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

CompletedPhase 1, Phase 2

Sponsor: M.D. Anderson Cancer Center

Conditions: Stem Cell Transplantation, Leukemia

Interventions: Plerixafor, Filgrastim, Fludarabine, Busulfan, Allogeneic blood stem cell transplant

Countries: United States

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Patients age \>/=18 to \</= 65 years.
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) \</= 20 \* 10\^9/l.
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 \</=1.5 mg/dl.
9. Serum glutamic pyruvic transaminase (SGPT) \</= 200 IU/ml unless related to the malignancy.
10. Total serum bilirubin \</=1.5 mg/dl (unless Gilbert's syndrome) and alkaline phosphatase \</=2.5 times laboratory standard upper limit of normal (ULN).
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).

Locations (1)

Houston, Texas, United States