Phase 2
Completed N=59
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
Source: ClinicalTrials.gov NCT00290498 ↗Enrolled (actual)
59
Serious AEs
94.9%
Results posted
Jun 2020
Primary outcomePrimary: Response Rate R-HCVAD vs. R-CHOP — 40; 7; 2; 1 Participants
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 point, all participants will now be assigned to the R-HCVAD arm of the study. Researchers will study the safety and effectiveness of this drug combination.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Rate R-HCVAD vs. R-CHOP |
40; 7; 2; 1; 1; 1 | — |
| SECONDARY Progression Free Survival (Rate) |
35; 7 | — |
Eligibility Criteria
Inclusion Criteria
- 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 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00290498). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.