Trials / Completed

CompletedNCT01775475

Intravenous Chemotherapy or Oral Chemotherapy in Treating Patients With Previously Untreated Stage III-IV HIV-Associated Non-Hodgkin Lymphoma

Randomized, Phase II Trial of CHOP vs. Oral Chemotherapy With Concomitant Antiretroviral Therapy in Patients With HIV-Associated Lymphoma in Sub-Saharan Africa

Status: Completed
Phase: Phase 2
Study type: Interventional
Enrollment: 7 (actual)

Sponsor: AIDS Malignancy Consortium · Network
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

Interventions

Type	Name	Description
DRUG	cyclophosphamide	Given IV
DRUG	doxorubicin hydrochloride	Given IV
DRUG	vincristine sulfate	Given IV
DRUG	prednisone	Given PO
DRUG	lomustine	Given PO
DRUG	etoposide	Given PO
DRUG	cyclophosphamide	Given PO
DRUG	procarbazine hydrochloride	Given PO
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

Start date: 2016-09-15
Primary completion: 2021-04-01
Completion: 2021-07-15
First posted: 2013-01-25
Last updated: 2022-10-10
Results posted: 2022-10-10

Locations

2 sites across 2 countries: Kenya, Zimbabwe

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT01775475. Inclusion in this directory is not an endorsement.