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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 1 March 2021
Main ID:  NCT03864419
Date of registration: 01/03/2019
Prospective Registration: Yes
Primary sponsor: Fred Hutchinson Cancer Research 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: 40
Recruitment status: Recruiting
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
Name:     Jacqueline Asea
Telephone: (256) 706915390
Name:     Thomas Uldrick, MD, MS
Telephone: 206-667-7485
Name:     Thomas Uldrick, MD, MS
Affiliation:  Fred Hutchinson Cancer Research Center
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

- 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

- 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

- 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

Age minimum: 2 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Burkitt Lymphoma
Diffuse Large B-Cell Lymphoma
KSHV-associated Multicentric Castleman Disease
Biological: Rituximab
Biological: Rituximab and Hyaluronidase Human
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Doxorubicin Hydrochloride
Drug: Etoposide
Drug: Methotrexate
Drug: Prednisone
Drug: Vincristine
Primary Outcome(s)
Incidence of treatment-emergent adverse events [Time Frame: Up to 12 months]
Number of participants that result in sufficient pharmacodynamic criteria [Time Frame: Up to 12 months]
Secondary Outcome(s)
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]
Progression-free survival [Time Frame: 1 year]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Cancer Institute (NCI)
Ethics review
Results available:
Date Posted:
Date Completed:
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