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.
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
Drug | Synonyms | Arms |
---|
R-CHOP | Indian generic biosimilar for rituximab, Reditux™ | R-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
Name | Type | Description | Interventions |
---|
R-CHOP | Experimental | We 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 | |
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: | Active, not recruiting |
Lead Sponsor: | UNC Lineberger Comprehensive Cancer Center |
Trial Keywords
- single arm phase 2
- safety and efficacy
- R-CHOP
Last Updated
December 17, 2020