Lymphoma
Conditions
Keywords
Hodgkin's Disease, Lymphoma, Rituximab, Rituxan, Adriamycin, Doxorubicin, Rubex, Bleomycin, Bleomycin sulfate, Blenoxane, BLM, Dacarbazine, DTIC, DTIC-Dome, Vincristine, Vinblastine, Vinblastine Sulfate, ABVD, ABVD Chemotherapy Treatment
Brief summary
Primary Objective: \- 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.
Detailed description
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.
Interventions
DRUGRituximab
375 mg/m\^2 by vein over 3 to 8 hours weekly for 6 weeks in a row.
DRUGAdriamycin
25 mg/m\^2 injected by vein over 3 hours every other week for a total of 12 treatments.
DRUGBleomycin
10 U/m\^2 injected by vein over 3 hours every other week for a total of 12 treatments.
DRUGVinblastine
6 mg/m\^2 injected by vein over 3 hours every other week for a total of 12 treatments.
375 mg/m\^2 injected by vein over 3 hours every other week for a total of 12 treatments.
Sponsors
Genentech, Inc.
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Hodgkin's disease patients who relapse after radiation therapy alone and previously untreated patients with stage II bulky, III and IV who are eligible for ABVD. 2. Must have histologically proven diagnosis of Hodgkin's disease (Nodular sclerosis or mixed cellularity). 3. Must have bidimensionally measurable disease. 4. Must sign a consent form. 5. Must be older than 16 years of age. 6. Must have adequate bone marrow reserve (ANC \> 1,000/microL, Platelet \> 100,000/microL 7. Left Ventricular Ejection Fraction (LVEF) \>/= 50% by multigated acquisition (MUGA) scan or echocardiogram. 8. Serum creatinine \< 2 mg/dl, serum bilirubin \< 2 mg/dl
Exclusion criteria
1. HIV positive. 2. Pregnant women and women of child bearing age who are not practicing adequate contraception. 3. Prior chemotherapy. 4. Severe pulmonary disease including Chronic obstructive pulmonary disease (COPD) and asthma.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5-year Failure-free Survival Rate for Participants With Hodgkin's Disease Given Rituximab With ABVD | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment Period: March 09, 2001 to August 29, 2007. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
Pre-assignment details
Of the 85 participants enrolled, three participants were excluded prior to assignment to groups as ineligible.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 82 |
| Total | 82 |
Baseline characteristics
| Characteristic | Rituximab + ABVD Chemotherapy |
|---|---|
| Age Continuous | 32 years |
| Region of Enrollment United States | 82 participants |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 82 / 82 |
| serious Total, serious adverse events | 40 / 82 |
Outcome results
Primary
5-year Failure-free Survival Rate for Participants With Hodgkin's Disease Given Rituximab With ABVD
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.
Time frame: Baseline to 5 Years or until disease progression
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rituximab + ABVD Chemotherapy | 5-year Failure-free Survival Rate for Participants With Hodgkin's Disease Given Rituximab With ABVD | 83 percentage of participants |