Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2025-12-30 @ 6:01 PM
Study NCT ID:
NCT04526795
Status:
TERMINATED
Last Update Posted:
2024-12-12
First Post:
2020-08-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fludarabine, Cytarabine, and Pegcrisantaspase for the Treament of Relapsed or Refractory Leukemia
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Phase Ib Study of Fludarabine, Cytarabine (Ara-C) and Pegylated Erwinase (Pegcrisantaspase) in Patients with Relapsed or Refractory Leukemia
Status:
TERMINATED
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively Complete
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: