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Phase II Study of Fludarabine, Cytarabine (ARA-C) and Erwinase IV in Patients With Relapsed or Refractory Hematologic Malignancies

NCT02718755 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2018-06-26

No results posted yet for this study

Summary

The goal of this clinical research study is to learn if fludarabine, cytarabine (ARA-C), and erwinase (also known as asparaginase \[erwinia\]) in combination can help to control relapsed or refractory hematologic malignancies. The safety of these drugs will also be studied.

Conditions

  • Hematologic Malignancy

Interventions

DRUG

Fludarabine

Induction Phase: 30 mg/m2 by vein over 15-30 minutes on Days 1 - 5 of a 28 day cycle. Consolidation Phase: 30 mg/m2 by vein over 15-30 minutes on Days 1 - 4 of a 28 day cycle.

DRUG

Cytarabine

Induction Phase: 2 grams/m2 by vein over approximately 2 hours on Days 1 - 5 of a 28 day cycle. Consolidation Phase: 2 grams/m2 by vein over approximately 2 hours on Days 1 - 4 of a 28 day cycle.

DRUG

Erwinase

Induction Phase: 25,000 Units/m2 by vein (or intramuscularly) over 90-120 minutes on Days 1 - 7 of a 28 day cycle. Consolidation Phase: 25,000 Units/m2 by vein (or intramuscularly) over 90-120 minutes every other day on Days 1, 3, 5, 7, 9, 11, 13, 15 of a 28 day cycle.

Sponsors & Collaborators

Principal Investigators

  • Tapan Kadia, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-31
Primary Completion
2021-05-31
Completion
2022-05-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02718755 on ClinicalTrials.gov