A Phase 1 interventional study of Rituximab and Hyaluronidase Human and Cyclophosphamide in Burkitt Lymphoma, KSHV-associated Multicentric Castleman Disease and Diffuse Large B-Cell Lymphoma, sponsored by Fred Hutchinson Cancer Center. Terminated at 1 site in Uganda. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2024-01-03.
Sponsored by Fred Hutchinson Cancer Center · Phase 1, Interventional, and Treatment
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 combination of rituximab and hyaluronidase. Rituximab binds to a molecule called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Hyaluronidase allows rituximab to be given by injection under the skin. Giving rituximab and hyaluronidase by injection under the skin is faster than giving rituximab alone by infusion into the blood. 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. While rituximab has a clear survival benefit in patients within developed countries, differences in supportive care and infectious co-morbidities require special attention. Giving rituximab hyaluronidase alone or in combination with 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 chemotherapy alone in Uganda.
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 chemotherapy (BL or DLBCL), in 2 age-based cohorts of patients:
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.
392 studies on the registry are indexed under Burkitt Lymphoma; 114 are open to participants now.
This study's enrollment of 18 is below the median of 41 across 354 interventional studies indexed under Burkitt Lymphoma.
Browse Burkitt Lymphoma studies →Fred Hutchinson Cancer Center is the lead sponsor of 537 studies on the registry; 79 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 45 (79%) have results posted.
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Human immunodeficiency virus (HIV)-infected patients eligible if meet the following criteria:
Exclusion Criteria:
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.
Biological: Rituximab and Hyaluronidase Human · Drug: Cyclophosphamide · Drug: Vincristine · Drug: Methotrexate · Biological: Rituximab
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.
Biological: Rituximab and Hyaluronidase Human · Drug: Cyclophosphamide · Drug: Vincristine · Drug: Doxorubicin · Drug: Doxorubicin Hydrochloride · Drug: Prednisone · Drug: Etoposide · Biological: Rituximab
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.
Biological: Rituximab and Hyaluronidase Human · Drug: Cyclophosphamide · Drug: Vincristine · Drug: Doxorubicin · Drug: Doxorubicin Hydrochloride · Drug: Prednisone · Biological: Rituximab
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.
Biological: Rituximab and Hyaluronidase Human · Biological: Rituximab
Given SC
Also known as: Rituxan Hycela, Rituximab Plus Hyaluronidase, Rituximab/Hyaluronidase, Rituximab/Hyaluronidase Human
Given IV
Also known as: Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal
Given IV
Also known as: LEUROCRISTINE, VCR, Vincrystine
Given IV
Also known as: Abitrexate, Alpha-Methopterin, Amethopterin, Brimexate, Emthexat, Emtexate, Methotrexate LPF, Methylaminopterin, Methotrexatum
Given IV
Also known as: Hydroxyl Daunorubicin, Hydroxyldaunorubicin
Given IV
Also known as: Adriamycine, Adriblastina, Doxolem, Doxorubicin.HCl
Given PO
Also known as: Deltacortene, Decorton, Decortisyl, DeCortin, Deltacortisone, Econosone
Given IV
Also known as: Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Vepesid
Given IV
Also known as: BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody, CT-P10, IDEC-C2B8 Monoclonal Antibody, MabThera, Monoclonal Antibody IDEC-C2B8, Rituxan, Rituximab ABBS, Rituximab Biosimilar ABP 798, Rituximab Biosimilar BI 695500, Rituximab Biosimilar CT-P10, Rituximab Biosimilar JHL1101, Rituximab Biosimilar RTXM83, Rituximab Biosimilar SIBP-02, rituximab biosimilar TQB2303, RTXM83, Truxima
Incidence of treatment-emergent adverse events
Common Terminology Criteria for Adverse Events version 5.0 including unanticipated problems and grade 3-5 adverse events (AEs) at least probably related to subcutaneous rituximab hyaluronidase (sqR) administration.
Time frame: Up to 12 months
Number of participants that result in sufficient pharmacodynamic criteria
Pharmacodynamic criteria is a Ctrough level above 25 ug/ml in children and adolescents after the first subcutaneous dose.
Time frame: Up to 12 months
Number of participants achieving a repose of complete response (CR)
Response Evaluation Criteria in Solid Tumors (RECIST) criteria CR: complete disappearance of all target lesions.
Time frame: 1 year
Overall survival
Kaplan-Meier estimate
Time frame: 1 year
Progression-free survival
Kaplan-Meier estimate
Time frame: 1 year
Disease-free survival
Kaplan-Meier estimate
Time frame: 1 year
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