Allogeneic Stem Cell Transplantation for Myelofibrosis and Myelodysplastic Syndrome

Completed · Phase 2

Conditions studied: Myelofibrosis

In brief

The goal of this clinical research study is to learn if using a combination of fludarabine, busulfan, and antithymocyte globulin (ATG) can help to control myelofibrosis or myelodysplastic syndrome in patients receiving a bone marrow or blood stem cell transplant. The safety of these drugs will also be studied.

Key facts

Study ID

NCT00475020

Run by

M.D. Anderson Cancer Center

People needed

63

Starts

2006-01-04

Expected to finish

2017-10-04

Last updated by the study team

2019-05-21

Who can join

Age: any, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with Idiopathic Myelofibrosis or Myelofibrosis secondary to Polycythemia Vera or Essential Thrombocythemia or Myelodysplastic syndrome with or without fibrosis.
• Patients 75 years or younger
• Patients must have an HLA matched or at least a 9/10 antigen (A, B, C, DQ or DR) matched related or unrelated donor.
• Patients must have a Zubrod PS 2 or less.
• Creatinine < 1.6 mg/dl
• Ejection fraction >/= 40%, unless cleared by cardiology
• Serum direct bilirubin < 2 mg/dl (unless due to Gilbert's syndrome), serum glutamate pyruvate transaminase (SGPT) </= 4 x normal values
• Forced expiratory volume at one second (FEV1), forced vital capacity (FVC), or diffusing capacity of lung for carbon monoxide (DLCO) >/= 40% of expected.
• Negative 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.

You may not qualify if…

• Uncontrolled life-threatening infections
• HIV positive
• Patients with Active viral hepatitis

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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