Safety and Efficacy of Rituximab for Treatment of Multicentric Castleman Disease in Malawi (NCT04585893) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Safety and Efficacy of Rituximab for Treatment of Multicentric Castleman Disease in Malawi
Malawi15 participantsStarted 2021-06-22
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Newly diagnosed or previously treated subjects with KSHV-associated MCD that is pathologically confirmed by characteristic histologic features and latency-associated nuclear antigen (LANA) positivity by Immunohistochemistry (IHC).
✓. Age is greater than or equal 18 years old at time of consent.
✓. Can provide informed consent.
✓. HIV-infected or HIV-uninfected.
✓. If HIV-infected, must be on or willing to start antiretroviral therapy including lamivudine or tenofovir.
✓. Willing to comply with study visits.
✓. MCD treatment indicated based on the presence of a symptomatic MCD flare, defined as the presence of each of the following three criteria:
✓. Fever (subjective or objective)
Exclusion criteria
✕. Symptomatic, extensive-stage KS (T1 by the AIDS Clinical Trials Group (ACTG) staging system; T1 includes ulceration or edema from KS, raised or non-hard palate oral lesions, or any visceral involvement) requiring urgent treatment, to avoid potential rituximab-induced KS worsening.
✕. Previous rituximab use for MCD.
✕. Second active malignancy requiring systemic therapy.
✕. If HIV negative and a) hepatitis B virus surface antigen positive or b) a combination of HepB core antibody positive and HepB surface antibody negative (indicative of chronic infection) unless on tenofovir or lamivudine. All HIV-infected patients must be on tenofovir or lamivudine as part of the inclusion criteria.
What they're measuring
1
Number of Participant With Non-hematologic Grade ≥3 Adverse Events (AEs)
Timeframe: From the start of rituximab-based therapy to 12 weeks. (Up to 13 weeks)
✕. Treatment with any investigational drug within 28 days prior to registration.
✕. More than 7 days of corticosteroids immediately prior to enrollment. If the subject is taking corticosteroids for more than 7 days, they require a 7 day washout period before enrollment.