Rituximab Hyaluronidase in Combination With Chemotherapy in Treating Aggressive B-cell Lymphoma in Uganda

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2024
• Main ID: NCT03864419
• Date of registration: 01/03/2019
• Prospective Registration: Yes
• Primary sponsor: Fred Hutchinson Cancer Center
• Public title: Rituximab Hyaluronidase in Combination With Chemotherapy in Treating Aggressive B-cell Lymphoma in Uganda
• Scientific title: A Phase I Study of Subcutaneous Rituximab Hyaluronidase Combined With Local Standard-of-Care Chemotherapy for the Treatment of Burkitt Lymphoma, Diffuse Large B-Cell Lymphoma or as Monotherapy for Kaposi Sarcoma Herpesvirus Associated Multicentric Castleman Disease in Pediatrics and Adults in Uganda
• Date of first enrolment: October 24, 2019
• Target sample size: 18
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT03864419
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Uganda, United States

Contacts

• Name: Manoj Menon, MD
• Affiliation: Fred Hutch/University of Washington Cancer Consortium

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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)



Age minimum: 2 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Diffuse Large B-Cell Lymphoma

KSHV-associated Multicentric Castleman Disease

Burkitt Lymphoma

Intervention(s)

Drug: Doxorubicin Hydrochloride

Drug: Doxorubicin

Drug: Vincristine

Biological: Rituximab

Biological: Rituximab and Hyaluronidase Human

Drug: Methotrexate

Drug: Prednisone

Drug: Cyclophosphamide

Drug: Etoposide

Primary Outcome(s)

Number of participants that result in sufficient pharmacodynamic criteria [Time Frame: Up to 12 months]

Incidence of treatment-emergent adverse events [Time Frame: Up to 12 months]

Secondary Outcome(s)

Progression-free survival [Time Frame: 1 year]

Disease-free survival [Time Frame: 1 year]

Number of participants achieving a repose of complete response (CR) [Time Frame: 1 year]

Overall survival [Time Frame: 1 year]

Secondary ID(s)

10040

U028

RG1001799

NCI-2019-01493

Source(s) of Monetary Support

Please refer to primary and secondary sponsors