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Plerixafor and Clofarabine in Frontline Treatment of Elderly Patients With Acute Myelogenous Leukemia (AML)

NCT01160354 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2019-08-28

Study results available
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Summary

The goal of Part 1 of this clinical research study is to learn about the safety of the combination of plerixafor and clofarabine when given to patients with previously untreated AML who are at least 60 years old.

The goal of Part 2 of this study is to learn if the combination of plerixafor and clofarabine can help to control previously untreated AML in patients who are at least 60 years old. Study was closed early and did not progress to Part 2.

Conditions

  • Acute Myelogenous Leukemia

Interventions

DRUG

Plerixafor

Starting at 240 mcg/kg daily subcutaneous (SQ) injection on Days 1-5, 4-6 hours before a 1 hour (+/- 30 minutes) IV administration of Clofarabine

DRUG

Clofarabine

Fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Jan A. Burger, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • United States

Study Locations

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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 NCT01160354 on ClinicalTrials.gov