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Diffuse Large B-cell LymphomaPhase 2NCT02660710

Rituximab Plus CHOP Chemotherapy for Diffuse Large B-cell Lymphoma

A Phase 2 study testing R-CHOP in people with Diffuse Large B-cell Lymphoma and HIV, run by UNC Lineberger Comprehensive Cancer Center at 1 site in Malawi.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Diffuse Large B-cell Lymphoma, HIV
What is being tested?
R-CHOP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteMalawi
Study dates
Mar 2016to 22 Jul 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

Malawi1 site

  • UNC Project, Lighthouse Trust

    Lilongwe

Other trials in Malawi

About this study

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

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.

Read the 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.

Being tested
R-CHOP
Keywords
single arm phase 2, safety and efficacy, R-CHOP
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • R-CHOPDrug

    Also called Indian generic biosimilar for rituximab, Reditux™

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

Study groups in NCT02660710
Study groupRoleWhat they receive
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
Receives: Drug: R-CHOP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 5 years

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

    Measured: 5 years

Secondary outcomes (8)

  1. 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

    Measured: 5 years

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

    Measured: 24 months

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

    Measured: 24 months

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

    Measured: 5 years

  5. Number of patients with overall survival with R-CHOP administered

    Measured: 5 years

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

    Measured: 24 months

  7. 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

    Measured: 5 years

  8. Number of years gained after rituximab plus CHOP chemotherapy administered

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2016 (estimated)
  2. Study startMar 2016
  3. Primary completion22 Jul 2021
  4. Study completion22 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02660710
Sponsor's protocol ID
LCCC 1335
Other IDs
K01TW009488, R21CA180815
Status last verified
Oct 2022
First submitted
17 Jan 2016
Last updated
28 Oct 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 34022150

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing R-CHOP in people with Diffuse Large B-cell Lymphoma and HIV, run by UNC Lineberger Comprehensive Cancer Center at 1 site in Malawi.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of DLBCL patients receiving R-CHOP who experience NCI grade 3 or 4 non-hematologic toxicities (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02660710, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.

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