Clinical trial · Interventional
Feasibility and Efficacy Study of Conditioning Regimen for Allogeneic Hematopoietic Cell Transplantation (HCT) With Fludarabine, Busulfan, and Total Body Irradiation (TBI)
Prospective Phase II Clinical Trial of Myeloablative Conditioning Regimen With Fludarabine and Busulfan Plus 400 cGy Total Body Irradiation for Hematologic Malignancies
NCT00815568CI-TRIAL-00001856unknownPhase 2ClinicalTrials.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 purpose of this study is to evaluate the OS, RFS, and TRM after HCT with low-dose total body irradiation, fludarabine, and busulfan conditioning.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ALL | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| AML | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| CML | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| MDS | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fludarabine phosphate, busulfan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Regimen
- description
- Conditioning regimen for AML with FLT3 mutation, AML/MDS unfavorable cytogenetic risk group, chemorefractory NHL or HD, or ALL/CML
- interventionNames
- Drug: fludarabine phosphate, busulfan
Primary outcomes (1)
- measure
- progression free survival
- timeFrame
- one year
Secondary outcomes (1)
- measure
- relapse of primary disease, overall survival, and occurrence of acute/chronic GVHD
- timeFrame
- one year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * At least 15 years old and not more than 65 years old. * ECOG performance status 0-2. * Patients with AML or MDS with intermediate/unfavorable cytogenetics. * Patients with ALL and CML ineligible for Cy/TBI conditioning. * Patients with NHL or HD eligible to myeloablative HCT. * Patients receiving unrelated BMT for AML, MDS, ALL, CML, NHL or HD. * Consent form signed and dated prior to study specific procedures. * Subject able to comply with the scheduled follow-up and with the management of toxicities. Exclusion Criteria: \-
References
Publications (0)
Data not yet available
No reference posted for this study.