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Randomized, Phase II Trial of CHOP vs. Oral Chemotherapy With Concomitant Antiretroviral Therapy in Patients With HIV-Associated Lymphoma in Sub-Saharan Africa
This randomized phase II trial studies how well intravenous (IV) chemotherapy or oral chemotherapy works in treating patients with previously untreated stage III-IV human immunodeficiency virus (HIV)-associated non-Hodgkin lymphoma. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, prednisone, lomustine, etoposide, and procarbazine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells
PRIMARY OBJECTIVES: I. To compare the efficacy of standard cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (CHOP) and an oral chemotherapy regimen for acquired immune deficiency syndrome (AIDS)-related (AR)-non-Hodgkin lymphoma (NHL) in sub-Saharan Africa with respect to overall survival (OS). SECONDARY OBJECTIVES: I. To compare the objectives response rate (ORR) of persons randomized to CHOP and oral chemotherapy. II. To compare the progression free survival (PFS) of persons randomized to CHOP and oral chemotherapy. III. To compare the safety and tolerance of persons randomized to CHOP and oral chemotherapy. TERTIARY OBJECTIVES: I. To describe the rates of completion of therapy of persons randomized to CHOP and oral chemotherapy. II. To describe adherence to chemotherapy of persons randomized to CHOP and oral chemotherapy. III. To describe adherence to antiretroviral therapy of persons randomized to CHOP and oral chemotherapy. IV. To describe the effects of therapy on HIV control, as measured by cluster of differentiation (CD)4 counts and HIV viral load. V. To investigate correlates of survival. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive CHOP chemotherapy comprising cyclophosphamide intravenously (IV) on day 1, doxorubicin hydrochloride IV on day 1, vincristine sulfate IV on day 1, and prednisone orally (PO) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive lomustine PO once daily (QD) on day 1 (courses 1 and 3 only), etoposide PO QD on days 1-3, cyclophosphamide PO QD on days 22-26, and procarbazine hydrochloride PO QD on days 22-26. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 3, 6, 12, 18, and 24 months.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Moi Teaching and Referral Hospital
Eldoret, Kenya
University of Zimbabwe College of Health Sciences
Harare, Zimbabwe
Start Date
September 15, 2016
Primary Completion Date
April 1, 2021
Completion Date
July 15, 2021
Last Updated
October 10, 2022
7
ACTUAL participants
cyclophosphamide
DRUG
doxorubicin hydrochloride
DRUG
vincristine sulfate
DRUG
prednisone
DRUG
lomustine
DRUG
etoposide
DRUG
cyclophosphamide
DRUG
procarbazine hydrochloride
DRUG
laboratory biomarker analysis
OTHER
Lead Sponsor
AIDS Malignancy Consortium
Collaborators
NCT01769911
NCT00049036
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