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Bridging Study to Eliminate Presence of MRD for Acute Leukemia Before HCT

NCT02349178 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2020-03-09

Study results available
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Summary

This is a Phase 2 study designed for the purpose of estimating various parameters surrounding the efficacy of Clofarabine, Cyclophosphamide and Etoposide in eliminating minimal residual disease (MRD) in acute leukemia patients otherwise in remission and without causing significant delay of HCT due to treatment related toxicity.

A single course of "bridge" chemotherapy is given prior to the transplant procedure as an approach to improved disease-free survival in a patient group who historically has had inferior outcomes.

Conditions

Interventions

DRUG

Clofarabine

Days 1-5 receive Clofarabine 20 mg/m2 IV over 2 hours

DRUG

Cyclophosphamide

Days 1-5 receive Cyclophosphamide 300 mg/m2 IV as a 30-60 minute infusion

DRUG

Etoposide

Days 1-5 receive Etoposide 100 mg/m2 IV over 2 hours

Sponsors & Collaborators

  • American Family Children's Hospital

    collaborator OTHER

  • Nationwide Children's Hospital

    collaborator OTHER

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Michael J Burke, MD · Medical College of Wisconsin

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
39 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-08
Primary Completion
2017-03-16
Completion
2017-03-16

Countries

  • United States

Study Locations

More Related Trials

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 NCT02349178 on ClinicalTrials.gov