Phase 2
N=63
Allogeneic Stem Cell Transplantation for Myelofibrosis and Myelodysplastic Syndrome
Myelofibrosis
Bottom Line
View on ClinicalTrials.gov: NCT00475020 ↗Enrolled (actual)
63
Serious AEs
31.0%
Results posted
Dec 2018
Primary outcome: Primary: Rate of Non-relapse Mortality at 100 Days Post-transplant — 1; 2; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Busulfan (Drug); Fludarabine (Drug); Thymoglobulin (ATG) (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Oct 2017
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 | — |
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.
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
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.