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Plerixafor and Granulocyte Colony-stimulating Factor (G-CSF) With Busulfan, Fludarabine and Thymoglobulin

NCT00822770 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2020-10-14

Study results available
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Summary

The goal of this clinical research study is to learn about the safety of AMD3100 (plerixafor) and G-CSF (filgrastim) in combination with fludarabine, busulfan, and an allogeneic blood stem cell transplant. This treatment will be studied in patients with acute myeloblastic leukemia (AML), myelodysplastic syndromes (MDS), or Chronic myelogenous leukemia (CML).

Conditions

Interventions

DRUG

Plerixafor

Phase I: Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses. Phase II: Maximum Tolerated Dose (MTD) as determined in Phase I

DRUG

Filgrastim

Dose of 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days.

DRUG

Fludarabine

Dose of 40 mg/m\^2 beginning on Day -6 for four consecutive days.

DRUG

Busulfan

Dose of 130 mg/m\^2 for four consecutive days, immediately after completion of Fludarabine.

PROCEDURE

Allogeneic blood stem cell transplant

Stem Cell Infusion (Bone marrow or PBPC)

DRUG

ATG (Thymoglobulin)

Dose(s) of 0.5 mg/kg on day -3; of 1.5 mg/kg on day -2; and of 2 mg/kg on day -1. Given only to patients with unrelated donors.

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Marina Konopleva, MD, PhD · UT MD Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2012-10-31
Completion
2012-10-31

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 NCT00822770 on ClinicalTrials.gov