Phase 2 Completed N=63 Treatment

Allogeneic Stem Cell Transplantation for Myelofibrosis and Myelodysplastic Syndrome

Myelofibrosis

Source: ClinicalTrials.gov NCT00475020 ↗

Enrolled (actual)

Serious AEs

31.0%

Results posted

Dec 2018

Primary outcomePrimary: Rate of Non-relapse Mortality at 100 Days Post-transplant — 1; 2; 1 Participants

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Rate of Non-relapse Mortality at 100 Days Post-transplant	1; 2; 1	—
SECONDARY Efficacy of This Therapy 3 Years Post-transplant	25; 27; 0; 44	—

Eligibility Criteria

Inclusion Criteria

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 /= 40%, unless cleared by cardiology
Serum direct bilirubin /= 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.

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00475020). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.