Status:
TERMINATED
Rituximab Hyaluronidase in Combination With Chemotherapy in Treating Aggressive B-cell Lymphoma in Uganda
Lead Sponsor:
Fred Hutchinson Cancer Center
Conditions:
Burkitt Lymphoma
KSHV-associated Multicentric Castleman Disease
Eligibility:
All Genders
2+ years
Phase:
PHASE1
Brief Summary
This phase I trial studies how well rituximab hyaluronidase and combination chemotherapy work in treating patients in Uganda with Burkitt lymphoma, diffuse large B-cell lymphoma, or Kaposi sarcoma her...
Detailed Description
OUTLINE: Open-label Phase I study characterizing the safety, tolerability, and activity of subcutaneous rituximab hyaluronidase (sqR) alone (KSHV-MCD), or combined with local standard of care chemoth...
Eligibility Criteria
Inclusion
- Histology and immunohistochemistry (CD20+) confirmed Burkitt lymphoma (BL), diffuse large B-cell lymphoma (DLBCL), or histology confirmed KSHV-associated multicentric Castleman disease with elevated blood KSHV viral load
- Cohort 1: Age should be equal to or greater than 15
- Cohort 2: Age: 2-15
- Measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
- Able to provide informed consent (adults) or assent (children \< 18 years) in English or Luganda
- Human immunodeficiency virus (HIV)-infected patients eligible if meet the following criteria:
- CD4+ T-cell count \> 200 cells/uL
- HIV treatable with effective antiretroviral therapy that does not include agents with known significant drug-drug interactions with accompanying chemotherapy (ritonavir and cobicistat contraindicated)
Exclusion
- Previous therapy for lymphoma or KSHV-multicentric Castleman disease (MCD)
- History of hypersensitivity to rituximab
- Pregnant or nursing women. Men or women may not participate unless they have agreed to use effective contraception during treatment and for 12 months following completion of therapy
- Inadequate organ function, unless attributed to lymphoma or KSHV-MCD
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \> 2.5 times upper limit of normal
- Creatinine \> 2 times upper limit than normal or calculated creatinine clearance \< 60 mL/min
- New York Heart Association (NYHA) cardiac failure class III or IV
- Patients with clinically significant anemia-hemoglobin less than 10 g/dL
- Central nervous system (CNS) masses consistent with lymphoma or untreated infection; leptomeningeal disease will not be excluded
- Patients with malignancy within 5 years, other than resected local skin cancer or limited Kaposi sarcoma (KS) (no known pulmonary KS)
- Patients with evidence of active infections including malaria and hepatitis B (participants with hepatitis B virus \[HBV\] controlled on antivirals will not be excluded)
Key Trial Info
Start Date :
October 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 26 2023
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03864419
Start Date
October 24 2019
End Date
July 26 2023
Last Update
January 3 2024
Active Locations (1)
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1
UCI-Fred Hutch Cancer Centre
Kampala, Uganda