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

NCT04585893 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-09-11

Study results available
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Summary

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.

Conditions

  • Multicentric Castleman Disease

Interventions

DRUG

Rituximab

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.

DRUG

Etoposide

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

Sponsors & Collaborators

  • Fogarty International Center of the National Institute of Health

    collaborator NIH

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Matthew Painschab, MD · University of North Carolina

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-22
Primary Completion
2024-08-30
Completion
2026-06-07

Countries

  • Malawi

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04585893 on ClinicalTrials.gov