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

Completed · Phase 2

Conditions studied: Lymphoma

In brief

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.

Key facts

Study ID

NCT00290498

Run by

M.D. Anderson Cancer Center

People needed

67

Starts

2005-08-01

Expected to finish

2017-08-11

Last updated by the study team

2020-06-02

Who can join

Age: 16 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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