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Clofarabine, Cyclophosphamide and Etoposide for Minimal Residual Disease Positive Acute Leukemia

NCT01677949 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-12-02

No results posted yet for this study

Summary

Study Design:

This is a two-stage Phase II trial investigating the efficacy of Clofarabine, Cyclophosphamide and Etoposide in acute leukemia patients with detectable minimal residual disease (MRD) prior to allo-HCT. The primary objective is to determine the impact of the study treatment in eliminating the presence of minimal residual disease without causing a significant delay of allo-HCT due to treatment related toxicity. The intent of this study is to allow patients to proceed to transplant (independent of this study) within 42 days of Day 1 of Clofarabine based therapy.

Conditions

Interventions

DRUG

Clofarabine

Days 1-5: Clofarabine 30 mg/m\^2 for 0-30 years of age or 20 mg/m\^2 for \> 30 years of age intravenously (IV) over 2 hours

DRUG

Etoposide

Days 1-5: Etoposide 100mg/m\^2 IV over 2 hours

DRUG

Cyclophosphamide

Days 1-5: Cyclophosphamide 300 mg/m\^2 as a 30-60 minute infusion

BIOLOGICAL

allogeneic hematopoietic cell transplantation

Between Days 28 and 42: infused independent of this study

Sponsors & Collaborators

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • Michael Burke, M.D. · Masonic Cancer Center, University of Minnesota

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT01677949 on ClinicalTrials.gov