified if they will receive an award by late October 2013. You must attend the meeting and present your abstract to receive your award.
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Special ASH Outstanding Abstract Achievement Awards
Mary Rodes Gibson Memorial Award in Hemostasis & Thrombosis
- This annual award is given to a trainee (undergraduate student, medical student, graduate student, resident physician, or post-doctoral [MD or PhD] fellow) who is the first author and presenter of the highest scoring abstract submitted in the field of hemostasis and thrombosis.
- The recipient receives a $5,000 grant and a $1,000 allowance for travel and expenses to the ASH annual meeting.
- This annual award is made possible by the Mary Rodes Gibson Hemostasis-Thrombosis Foundation to continue the legacy of Mary Rodes Gibson, who suffered from severe, type 3 von Willebrand disease.
Minority Graduate Student Abstract Achievement Award
- This award recognizes minority PhD students at U.S. or Canadian institutions whose abstracts have been accepted for oral or poster presentation at the ASH annual meeting.
- Minority Graduate Student Abstract Achievement Award recipients receive a $1,500 grant to attend the ASH annual meeting.
- Minority Graduate Student Abstract Achievement Award applicants will be notified as to whether or not they received an award by late October 2013. Please contact ASH Headquarters at email@example.com if you have not heard about the status of your award by November 1, 2013. You must attend the meeting and present your abstract to receive your award.
Additional requirements to apply for the Minority Graduate Student Abstract Achievement Award:
- To apply, applicants must first submit an abstract as a hematologist-in-training to the ASH annual meeting through the online abstract submission system by August 8, 2013.
- Applicants must also submit a program application to firstname.lastname@example.org by 11:59 PM PST on August 9, 2013.
- For complete eligibility requirements and to download the program application, please visit www.hematology.org/Awards.
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Completion of all required disclosure information in the online abstract submission system serves as an agreement and is accepted in lieu of a faxed signature. It certifies the ASH abstract submitter's understanding of the rules for participation contained in the online abstract submission program and affirms that:
- All authors approve of submitting this work for presentation and publication;
- The author(s) transfer(s) all copyright ownership of the named abstract to the American Society of Hematology (except when one or more authors are U.S. Government employees);
- All authors have read the ASH Abstract Conflict-of-Interest Policy and have acted in accordance with that policy;
- The author(s) agree(s) to materially confine the presentation to information in the abstract, if accepted for presentation. If an author has more than one abstract accepted, each presentation will be materially confined to the information in the abstract selected for the specific session;
- The presenting author will be available to present the abstract if selected for the program. The author(s) will immediately notify ASH if the presenting author must be changed; and
- The data in the late-breaking abstract are not publicly available via major search engines; have not been accepted for publication before the abstract submission closing date; have not been nor are to be presented at a meeting of 1,000 or more participants before the ASH annual meeting; and are not to be presented at an ASH Friday Satellite Symposium.
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A sample abstract is provided for your reference below. Note that the title, authors, and institutions are entered in separate fields in the submission form, not in the abstract body, as they are not included in the character count.
An Intergroup Randomised Trial of Rituximab Versus a Watch and Wait Strategy In Patients with Stage II, III, IV, Asymptomatic, Non-Bulky Follicular Lymphoma (Grades 1, 2 and 3a). A Preliminary Analysis, Kirit M. Ardeshna, MD*,1, Wendi Qian*,2, Paul Smith*,3, June Warden,*,3, Lindsay Stevens*,3, Christopher FE Pocock, MD, PhD*,4, Fiona Miall, MD*,5, David Cunningham, MD*,6, John Davies, MD*,7, Jan Walewski8, A. Burhan Ferhanoglu, MD9, Ken Bradstock, MB, PhD10 and David C. Linch, MD, FMedSci*,111Haematology, University College London Hospitals, London, United Kingdom, 2 MRC Clinic, London, England, 3 Cancer Research UK & UCL Cancer Trials Centre, London, United Kingdom, 4 Haematology, Kent and Cantebury Hospital, Cantebury, United Kingdom, 5 Leicester Royal Infirmary, Leicester, United Kingdom, 6 Royal Marsden Hospital, London, United Kingdom, 7 Haematology, Western General Hospital, Edinburgh, 8 Department of Lymphoproliferative Diseases, Maria Sklodowska-Curie Memorial Institute and Cancer Center, Warsaw, Poland, 9 Nispetiye Mahallesi, Istanbul, Turkey, 10 Haematology, Westmead Hospital, Sydney, Australia, 11 Haematology, University College London, London, United Kingdom
Patients with asymptomatic, advanced stage, follicular lymphoma have shown no benefit of immediate chemotherapy when compared with a watchful-waiting approach, whereby chemotherapy is deferred until disease progression. Deferring chemotherapy may spare the patient the side effects of the chemotherapy in the short term and historically this has been the preferred approach. With the advent of rituximab and its relatively favourable side effect profile we designed this study to compare a watchful waiting approach with immediate treatment with rituximab.
Adult patients with asymptomatic stage 2, 3 or 4 follicular lymphoma (grades 1–2 & 3a) and adequate bone marrow reserve were randomly assigned with a ratio 1:1:1 to watchful waiting (arm A) or rituximab 375mg/m2 weekly for 4 weeks (arm B) or rituximab 375mg/m2 weekly for 4 weeks followed by rituximab maintenance every 2 months for 2 years (starting at month 3 until month 25)(arm C). The primary endpoints were a) time to initiation of new therapy (chemotherapy or radiotherapy) and b) effect on quality of life. The study was designed to detect an improvement in the median time to initiation of therapy in each of the rituximab arms of 18 months (from 30 months to 48 months) with 2.5% significance level and 90% power. A total of 230 events were required and 600 patients were planned. In September 2007, a decision was made to discontinue arm B as evidence of the efficacy of maintenance rituximab became clear. With the two arms comparison, using a significance level of 5%, a total of 360 patients in Arm A and Arm C were planned.
Between September 2004 and May 2009 462 patients were randomised (186 Arm A, 84 Arm B, and 192 Arm C). 95% of patients had low tumour burden (GELF criteria) the other 5% had raised LDH but fulfilled the remaining GELF criteria. 98% were entered into the study within 4 months of diagnostic biopsy. Median age 60yr (range27-87). 54% female. ECOG performance status 0=91% & 1=9%. Grade 1–2=89%. Stage 2(21%), stage 3(40%), stage 4 (39%). 42% had bone marrow involvement. FLIPI score: 0=9%, 1=26%, 2=41%, 3=22%, 4=2%.
In March 2010 the Data Monitoring committee concluded that the data regarding time to initiation of new therapy was mature and recommended full analysis of data to be performed and presented in the knowledge that rituximab maintenance was still ongoing in 20 patients. To date 45 SAEs have been reported (Arms A=14, B=6, C=25), 14 SAE were considered possibly, probably or definitely related to the study drug (Arm B=4, C=10). 5 allergic reactions (two grade 3), 6 infections, 3 episodes of grade 4 neutropenia. Responses were assessed at month 7, 13 and 25. CT was compulsory at months 7 and 25. Bone marrow was only required if CR on clinical and CT criteria. An interim analysis was performed on 9 Feb 2010. At month 7: Arm A: spontaneous remission was seen in 3%, PR=6%, NC (no change) =74%, PD=17%. Arm B: CR+CRu=45%, PR=33%, NC=19%, PD=3%. Arm C: CR+CRu=49%, PR=36%, NC=11%, PD=3%. At the time of the interim analysis 93 (20%) patients had initiated new treatment. Of these 93 patients 84 (90%) had clinically reported progression. New treatment was chemotherapy in 78 (84%), radiotherapy in 10 (11%), rituximab monotherapy in 2 (2%), surgery in 1(1%),currently not known in 2 (2%). The estimated median time to initiation of new therapy in arm A was 33 months, similar to our previous trial of watchful waiting (Ardeshna et al Lancet 2003). The time to initiation of new therapy was significantly longer in the rituximab arms (fig 1, p value of log-rank test <0.001 for each of rituximab arms vs arm A) and the median time was not reached at 4 years. Not all patients who were reported to have clinically progressed (n=142) warranted initiation of therapy (n=84). There were again significant differences in progression-free survival between the observation and rituximab arms (fig 2, p value of log-rank test <0.001 for each of rituximab arms vs arm A). 98% of patients remain alive and there was no different in overall survival between the 3 arms (p value >0.5). These data indicate that initial treatment with rituximab significantly delays the need for new therapy and this finding may change the management of patients with newly diagnosed asymptomatic follicular lymphoma.
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