Rituximab Hyaluronidase and Combination Chemotherapy in Treating Aggressive B-cell Lymphoma in Uganda
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Lymphoma, Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 2 - Any |
| Updated: | 3/27/2019 |
| Start Date: | May 4, 2019 |
| End Date: | May 4, 2023 |
| Contact: | Thomas Uldrick |
| Email: | tuldrick@fredhutch.org |
| Phone: | 206-667-7485 |
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 Children, Adolescents, and Adults in Uganda
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 herpesvirus associated multicentric Castleman disease. Rituximab hyaluronidase
is a monoclonal antibody, called rituximab, linked to a substance called hyaluronidase.
Immunotherapy with monoclonal antibodies, such as rituximab, may help the body's immune
system attack the cancer, and may interfere with the ability of tumor cells to grow and
spread. Hyaluronidase may help deliver rituximab into the body faster than giving rituximab
alone. Drugs used in chemotherapy, such as cyclophosphamide, vincristine, methotrexate,
etoposide, doxorubicin, and prednisone work in different ways to stop the growth of tumor
cells, either by killing the cells, by stopping them from dividing, or by stopping them from
spreading. Giving rituximab hyaluronidase and combination chemotherapy may work better in
treating patients with Burkitt lymphoma, diffuse large B-cell lymphoma, or Kaposi sarcoma
herpesvirus associated multicentric Castleman disease compared to combination chemotherapy
alone.
in treating patients in Uganda with Burkitt lymphoma, diffuse large B-cell lymphoma, or
Kaposi sarcoma herpesvirus associated multicentric Castleman disease. Rituximab hyaluronidase
is a monoclonal antibody, called rituximab, linked to a substance called hyaluronidase.
Immunotherapy with monoclonal antibodies, such as rituximab, may help the body's immune
system attack the cancer, and may interfere with the ability of tumor cells to grow and
spread. Hyaluronidase may help deliver rituximab into the body faster than giving rituximab
alone. Drugs used in chemotherapy, such as cyclophosphamide, vincristine, methotrexate,
etoposide, doxorubicin, and prednisone work in different ways to stop the growth of tumor
cells, either by killing the cells, by stopping them from dividing, or by stopping them from
spreading. Giving rituximab hyaluronidase and combination chemotherapy may work better in
treating patients with Burkitt lymphoma, diffuse large B-cell lymphoma, or Kaposi sarcoma
herpesvirus associated multicentric Castleman disease compared to combination chemotherapy
alone.
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
- 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)
- 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
- 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)
We found this trial at
1
site
Seattle, Washington 98109
Principal Investigator: Thomas Uldrick
Phone: 206-667-7485
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