Safety and Efficacy of Rituximab for Treatment of Multicentric Castleman Disease in Malawi

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT04585893
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Multicentric Castleman Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    375 mg/m\^2 administered via IV infusion weekly for four weeks. Administered via slow IV infusion, starting at 50mg/hr and increasing by 50mg/hr every 30 minutes to a maximum infusion rate of 400mg/hr.
  • Etoposide — DRUG
    Subjects with high-risk disease will receive 100 mg/m\^2 etoposide weekly for four weeks administered over one hour via IV infusion after completion of rituximab

Study Details

The purpose of this study is to determine the safety and efficacy of first-line, risk-stratified Rituximab-based Multicentric Castleman Disease (MCD) treatment in Malawi in a single-arm, phase II clinical trial. This study also aims to compare the cost-effectiveness of first-line Rituximab treatment for MCD in Malawi to chemotherapy.

Key Dates

Start date
Jun 22, 2021
Status verified
Sep 2025
Primary completion
Aug 30, 2024
Completion
Jun 7, 2026

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm Rituximab
    The safety and efficacy of first-line rituximab will be assessed through a risk-stratified rituximab-based Multicentric Castleman disease (MCD) The planned sample size is 27 adult patients accrued at a rate of 10 patients annually. High-risk patients (defined as patients with ECOG performance status \>2 or hemoglobin \<8 g/dL) will receive four weekly doses of rituximab (375 mg/m2) and etoposide (100 mg/m2). Low-risk patients will receive the same dose of rituximab (four weekly doses at 375 mg/m2) alone.

Primary Outcome Measure

Number of Participant With Non-hematologic Grade ≥3 Adverse Events (AEs) [ Time Frame: From the start of rituximab-based therapy to 12 weeks. (Up to 13 weeks) ]

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