Clinical trial · Interventional
Allo BMT Using Matched Related/Unrelated Donors With FluBu and HiCY
Trial of Allogeneic BMT for Hematologic Malignancies Using HLA-matched Related or Unrelated Donors With Fludarabine and IV Busulfan as Pre-transplant Conditioning Followed by Post-transplant Immunosuppression With High-dose Cyclophosphamide
NCT00809276CI-TRIAL-00016882completedPhase 1 / Phase 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 purpose of this research is to find the most effective and least toxic way to prevent GVHD after BMT.
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 |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Busulfan, Fludarabine, Cytoxan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To Determine the Optimal Regimen of Post-graft Immunosuppression With High-dose Cy Following Fludarabine, Busulfan, and Transplantation of Fully HLA-matched Bone Marrow That Leads to an Acceptable Incidence of Grades III/IV Acute GVHD
- timeFrame
- 1 year
- description
- Percentage of participants with grade III-IV acute graft versus host disease (GVHD). GVHD is graded on a combination of skin symptoms (rash), gut symptoms (diarrhea), and liver symptoms (using a lab test called bilirubin). Grades range from I to IV, where I is the least severe and IV is the most severe.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients ages between 0 to and 65 years of age. * Patient must have a genotypically HLA-identical sibling, a phenotypically matched first-degree relative or an unrelated matched donor. * Acute lymphocytic leukemia (ALL) in CR1 with high risk features * Acute myeloid leukemia (AML) in CR1 with high risk features defined as: i. Greater than 1 cycle of induction therapy required to achieve remission, ii. Preceding myelodysplastic syndrome (MDS) other than myelofibrosis, secondary AML iii. Presence of Flt3 mutations or internal tandem duplications, iv. FAB M6 or M7 classification or adverse cytogenetics for overall survival such as those associated with MDS, M6, M7 leukemia, or v. Complex karyotype \[\> 3 abnormalities\] * Acute Leukemias in 2nd or greater remission * Refractory or Relapsed AML * AML transformed from MDS * Myelodysplastic syndrome (MDS) beyond refractory anemia * Chronic myeloid leukemia (CML) * Chronic myelomonocytic leukemia * Philadelphia-negative myeloproliferative disorder * Relapsed chemotherapy-sensitive Hodgkin's or Non-Hodgkin's lymphoma * Multiple Myeloma-Stage III Exclusion Criteria: * Prior autologous or allogeneic stem cell transplant. * Performance status greater than 2 * Active infection. * Inadequate cardiac function; arrythmias or symptomatic cardiac disease. * Inadequate pulmonary function; FEV1, FVC, DLCO \<50% of predicted * Inadequate Serum creatinine clearance \<60 * InadequatebHepatic function * Positive serology for HIV-1, 2 or HTLV-1, 2. * Pregnancy. Female patient must have negative pregnancy test
References
Publications (1)
- DERIVEDKanakry CG, O'Donnell PV, Furlong T, de Lima MJ, Wei W, Medeot M, Mielcarek M, Champlin RE, Jones RJ, Thall PF, Andersson BS, Luznik L. Multi-institutional study of post-transplantation cyclophosphamide as single-agent graft-versus-host disease prophylaxis after allogeneic bone marrow transplantation using myeloablative busulfan and fludarabine conditioning. J Clin Oncol. 2014 Nov 1;32(31):3497-505. doi: 10.1200/JCO.2013.54.0625. Epub 2014 Sep 29. PMID 25267759