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

  • STATUS
    Recruiting
  • End date
    Aug 25, 2026
  • participants needed
    27
  • sponsor
    UNC Lineberger Comprehensive Cancer Center
Updated on 25 May 2022

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.

Description

This study aims to determine the safety and efficacy of first-line, risk-stratified rituximab-based MCD treatment in Malawi in a single-arm, phase II clinical trial. The investigators will enroll 27 subjects with newly diagnosed or previously treated MCD (who have not previously received rituximab) requiring treatment (B symptoms or hemoglobin <10 g/dL). Subjects will be treated with four weekly doses of rituximab. High-risk subjects (defined as patients with Eastern Cooperative Oncology Group (ECOG) performance status >2 or hemoglobin <8 g/dL) will also receive etoposide chemotherapy. Subjects will be followed for one year for toxicity and two years for survival. The primary outcome will be safety, defined as the frequency of ≥Grade 3 treatment-related Common Terminology Criteria for Adverse Events (AEs). Secondary outcomes will be event-free survival (death, progression, or development of NHL) and 1- and 2-year overall survival (OS). The investigators also aim to compare the cost-effectiveness of first-line rituximab treatment for MCD in Malawi to chemotherapy (using the investigators' historical controls).

Details
Condition Multicentric Castleman Disease
Treatment Rituximab, etoposide
Clinical Study IdentifierNCT04585893
SponsorUNC Lineberger Comprehensive Cancer Center
Last Modified on25 May 2022

Eligibility

Yes No Not Sure

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)
Lymphadenopathy or hepatosplenomegaly
At least one of the following signs or symptoms attributable to MCD by the local study investigator
Weight loss >5%
Malaise
Anemia (Hemoglobin <10 g/dL) within the past 4 weeks
Thrombocytopenia (Platelets <100 x 103/mL) NOTE: If only two of the three criteria are present, but the provider feels treatment is indicated for a symptomatic MCD flare, this will be allowed after communication with the study principal investigator (PI)
Females of childbearing potential must have a negative urine pregnancy test within
NOTE: Females are considered of childbearing potential unless they are
three days prior to registration
surgically sterile (have undergone a hysterectomy, bilateral tubal ligation
or bilateral oophorectomy) or they are naturally postmenopausal for at least
consecutive months. Documentation of postmenopausal status must be
provided
Females must agree to abstain from breast-feeding during therapy and for 6 months after the completion of therapy
Females of childbearing potential must be willing to abstain from heterosexual activity or to use two forms of effective methods of contraception from the time of informed consent until 12 months after treatment discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method, or an intrauterine device that meets <1% failure rate for protection from pregnancy in the product label
Male subjects with female partners must have had a prior vasectomy or agree to use an adequate method of contraception (i.e., double barrier method: condom plus spermicidal agent) starting with the first dose of study therapy through 6 months after the last dose of study therapy
At least 7 days without corticosteroid use prior to start of treatment

Exclusion Criteria

More than 7 days of corticosteroids immediately prior to enrollment. If subject is taking corticosteroid for more than 7 days, they require a 7 day washout period before enrollment
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
Pregnant or breastfeeding (Note: Breast milk cannot be stored for future use while the mother is being treated on the study)
Second active malignancy requiring systemic therapy
If HIV negative and a) hepatitis B virus surface antigen positive or b) 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
Active infection requiring systemic therapy
Treatment with any investigational drug within 28 days prior to registration
Bilirubin >3 mg/dL
Creatinine clearance <30 ml/min by Cockcroft-Gault formula
ECOG performance status >3\
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