Clinical trial · Interventional
Allogeneic Stem Cell Transplantation for Myelofibrosis and Myelodysplastic Syndrome
Allogeneic Stem Cell Transplantation for Myelofibrosis and Myelodysplastic Syndrome Using Reduced Intensity Busulfan and Fludarabine Conditioning
NCT00475020CI-TRIAL-00038738completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myelofibrosis | Primary Myelofibrosis | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Busulfan | Drug | Busulfan | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Thymoglobulin (ATG) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fludarabine + Busulfan + Thymoglobulin
- description
- Fludarabine 40 mg/m\^2 by vein daily over 1 hour x 4 days. Busulfan test dose = 32 mg/m\^2 by vein x 1 day; 100 mg/m\^2 by vein daily over 3 hours x 4 days. Thymoglobulin 2.5 mg/kg by vein over 6 hours x 3 days if there is an unrelated or a mismatched donor.
- interventionNames
- Drug: Busulfan
- Drug: Fludarabine
- Drug: Thymoglobulin (ATG)
Primary outcomes (1)
- measure
- Rate of Non-relapse Mortality at 100 Days Post-transplant
- timeFrame
- Non-relapse mortality at 100 days post-transplant
- description
- To evaluate the safety of Fludarabine/Busulfan as conditioned regimen for allogeneic stem cell transplantation in patients with myelofibrosis/myelodysplastic syndrome at 100 days post-transplant
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with Idiopathic Myelofibrosis or Myelofibrosis secondary to Polycythemia Vera or Essential Thrombocythemia or Myelodysplastic syndrome with or without fibrosis. 2. Patients 75 years or younger 3. Patients must have an HLA matched or at least a 9/10 antigen (A, B, C, DQ or DR) matched related or unrelated donor. 4. Patients must have a Zubrod PS 2 or less. 5. Creatinine \< 1.6 mg/dl 6. Ejection fraction \>/= 40%, unless cleared by cardiology 7. Serum direct bilirubin \< 2 mg/dl (unless due to Gilbert's syndrome), serum glutamate pyruvate transaminase (SGPT) \</= 4 x normal values 8. Forced expiratory volume at one second (FEV1), forced vital capacity (FVC), or diffusing capacity of lung for carbon monoxide (DLCO) \>/= 40% of expected. 9. 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: 1. Uncontrolled life-threatening infections 2. HIV positive 3. Patients with Active viral hepatitis
References
Publications (0)
Data not yet available
No reference posted for this study.