Clinical trial · Interventional
Busulfan and Fludarabine Followed by Post-transplant Cyclophosphamide
Busulfan (IV) and Fludarabine Followed by Post-allogeneic Transplantation Cyclophosphamide for Graft-versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies.
- 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 cyclophosphamide given after busulfan and fludarabine can help to prevent graft versus host disease (GVHD - a condition in which transplanted tissue attacks the body into which it is transplanted) in patients receiving a stem cell transplant. The safety of this drug combination will also be studied.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Diseases | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Busulfan | Drug | Busulfan | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Busulfan + Fludarabine + Cyclophosphamide
- description
- Busulfan starting dose of 32 mg/m\^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m\^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
- interventionNames
- Drug: Busulfan
- Drug: Fludarabine
- Drug: Cyclophosphamide
Primary outcomes (3)
- measure
- Cumulative Incidence of Grade II to IV Acute GVHD
- timeFrame
- 100 days post transplant
- description
- Graft Versus Host Disease (GVHD) defined as grade 2 to 4 GVHD within first 100 days post transplant. Death or disease progression before diagnosis of GVHD were considered competing risks in the estimation of the incidence of acute GVHD.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Months
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with high risk hematological malignancies, including those with induction failure and after treated or untreated relapse. 2. HLA-identical sibling or matched unrelated donor transplants not eligible for protocols of higher priority. 3. Age 6 months to 75 years. 4. Bilirubin \</= 1.5 mg/dl, serum glutamate pyruvate transaminase (SGPT) \</= 200 IU/ml (unless Gilbert's syndrome). 5. Calculated creatinine clearance of \>50mL/min using the Cockcroft-Gault equation for adult patients 18 to 70 years old, and the Schwartz equation for pediatric patients 6 months to 17 years old. 6. Diffusing capacity for carbon monoxide (DLCO) \>45% predicted corrected for hemoglobin (as reported by the Pulmonary Function Laboratory at MDACC). For most children \</= 6 years of age who are unable to perform pulmonary function test (PFT), pulse oximetry \>/= 92% on room air. 7. left ventricular ejection fraction (LVEF) \>/= 35%. Exclusion Criteria: 1. HIV seropositivity 2. Uncontrolled infections. 3. 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 4. Inability to sign consent
References
Publications (0)
Data not yet available