Clinical Trials /

Rituximab Plus CHOP Chemotherapy for Diffuse Large B-cell Lymphoma

NCT02660710

Description:

The purpose of this study is to establish the safety of rituximab plus cyclophosphamide, doxorubicin, vincristine,prednisone (R-CHOP) in HIV-infected and HIV-uninfected diffuse large B-cell lymphoma (DLBCL) patients in Malawi.

Related Conditions:
  • Diffuse Large B-Cell Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Rituximab Plus CHOP Chemotherapy for Diffuse Large B-cell Lymphoma
  • Official Title: LCCC 1335: A Single-Arm Phase I/II Clinical Trial of Rituximab Plus CHOP Chemotherapy for Diffuse Large B-cell Lymphoma in Malawi

Clinical Trial IDs

  • ORG STUDY ID: LCCC 1335
  • SECONDARY ID: K01TW009488
  • SECONDARY ID: R21CA180815
  • NCT ID: NCT02660710

Conditions

  • Diffuse Large B-cell Lymphoma
  • HIV

Interventions

DrugSynonymsArms
R-CHOPIndian generic biosimilar for rituximab, RedituxR-CHOP

Purpose

The purpose of this study is to establish the safety of rituximab plus cyclophosphamide, doxorubicin, vincristine,prednisone (R-CHOP) in HIV-infected and HIV-uninfected diffuse large B-cell lymphoma (DLBCL) patients in Malawi.

Detailed Description

      The study is a single-center, non-randomized phase II clinical trial of R-CHOP for
      CD20-positive DLBCL, using the Indian generic biosimilar for rituximab, Reditux™. The
      investigators will enroll 40 adult patients age 18-60 years (20 HIV-infected with CD4 count ≥
      100 cells/µL, 20 HIV-uninfected) who will receive a maximum of 6-8 cycles of R-CHOP over
      18-24 weeks. The primary goal of this study is to establish the safety of R-CHOP in the
      Malawi population.

      Secondary objectives of the study include estimates of complete response (CR) rates,
      progression-free survival (PFS), and overall survival (OS). In addition, quality of life,
      costs of care, study patient characteristics, clinical outcomes and other published data from
      the region will be collected and used to evaluate the cost-effectiveness of R-CHOP. If the
      investigators' study supports incorporating rituximab into treatment regimens in sub-Saharan
      Africa, this strategy can be examined in larger trials, and provide momentum to increase
      access to modern cancer medicines globally.
    

Trial Arms

NameTypeDescriptionInterventions
R-CHOPExperimentalWe will enroll 40 adult patients age 18-60 years (20 HIV-infected with CD4 count ≥ 100 cells/µL, 20 HIV-uninfected) who will receive a maximum of 6-8 cycles of rituximab plus cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP) over 18-24 weeks
  • R-CHOP

Eligibility Criteria

        Inclusion Criteria:

          -  Informed consent obtained and signed. Age 18-60 years. ECOG performance status (PS)
             0-2. Histologically confirmed CD20-positive DLBCL, any stage, bulky or nonbulky
             disease.

          -  No prior treatment for lymphoma. Willing to have documentation of HIV status. CD4
             count ≥ 100 cells/µL if HIV-infected. Measurable disease by physical exam.

          -  Adequate bone marrow renal and hepatic function as evidenced by the following:

               -  Absolute neutrophil count (ANC) ≥ 1,000/µL

               -  Platelet count ≥ 100,000/µL

               -  Creatinine ≤ 1.5 mg/dL

               -  Total bilirubin ≤ 2 mg/dL (unless directly attributable to lymphoma)

          -  Able to understand and comply with protocol requirements for the entire length of the
             study.

          -  Willing to reside <50 kilometers from Kamuzu Central Hospital (KCH) until chemotherapy
             completion.

          -  Negative urine B-HCG in women of child-bearing potential within 7 days prior to start
             of treatment.

          -  Fertile patients must use effective contraception (condom or other barrier methods,
             oral contraceptives, implantable contraceptives, intrauterine devices) during and for
             six months after completion of treatment.

        Exclusion Criteria

          -  Pregnant or nursing. Central nervous system (CNS) involvement by lymphoma (clinically
             or cytologically confirmed).

          -  Receiving other anti-cancer or investigational therapy during study treatment, apart
             from those agents specified in the study protocol.

          -  Known cardiac disease including any of the following:

               -  New York Heart Association (NYHA) Grade II or greater congestive heart failure

               -  History of myocardial infarction or unstable angina within 6 months prior to Day
                  1

               -  History of stroke or transient ischemic attack within 6 months prior to Day 1

          -  Second active malignancy requiring systemic therapy.

          -  Hepatitis B virus (HBV) surface-antigen positive unless receiving both tenofovir and
             lamivudine as part of antiretroviral therapy if HIV-infected.

          -  Other serious, ongoing, non-malignant disease or infection that would in the opinion
             of the site investigator compromise other protocol objectives.
      
Maximum Eligible Age:60 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of DLBCL patients receiving R-CHOP who experience NCI grade 3 or 4 non-hematologic toxicities
Time Frame:5 years
Safety Issue:
Description:Safety will be assessed by grading toxicity events according to NCI Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAEv4) other than for hypersensitivity reactions to rituximab. Toxicities will be assessed, graded and documented by investigators at each clinic visit, and then tabulated.

Secondary Outcome Measures

Measure:Number of DLBCL patients by HIV status receiving R-CHOP who experience grade 3 or 4 non-hematologic toxicities over a course of six cycles
Time Frame:5 years
Safety Issue:
Description:
Measure:Number of patients receiving ≥ 90% of the prescribed doses of doxorubicin and cyclophosphamide, respectively among DLBCL patients in Malawi with HIV infection
Time Frame:24 months
Safety Issue:
Description:
Measure:Number of patients receiving ≥ 90% of the prescribed doses of doxorubicin and cyclophosphamide, respectively among DLBCL patients in Malawi without HIV infection
Time Frame:24 months
Safety Issue:
Description:
Measure:Number of patients with progression free survival with R-CHOP administered
Time Frame:5 years
Safety Issue:
Description:
Measure:Number of patients with overall survival with R-CHOP administered
Time Frame:5 years
Safety Issue:
Description:
Measure:Number of patients with complete response rates with R-CHOP administered
Time Frame:24 months
Safety Issue:
Description:
Measure:Number of years from treatment initiation until disease progression or death.
Time Frame:5 years
Safety Issue:
Description:Questionnaire - health-related quality of life (via the EORTC QLQ-C30) among DLBCL patients in Malawi overall and with and without HIV infection receiving R-CHOP
Measure:Number of years gained after rituximab plus CHOP chemotherapy administered
Time Frame:5 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:UNC Lineberger Comprehensive Cancer Center

Trial Keywords

  • single arm phase 2
  • safety and efficacy
  • R-CHOP

Last Updated

August 9, 2019