Study of a Treatment Driven by Early PET Response to a Treatment Not Monitored by Early PET in Patients With AA Stage 3-4 or 2B HL (AHL 2011)
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ClinicalTrials.gov Identifier: NCT01358747 |
Recruitment Status :
Completed
First Posted : May 24, 2011
Last Update Posted : May 21, 2014
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Tracking Information | ||||
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First Submitted Date ICMJE | May 11, 2011 | |||
First Posted Date ICMJE | May 24, 2011 | |||
Last Update Posted Date | May 21, 2014 | |||
Study Start Date ICMJE | May 2011 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures ICMJE |
Progression free survival [ Time Frame: 5 years ] Evaluate by PFS at 5 years the non-inferiority of a chemotherapy of a therapeutic strategy driven by PET with a ABVD conventional dose chemotherapy for patients reaching a negative PET after 2 cycles of BEACOPPesc, compared to a treatment not monitored by early PET delivering 6 cycles of BEACOPPesc.
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Original Primary Outcome Measures ICMJE |
Progression free survival PFS will be measured from date of randomization to date of first documented progression of the lymphoma in non-responding patients, relapse for CR patients or death from any cause without progression, whichever occurs first. Patients alive and free of progression or who are lost to follow-up will be censored at their last follow-up date.
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Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Study of a Treatment Driven by Early PET Response to a Treatment Not Monitored by Early PET in Patients With AA Stage 3-4 or 2B HL | |||
Official Title ICMJE | Randomized Phase III Study of a Treatment Driven by Early PET Response Compared to a Treatment Not Monitored by Early PET in Patients With Ann Arbor Stage III-IV or High Risk IIB Hodgkin Lymphoma | |||
Brief Summary | All study treatments have proven efficacy in the treatment in Hodgkin lymphoma (HL). It is hoped that patients will achieve a good response to both induction therapies consisting either of 4 cycles of BEACOPPesc (Bleomycin, Etoposide, Doxorubicin, Cyclophosphamide, Vincristine, Procarbazine, and Prednisone) or 2 cycles of BEACOPPesc plus 2 cycles of ABVD (Adriamycine, Bléomycine, Vinblastine, Décarbazine). The use of F-FDG Position Emission Tomography performed after 2 cycles of chemotherapy (PET2) in the experimental arm will help to stratify patients in order to restrict the BEACOPPesc therapy continuation to those patients who achieved only a partial response after 2 BEACOPPesc regimen and to allow a conventional dose ABVD chemotherapy strategy for PET2 negative patients. For all patients included in the trial the achievement of a good response to induction treatment will be checked after four cycles of induction treatment including a centrally reviewed PET assessment Patients will be randomized after verification of eligibility and before the start of the protocol treatment.Patients will be randomly assigned to the standard treatment arm not monitored by early PET, or the experimental treatment arm driven by the PET2 result. |
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment |
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Condition ICMJE | Hodgkin's Lymphoma | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | Not Provided | |||
Original Enrollment ICMJE | Not Provided | |||
Study Completion Date ICMJE | Not Provided | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
IIB with mediastinum/thorax ≥0.33 or extra nodal localization III IV
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 16 Years to 60 Years (Child, Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium, France | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01358747 | |||
Other Study ID Numbers ICMJE | Casasnovas PHRC N 2010 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Centre Hospitalier Universitaire Dijon | |||
Original Responsible Party | Not Provided | |||
Current Study Sponsor ICMJE | Centre Hospitalier Universitaire Dijon | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | The Lymphoma Study Association | |||
Investigators ICMJE |
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PRS Account | Centre Hospitalier Universitaire Dijon | |||
Verification Date | January 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |