Clinical trial · Interventional
Busulfan and Cyclophosphamide Followed By ALLO BMT
Busulfan and Cyclophosphamide Followed By Allogeneic Hematopoietic Cell Transplantation In Patients With Hematological Malignancies
NCT01685411CI-TRIAL-00051226terminatedN/AResults 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)
This is a treatment guideline to allow routine clinical data to be collected and maintained in Oncore (clinical database) and the University of Minnesota Blood and Marrow Database as part of the historical database maintained by the department.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogeneic hematopoietic stem cell transplant | Biological | — | UNRESOLVED |
| Allopurinol | Drug | — | UNRESOLVED |
| antithymocyte globulin | Biological | — | UNRESOLVED |
| Busulfan | Drug | Busulfan | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Filgrastim | Biological | Filgrastim | ALIAS |
| Keppra | Drug | — | UNRESOLVED |
| Mycophenolate mofetil | Drug | — | UNRESOLVED |
| Tacrolimus |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Allogeneic Hematopoietic Stem Cell Transplant
- description
- Patients treated with Allopurinol, Keppra, Busulfan, Cyclophosphamide, Filgrastim, antithymocyte globulin, Tacrolimus, Mycophenolate mofetil and allogeneic hematopoietic stem cell transplant infusion.
- interventionNames
- Drug: Allopurinol
- Drug: Keppra
- Drug: Busulfan
- Drug: Cyclophosphamide
- Drug: Tacrolimus
- Drug: Mycophenolate mofetil
- Biological: Allogeneic hematopoietic stem cell transplant
- Biological: Filgrastim
- Biological: antithymocyte globulin
Primary outcomes (3)
- measure
- Counts of Participants With Disease Free Survival
- timeFrame
- 2 Years
- description
- The length of time after treatment ends that a patient survives without any signs or symptoms of that cancer or any other type of cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works. Patients with leukemia involving the BM and myelodysplastic syndrome will have this assessed by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients will also have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 44 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) and current in complete remission meeting one of the following: * \<45 years of age who are at least 6 months after initial hematopoietic stem cell transplant (HSCT) * \<45 years of age and have received sufficient radiation treatment to be ineligible for total body irradiation (TBI) containing preparative therapy * Karnofsky performance status \>70% or if \<16 years of age, a Lansky play score \>50 * Adequate major organ function including: * cardiac: left ventricular ejection fraction \>45% by echocardiogram (ECHO/MUGA) * renal: creatinine clearance \>40 mL/min/1.73m\^2 * hepatic: no clinical evidence of hepatic failure (e.g., coagulopathy, ascites) * An acceptable source of stem cells according to current University of Minnesota Bone Marrow Transplant program guidelines. Acceptable stem cell sources include: * HLA-matched related or unrelated donor bone marrow (6/6 or 5/6 antigen match) * HLA-matched related or unrelated donor peripheral blood stem cells * related or single or double unrelated donor umbilical cord blood (6/6, 5/6 or 4/6 match) * Women of childbearing age must have a negative pregnancy test and all sexually active participants must agree to use effective contraception during study treatment * Written consent (adult or parent/guardian) Exclusion Criteria: * eligible for TBI containing preparative regimen * active uncontrolled infection within one week of study enrollment * pregnant or lactating female
References
Publications (0)
Data not yet available
No reference posted for this study.