Overview

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

Status:
Completed
Trial end date:
2012-10-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Genzyme, a Sanofi Company
Treatments:
Antilymphocyte Serum
Busulfan
Fludarabine
Fludarabine phosphate
JM 3100
Lenograstim
Plerixafor
Thymoglobulin
Vidarabine
Criteria
Inclusion Criteria:

1. Patients age >/=18 to
2. Diagnosis of AML in first or greater remission, first or subsequent relapse, or
primary induction failure; MDS with intermediate or high risk International Prognostic
Scoring System (IPSS) score having failed to respond or recurred after chemotherapy;
in remission or having active disease after treatment; AML arising from MDS; or CML
which has failed to respond to imatinib or other tyrosine kinase inhibitor and has had
>5% blasts in the blood or bone marrow. Patients receiving second transplants after
relapse are considered in the relapse group.

3. White Blood Count (CBC)
4. Patients should have a histocompatible, related or unrelated volunteer donor
available. A histocompatible donor is defined as HLA matched related donor or an
unrelated donor matched for HLA- A, B, C, and DR antigens by high-resolution DNA
techniques.

5. Zubrod performance status 0 or 1, or Karnofsky performance status 90-100%.

6. Left ventricular ejection fraction >/= 45 %. No uncontrolled arrhythmias or
uncontrolled symptomatic cardiac disease.

7. No symptomatic pulmonary disease. Forced expiratory volume in 1 s (FEV1), forced vital
capacity (FVC) and diffusion capacity of carbon monoxide (DLCO) >/= 50 % of expected,
corrected for hemoglobin.

8. Serum creatinine
9. Serum glutamic pyruvic transaminase (SGPT) malignancy.

10. Total serum bilirubin phosphatase
11. Patient or patient's legal representative able to sign informed consent.

Exclusion Criteria:

1. History of HIV positive.

2. Positive Beta human chorionic gonadotropin (HCG) test in a woman with child bearing
potential defined as not post-menopausal for 12 months or no previous surgical
sterilization.

3. Pleural/pericardial effusion or ascites estimated >/= 1 liter.

4. Uncontrolled infection, not responding to appropriate antimicrobial agents after seven
days of therapy.

5. History of acute hepatitis, chronic active hepatitis or cirrhosis.

6. Patients with class 3 or 4 angina (New York Heart Association (NYHA) criteria).