Rituximab and ABVD for Hodgkin's Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00504504|
Recruitment Status : Completed
First Posted : July 20, 2007
Results First Posted : July 9, 2013
Last Update Posted : July 9, 2013
- To determine the feasibility, toxicity, and efficacy of Rituximab with standard dose ABVD combination chemotherapy.
ABVD combination chemotherapy consists of Adriamycin, Bleomycin, Vinblastine and DTIC.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: Rituximab Drug: Adriamycin Drug: Bleomycin Drug: Vinblastine Drug: Dacarbazine (DTIC)||Phase 2|
Before treatment starts, patients will have a physical exam. Bone marrow samples will be taken. Blood samples (4 to 8 tablespoons) will be taken before and during the study. A chest x-ray, CT scans of the abdomen and pelvis, and a gallium scan will be done if necessary.
Patients in this study will receive rituximab by vein over 3 to 8 hours weekly for 6 weeks in a row. ABVD will be injected over 3 hours every other week for a total of 12 treatments. On the cycles where both rituximab and ABVD are given, rituximab will be given on day 1, and ABVD will be given on day 2. Response to therapy will be determined after 3 months and at the end of therapy (6 months). At the end, patients may receive radiation therapy to areas of large masses. All treatments can be given in an outpatient setting.
Scans and x-rays will be repeated if needed after completion of therapy and every 3 months from then on. If tumors do not shrink after 3 months of therapy, patients will be offered a different treatment.
This is an investigational study. Although ABVD is considered the standard treatment for patients with Hodgkin's disease, the combination of ABVD with rituximab is considered investigational. All drugs involved in this study are commercially available and are approved by the FDA. Up to 85 patients will take part in this study. All will be enrolled at M. D. Anderson. This protocol is partially funded by a research grant from Genentech.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||85 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Rituximab + ABVD for Patients With Hodgkin's Disease|
|Study Start Date :||March 2001|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2012|
Experimental: Rituximab + ABVD Chemotherapy
Rituximab 375 mg/m^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m^2 IV, Bleomycin 10 U/m^2 IV, Vinblastine 6 mg/m^2 IV, DTIC 375 mg/m^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.
375 mg/m^2 by vein over 3 to 8 hours weekly for 6 weeks in a row.
Other Name: Rituxan
25 mg/m^2 injected by vein over 3 hours every other week for a total of 12 treatments.
10 U/m^2 injected by vein over 3 hours every other week for a total of 12 treatments.
6 mg/m^2 injected by vein over 3 hours every other week for a total of 12 treatments.
Drug: Dacarbazine (DTIC)
375 mg/m^2 injected by vein over 3 hours every other week for a total of 12 treatments.
Other Name: DTIC-Dome
- 5-year Failure-free Survival Rate for Participants With Hodgkin's Disease Given Rituximab With ABVD [ Time Frame: Baseline to 5 Years or until disease progression ]Five year Event Free Survival (EFS) is proportion of surviving participants who remain event free out of total participants at 5 years after receiving Rituximab + ABVD (RABVD). Event-free Survival (EFS) analyzed every 6 months.
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): NCT00504504
|United States, Texas|
|UT MD . Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Anas Younes, MD||M.D. Anderson Cancer Center|