NCT02660710

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2016

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 21, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2022

Completed
Last Updated

October 28, 2022

Status Verified

October 1, 2022

Enrollment Period

5.4 years

First QC Date

January 17, 2016

Last Update Submit

October 27, 2022

Conditions

Diffuse Large B-cell LymphomaHIV

Keywords

single arm phase 2safety and efficacyR-CHOP

Outcome Measures

Primary Outcomes (2)

  • 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.

    5 years

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

    5 years

Secondary Outcomes (8)

  • 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

    5 years

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

    24 months

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

    24 months

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

    5 years

  • Number of patients with overall survival with R-CHOP administered

    5 years

  • +3 more secondary outcomes

Study Arms (1)

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

Drug: R-CHOP

Interventions

R-CHOPDRUG

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

Also known as: Indian generic biosimilar for rituximab, Reditux™
R-CHOP

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Project, Lighthouse Trust

Lilongwe, Malawi

Location

Related Publications (1)

  • 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.

    PMID: 34022150DERIVED

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

R-CHOP protocolRituximabReditux

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Matthew Painschab, MD

    University of North Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2016

First Posted

January 21, 2016

Study Start

March 1, 2016

Primary Completion

July 22, 2021

Study Completion

July 22, 2022

Last Updated

October 28, 2022

Record last verified: 2022-10

Locations

MA(1)