Avastin (Bevacizumab) Plus Adriamycin, Bleomycin, Vinblastine and Dacarbazine (ABVD) for Advanced Stage Hodgkin Lymphoma
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|ClinicalTrials.gov Identifier: NCT00722865|
Recruitment Status : Terminated (slow enrollment)
First Posted : July 28, 2008
Results First Posted : April 28, 2017
Last Update Posted : October 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hodgkin Lymphoma||Drug: Avastin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Avastin (Bevacizumab) in Combination With ABVD for the Treatment of Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma|
|Study Start Date :||September 2008|
|Primary Completion Date :||November 2015|
|Study Completion Date :||November 2015|
Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles.
Other Name: Bevacizumab
- Failure-free Survival [ Time Frame: 2 years and median follow-up of 18 months ]Failure-free survival: the absence of relapse, non-relapse mortality or addition of another systemic therapy
- Overall Response Rate Using the Modified Cheson Criteria [ Time Frame: 2 years ]Overall response = Complete response (CR) + Partial response (PR) CR = all previously enlarged fluorodeoxyglucose (FDG)-avid or positron emission tomography (PET)-positive lymph nodes regressed to normal size (<=1.5cm in greatest diameter) PR = >=50% decrease in SPD of up to six largest dominant masses, no increase in size of other nodes; FDG avid or PET positive before therapy, one or more nodes PET positive at previously involved site, or variably FDG avid or PET negative with regression at CT
- Progression-free Survival [ Time Frame: 2 years and medium follow-up of 18 months ]Progression-free survival: a patient lives with the disease but it does not get worse.
- Overall Survival [ Time Frame: 2 years ]Overall survival: patients are still alive.
- Safety [ Time Frame: 2 years ]Toxicities are graded 1 (mild), 2 (moderate), 3 (severe), and 4 (life-threatening)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00722865
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Jeremy Abramson, MD||Massachusetts General Hospital|