Randomized Trial of CHOP Chemotherapy With or Without Rituximab (Chimeric Anti-CD20 Antibody) for HIV-Associated Non-Hodgkin's Lymphoma
filgrastim
+ rituximab
+ CHOP regimen
Burkitt Lymphoma+14
+ DNA Virus Infections
+ Hemic and Lymphatic Diseases
Treatment Study
Summary
Study start date: January 1, 1999
Actual date on which the first participant was enrolled.OBJECTIVES: I. Compare the efficacy of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) with or without rituximab in patients with previously untreated HIV-associated non-Hodgkin's lymphoma. II. Determine the efficacy of rituximab as maintenance therapy following remission induction with CHOP in these patients. III. Determine the effect of rituximab on the immune system and HIV viral load in these patients. IV. Determine the relationship between EBV load and the presence of EBV in lymphoma tumor cells of these patients. V. Compare the effect of CHOP with or without rituximab on EBV load in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified by extent of disease (stage I/II vs III/IV). Patients are randomized to 1 of 2 treatment arms: Arm I: Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 3 and oral prednisone on days 3-7. Patients receive rituximab on day 1. Treatment repeats every 3 weeks for a minimum of 4 courses or 2 courses beyond complete response in the absence of disease progression or unacceptable toxicity. Patients with stage I, stage IE (including bulky), or nonbulky stage II or IIE disease receive 3 courses of chemotherapy with rituximab followed by radiotherapy beginning 3 weeks after completion of the third course. Patients who achieve partial response for a minimum of 28 days or complete response receive maintenance rituximab IV beginning on day 28 of the final course of chemotherapy. Maintenance rituximab treatment repeats every 4 weeks for 3 courses. Arm II: Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 and oral prednisone on days 1-5. Treatment repeats every 3 weeks for a minimum of 4 courses or 2 courses beyond complete response. Patients with stage I, stage IE (including bulky), or nonbulky stage II or IIE disease receive 3 courses of chemotherapy. Patients receive radiotherapy beginning 3 weeks after completion of the third course of chemotherapy. Both arms: Patients receive filgrastim (G-CSF) subcutaneously beginning on day 4 and continuing through day 13 of each chemotherapy course or until blood counts recover. Patients are followed every 4 weeks for 1 year and then every 2 months until death.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.120 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: * Histologically or cytologically proven HIV-associated B cell non-Hodgkin's lymphoma, including: * Diffuse large B cell lymphoma * Intermediate grade diffuse large cell lymphoma * High grade large cell immunoblastic lymphoma * Burkitt's lymphoma * High grade B cell lymphoma, Burkitt's like (small noncleaved lymphoma) * No primary CNS lymphoma (parenchymal brain or spinal cord tumor) * Evaluable disease HIV documentation may be serologic (ELISA or western blot), culture, or quantitative PCR or bDNA assay Tumors must be CD20 positive (greater than 50% cells express CD20) * A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: * Age: Over 18 * Performance status: Karnofsky 70-100% * Absolute neutrophil count greater than 1,000/mm3\* * Platelet count greater than 75,000/mm3\* \* Unless cytopenias are secondary to lymphoma * Bilirubin less than 2.0 mg/dL (unless secondary to hepatic infiltration with lymphoma or isolated hyperbilirubinemia associated with the use of indinavir) * SGOT or SGPT less than 7 times upper limit of normal * Creatinine less than 2.0 mg/dL (unless due to lymphoma) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No acute, active HIV-associated opportunistic infection requiring antibiotics * Mycobacterium avium complex allowed * No concurrent malignancy except carcinoma in situ of the cervix, nonmetastatic nonmelanomatous skin cancer, or Kaposi's sarcoma not requiring systemic chemotherapy PRIOR CONCURRENT THERAPY: * Prior or concurrent epoetin alfa or filgrastim (G-CSF) allowed * No prior colony stimulating factor therapy within 24 hours prior to chemotherapy * No prior chemotherapy for HIV-associated non-Hodgkin's lymphoma * At least 1 year since prior cyclophosphamide or doxorubicin * No prior radiotherapy for HIV-associated non-Hodgkin's lymphoma * Chronic therapy with myelosuppressive agents allowed * Concurrent antiretroviral therapy, antifungal medications, and antibiotics allowed
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 13 locations
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, United StatesOpen USC/Norris Comprehensive Cancer Center and Hospital in Google MapsJonsson Comprehensive Cancer Center, UCLA
Los Angeles, United StatesSan Francisco General Hospital Medical Center
San Francisco, United StatesSylvester Cancer Center, University of Miami
Miami, United States