CI

At a glance

ClinicalIndex Comparison Record
Phase 1Terminated· 19 enrolled
Drug / intervention
Cytarabine +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04526795
NCT04526795Phase 1Terminated
Terminated
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Phase Ib Study of Fludarabine, Cytarabine (Ara-C) and Pegylated Erwinase (Pegcrisantaspase) in Patients with Relapsed or Refractory Leukemia

M.D. Anderson Cancer Center·interventional·Posted Aug 26, 2020·Updated Dec 12, 2024

In Brief

A Phase 1 clinical trial evaluating Cytarabine, Fludarabine, and 1 other intervention for Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive and 10 related conditions. Terminated early, enrolled 19 participants across 1 site.

Signals

Trial was terminated early

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBlast 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
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 1TerminatedFinished
202120222023202420252026
First PostedAug 26, 2020
Enrollment StartApr 9, 2021
Primary CompletionNov 15, 2024
TodayJul 1, 2026
Enrollment to primary: 3.6 yearsPosted 5.8 years ago

Interventions

Cytarabinedrug

Given IV

Fludarabinedrug

Given IV

Pegcrisantaspasedrug

Given IV