NCT04526795

Fludarabine, Cytarabine, and Pegcrisantaspase for the Treament of Relapsed or Refractory Leukemia

Phase Ib Study of Fludarabine, Cytarabine (Ara-C) and Pegylated Erwinase (Pegcrisantaspase) in Patients with Relapsed or Refractory Leukemia

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This phase Ib trial investigates the side effects and best dose of pegcrisantaspase when given together with fludarabine and cytarabine for the treatment of patients with leukemia that has come back (relapsed) or has not responded to treatment (refractory). Pegcrisantaspase may block the growth of cancer cells. Chemotherapy drugs, such as fludarabine and cytarabine, 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 pegcrisantaspase in combination with fludarabine and cytarabine may work better in treating patients with leukemia compared to the combination of fludarabine and cytarabine.

Detailed description

PRIMARY OBJECTIVE: I. To determine the safety and tolerability of fludarabine, cytarabine (araC), and pegcrisantaspase in patients with relapsed and refractory leukemias. SECONDARY OBJECTIVES: I. To determine the overall response rate (complete remission \[CR\], CR with incomplete count recovery \[CRi\], partial remission \[PR\], or morphologic leukemia free state \[MLFS\]) of a lead-in dose of single-agent pegcrisantaspase in patients with relapsed and refractory leukemias. II. To determine the overall response rate (complete remission \[CR\], CR with incomplete count recovery \[CRi\], partial remission \[PR\], or morphologic leukemia free state \[MLFS\]) of fludarabine, araC, and pegcrisantaspase in patients with relapsed and refractory leukemias. III. To assess overall survival (OS) and disease-free survival (DFS) of patients treated with fludarabine, araC, and pegcrisantaspase. IV. To assess the duration of response to the combination in patients with advanced leukemias. V. To characterize the pharmacokinetics (PK) pharmacodynamics (PD) anti-drug antibodies (ADA) of pegcrisantaspase in patients with relapsed and refractory leukemias. EXPLORATORY OBJECTIVE: I. Explore pretreatment and on-treatment biological correlates to predict sensitivity/resistance of pegcrisantaspase-based therapy. OUTLINE: This is a dose-escalation study of pegcrisantaspase. INDUCTION: Patients receive pegcrisantaspase intravenously (IV) over 60 minutes on days 1 and 15, and fludarabine IV over 15-30 minutes and cytarabine IV over 2 hours on days 8-11 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive pegcrisantaspase IV over 60 minutes on days 1 and 15, and fludarabine IV over 15-30 minutes and cytarabine IV over 2 hours on days 8-10. Treatment repeats every 5 weeks for up 3 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6-12 months.

Conditions

• Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Recurrent Acute Biphenotypic Leukemia
• Recurrent Acute Lymphoblastic Leukemia
• Recurrent Acute Myeloid Leukemia
• Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Recurrent T-Cell Prolymphocytic Leukemia
• Refractory Acute Biphenotypic Leukemia
• Refractory Acute Lymphoblastic Leukemia
• Refractory Acute Myeloid Leukemia
• Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Refractory T-Cell Prolymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	Cytarabine	Given IV
DRUG	Fludarabine	Given IV
DRUG	Pegcrisantaspase	Given IV

Timeline

• Start date: 2021-04-09
• Primary completion: 2024-11-15
• Completion: 2024-11-15
• First posted: 2020-08-26
• Last updated: 2024-12-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study