NCT02293109

Carfilzomib and Hyper-CVAD in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoma

Phase I Study of Escalating Doses of Carfilzomib With Hyper-CVAD in Patients With Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Mehrdad Abedi, MD · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of carfilzomib when given together with the hyperfractionated (hyper)-cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, and dexamethasone (CVAD) chemotherapy regimen in treating patients with newly diagnosed acute lymphoblastic leukemia or lymphoma. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving carfilzomib with combination chemotherapy may kill more cancer cells.

Detailed description

PRIMARY OBJECTIVES: I. Safety and tolerability of administering carfilzomib in combination with hyper-CVAD chemotherapy. II. Recommended dose of carfilzomib in combination with hyper-CVAD chemotherapy for the future phase II trial. SECONDARY OBJECTIVES: I. Rate of remission after 2nd and 4th cycles. II. Incidence of minimal residual disease by flow cytometry at 4th cycle. OUTLINE: This is a dose escalation study of carfilzomib. Patients receive carfilzomib intravenously (IV) over 30 minutes on days 0, 1, 7, and 8. Patients also receive hyper-CVAD comprising cyclophosphamide IV over 2 hours every 12 hours for 6 doses beginning on day 1, vincristine sulfate IV on days 4 and 11, doxorubicin hydrochloride IV over 2-24 hours on day 4, and dexamethasone orally (PO) on days 1-4 and 11-14 (courses 1 and 3) and methotrexate IV over 24 hours on day 1, cytarabine IV over 2 hours every 12 hours for 4 doses starting on day 2, leucovorin calcium IV or PO every 6 hours beginning 36 hours after the start of methotrexate infusion, and methylprednisolone IV every 12 hours for 6 doses beginning on day 1 (courses 2 and 4). Patients with cluster of differentiation (CD)20 positive disease also receive rituximab twice daily on days 1 and 11 of courses 1 and 3 and days 1 and 8 of courses 2 and 4. Treatment repeats every 3-4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 28 days.

Conditions

• Contiguous Stage II Adult Lymphoblastic Lymphoma
• Noncontiguous Stage II Adult Lymphoblastic Lymphoma
• Stage I Adult Lymphoblastic Lymphoma
• Stage III Adult Lymphoblastic Lymphoma
• Stage IV Adult Lymphoblastic Lymphoma
• Untreated Adult Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	carfilzomib	Given IV
DRUG	cyclophosphamide	Given IV
DRUG	vincristine sulfate	Given IV
DRUG	doxorubicin hydrochloride	Given IV
DRUG	dexamethasone	Given PO
DRUG	methotrexate	Given IV
DRUG	cytarabine	Given IV
DRUG	leucovorin calcium	Given IV or PO
DRUG	methylprednisolone	Given IV
BIOLOGICAL	rituximab
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2015-12-17
• Primary completion: 2017-12-13
• Completion: 2018-01-11
• First posted: 2014-11-18
• Last updated: 2022-03-10

Locations

1 site across 1 country: United States