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Rituximab Plus CHOP Chemotherapy for Diffuse Large B-cell Lymphoma

Primary Purpose

Diffuse Large B-cell Lymphoma, HIV

Status

Completed

Phase

Phase 2

Locations

Malawi

Study Type

Interventional

Intervention

R-CHOP

About this trial

This is an interventional treatment trial for Diffuse Large B-cell Lymphoma focused on measuring single arm phase 2, safety and efficacy, R-CHOP

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

UNC Project, Lighthouse Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

R-CHOP

Arm Description

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

Outcomes

Primary Outcome Measures

Number of DLBCL patients receiving R-CHOP who experience NCI grade 3 or 4 non-hematologic toxicities

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.

Number of patients who experience treatment-related death over a course of six cycles

Secondary Outcome Measures

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

Number of patients receiving ≥ 90% of the prescribed doses of doxorubicin and cyclophosphamide, respectively among DLBCL patients in Malawi with HIV infection

Number of patients receiving ≥ 90% of the prescribed doses of doxorubicin and cyclophosphamide, respectively among DLBCL patients in Malawi without HIV infection

Number of patients with progression free survival with R-CHOP administered

Number of patients with overall survival with R-CHOP administered

Number of patients with complete response rates with R-CHOP administered

Number of years from treatment initiation until disease progression or death.

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

Number of years gained after rituximab plus CHOP chemotherapy administered

Full Information

NCT ID

NCT02660710

First Posted

January 17, 2016

Last Updated

October 27, 2022

Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

Fogarty International Center of the National Institute of Health, National Institutes of Health (NIH), National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT02660710

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

March 2016 (undefined)

Primary Completion Date

July 22, 2021 (Actual)

Study Completion Date

July 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

Fogarty International Center of the National Institute of Health, National Institutes of Health (NIH), National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diffuse Large B-cell Lymphoma, HIV

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

R-CHOP

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

R-CHOP

Other Intervention Name(s)

Indian generic biosimilar for rituximab, Reditux™

Intervention Description

maximum of 6-8 cycles of R-CHOP over 18-24 weeks

Primary Outcome Measure Information:

Title

Number of DLBCL patients receiving R-CHOP who experience NCI grade 3 or 4 non-hematologic toxicities

Description

Time Frame

5 years

Title

Number of patients who experience treatment-related death over a course of six cycles

Time Frame

5 years

Secondary Outcome Measure Information:

Title

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

Title

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

Title

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

Title

Number of patients with progression free survival with R-CHOP administered

Time Frame

5 years

Title

Number of patients with overall survival with R-CHOP administered

Time Frame

5 years

Title

Number of patients with complete response rates with R-CHOP administered

Time Frame

24 months

Title

Number of years from treatment initiation until disease progression or death.

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

Time Frame

5 years

Title

Number of years gained after rituximab plus CHOP chemotherapy administered

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matthew Painschab, MD

Organizational Affiliation

University of North Carolina

Official's Role

Principal Investigator

Facility Information:

Facility Name

UNC Project, Lighthouse Trust

City

Lilongwe

Country

Malawi

12. IPD Sharing Statement

Citations:

PubMed Identifier

34022150

Citation

Kimani S, Painschab MS, Kaimila B, Kasonkanji E, Zuze T, Tomoka T, Mulenga M, Nyasosela R, Chikasema M, Mtangwanika A, Chawinga M, Mhango W, Nicholas S, Chimzimu F, Kampani C, Krysiak R, Lilly A, Randall C, Seguin R, Westmoreland KD, Montgomery ND, Fedoriw Y, Gopal S. Safety and efficacy of rituximab in patients with diffuse large B-cell lymphoma in Malawi: a prospective, single-arm, non-randomised phase 1/2 clinical trial. Lancet Glob Health. 2021 Jul;9(7):e1008-e1016. doi: 10.1016/S2214-109X(21)00181-9. Epub 2021 May 19.

Results Reference

derived

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Rituximab Plus CHOP Chemotherapy for Diffuse Large B-cell Lymphoma

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