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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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 Summary:

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,
Sponsor: AIDS Malignancy Consortium

Current Primary Outcome:

  • Overall survival [ Time Frame: Up to 24 months ]
    The log-rank test will be used to compare the two treatment arms with respect to overall survival. The one-sided 0.20 significance level will be used for this comparison. Proportional hazards models will be used to evaluate the association between covariates (e.g., CD4 count and HIV viral load) and overall survival.
  • Overall response rate [ Time Frame: Up to 24 months ]
    The overall response rate will be estimated for each of the treatment arms using the binomial proportion and its 95% confidence interval. The two arms will be compared with respect to overall response rate using Fisher's exact test.
  • Progression-free survival [ Time Frame: Up to 24 months ]
    The log-rank test will be used to compare the two treatment arms with respect to progression-free survival.
  • Frequency and severity of adverse events, assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 24 months ]
    For each treatment arm, the frequency and severity of adverse events will be summarized. For adverse events that occur in more than 5% of either arm, the two treatment arms will be compared with respect to the proportion of patients who experience that adverse event using Fisher's exact test.
  • Proportion of patients who complete treatment [ Time Frame: Up to 18 weeks ]
    The two treatment arms will be compared using Fisher's exact test.

    • Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: AIDS Malignancy Consortium

    Dates:
    Date Received: January 23, 2013
    Date Started: September 2016
    Date Completion: January 2021
    Last Updated: September 29, 2016
    Last Verified: June 2016