Status:
COMPLETED
Study of Rituximab-HCVAD Alternating With Rituximab-Methotrexate-Cytarabine Versus Standard Rituximab-CHOP Every 21 Days for Patients With Newly Diagnosed High Risk Aggressive B-Cell Non-Hodgkin's Lymphomas in Patients 60 Years Old or Younger
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Lymphoma
Eligibility:
All Genders
16-60 years
Phase:
PHASE2
Brief Summary
The overall goal of this clinical research study was to find out which of two different chemotherapy drug combinations, R-CHOP and R-HCVAD, is more effective in treating B-cell lymphoma. At this poin...
Detailed Description
This study originally involved 2 different study drug regimens, R-CHOP and R-HCVAD. R-CHOP is made up of rituximab, cyclophosphamide, vincristine, and prednisone, and is the most common treatment for ...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of previously untreated large B-cell Non Hodgkin's, Large Cell Lymphoma and B-Cell with high grade features. Other aggressive lymphomas such as Primary Mediastinal large B-cell Lymphomas will be also allowed to be included.
- Patients with performance status of 0-2 (Zubrod Scale).
- Serum bilirubin \<1.5 mg/dl and serum creatinine \< 2.0 mg/dl unless due to lymphoma; absolute neutrophil count (ANC) \>1000/mm\^3 and platelets \>100,000/mm\^3 unless due to lymphoma.
- Cardiac ejection fraction 50% or greater.
- Ages 16 - 60 years (due to the fact that CHOP-R is not studied enough in younger patients and is not considered standard of care).
- Patients must be willing to receive transfusions of blood products.
- Age adjusted International Prognostic Index Score of 2 or more
- Previous steroids are allowed (if used to relieve some symptoms such as SVC, etc).
Exclusion
- Pregnancy (excluded due to the teratogenicity of the involved chemotherapy agents
- Positive HIV serology because of poor tolerance to this intense chemotherapy regimen
- Burkitt's lymphomas, and Mantle cell lymphoma, transformed follicular center cell lymphoma, follicular grade III.
- Any clinical or cytological diagnosis of central nervous system (CNS) involvement
- Any co-morbid medical, such as Child's Class C liver cirrhosis, end-stage renal disease, and symptomatic congestive heart failure, or psychiatric illnesses that preclude treatment with intense dose chemotherapy as determined by the primary investigator.
- Concurrent or previous malignancy whose prognosis is poor (\< 90% probability of survival at 5 years)
- Active Hepatitis B or C. Chronic carriers for Hepatitis B will be excluded.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 11 2017
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00290498
Start Date
August 1 2005
End Date
August 11 2017
Last Update
June 2 2020
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030