Mode
Text Size
Log in / Sign up
Phase 2 Completed N=59 Randomized Treatment

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

Back to search