Rituximab Hyaluronidase in Combination With Chemotherapy in Treating Aggressive B-cell Lymphoma in Uganda
NCT ID: NCT03864419
Last Updated: 2024-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
18 participants
INTERVENTIONAL
2019-10-24
2023-07-26
Brief Summary
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Detailed Description
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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 chemotherapy (BL or DLBCL), in 2 age-based cohorts of patients:
1. Cohort 1: Age \>= 15
2. Cohort 2: Age: 2-14
sqR dose for Cohort 1 (adults) will be 1400 mg (flat dose); sqR dose for Cohort 2 (pediatrics) will depend on patient weight: \>= 35 kg: 1400 mg, \< 35 kg: 700 mg. For all participants, sqR will be administered with local standard of care chemotherapy (BL, DLBCL) or alone (KSHV-MCD), and supportive care.
Each cohort comprises two Therapy Groups. Therapy Group 1: up to 6 participants and will receive the first cycle of rituximab IV, and subsequent cycles as flat-dose sqR. Therapy Group 2: up to 12 participants and will receive flat-dose sqR for all cycles.
Disease-specific chemotherapy to be administered with rituximab hyaluronidase include:
PEDIATRIC BURKITT LYMPHOMA (BL): cyclophosphamide, vincristine and prednisone followed by 6 cycles of cyclophosphamide, vincristine, and methotrexate (COP-COM).
DLBCL: 6 cycles of cyclophosphamide, doxorubicin, vincristine and prednisone PO on days 1-5 of cycle 1 (CHOP).
ADULT BL: 6 cycles modified dose: etoposide, doxorubicin, vincristine, cyclophosphamide and prednisone PO on days 1-5 (adjusted EPOCH).
KSHV-MCD: Rituximab or rituximab hyaluronidase SC on days 1, 8, 15, and 22.
After completion of study treatment, patients are followed up at 30 days, 3, 6, 9 and 12 months.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort I (pediatric BL)
Patients receive cyclophosphamide IV and vincristine IV on day 1, and prednisone IV or PO on days 1-7 in the absence of disease progression or unacceptable toxicity. Patients then receive rituximab IV or rituximab hyaluronidase SC, cyclophosphamide IV, vincristine IV, and methotrexate IV on day 1. Cycles repeat every 14 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
Rituximab and Hyaluronidase Human
Given SC
Cyclophosphamide
Given IV
Vincristine
Given IV
Methotrexate
Given IV
Rituximab
Given IV
Cohort II (DLBCL)
Patients receive rituximab IV or rituximab and hyaluronidase human SC, cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1, and prednisone PO on days 1-5 of cycle 1. Cycles repeat every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
Rituximab and Hyaluronidase Human
Given SC
Cyclophosphamide
Given IV
Vincristine
Given IV
Doxorubicin
Given IV
Doxorubicin Hydrochloride
Given IV
Prednisone
Given PO
Etoposide
Given IV
Rituximab
Given IV
Cohort III (Adult BL)
Patients receive rituximab IV or rituximab and hyaluronidase human SC in day 1, etoposide IV, doxorubicin IV, and vincristine IV on days 1-4. Patients also receive cyclophosphamide IV on day 5 and prednisone PO on days 1-5. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
Rituximab and Hyaluronidase Human
Given SC
Cyclophosphamide
Given IV
Vincristine
Given IV
Doxorubicin
Given IV
Doxorubicin Hydrochloride
Given IV
Prednisone
Given PO
Rituximab
Given IV
Cohort IV (MCD)
Patients receive rituximab IV or rituximab and hyaluronidase human SC on days 1, 8, 15, and 22 in the absence of disease progression or unacceptable toxicity.
Rituximab and Hyaluronidase Human
Given SC
Rituximab
Given IV
Interventions
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Rituximab and Hyaluronidase Human
Given SC
Cyclophosphamide
Given IV
Vincristine
Given IV
Methotrexate
Given IV
Doxorubicin
Given IV
Doxorubicin Hydrochloride
Given IV
Prednisone
Given PO
Etoposide
Given IV
Rituximab
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
2 Years
ALL
No
Sponsors
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Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Manoj Menon, MD
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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UCI-Fred Hutch Cancer Centre
Kampala, , Uganda
Countries
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References
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Menon MP, Ddungu H, Mubiru KR, Adams SV, Asea J, Namagembe R, Namuli P, Kambugu J, Towlerton AMH, Puronen C, Uldrick TS, Orem J, Warren EH. Phase I Study of Subcutaneous Rituximab Hyaluronidase Combined With CHOP Chemotherapy for the Treatment of Diffuse Large B-Cell Lymphoma in Uganda. JCO Glob Oncol. 2025 Apr;11:e2400489. doi: 10.1200/GO-24-00489. Epub 2025 Apr 4.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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U028
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2019-01493
Identifier Type: REGISTRY
Identifier Source: secondary_id
10040
Identifier Type: OTHER
Identifier Source: secondary_id
RG1001799
Identifier Type: -
Identifier Source: org_study_id
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