Clinical trial · Interventional
Stem Cell Transplantation for Hematological Malignancies
Busulfan, Cyclophosphamide, and Melphalan Followed by Allogeneic Hematopoietic Cell Transplantation in Patients With Hematological Malignancies
NCT00176839CI-TRIAL-00030675terminatedPhase 2 / Phase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Replaced by a different study
Summary
Brief summary (as posted)
This protocol using busulfan, cyclophosphamide and melphalan has been designed as conditioning therapy for patients receiving stem cell transplantation for acute leukemia or myelodysplastic syndrome (MDS). The hypothesis is that this new regimen will be well tolerated and will cure the patient.
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 |
|---|---|---|---|
| AML | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Leukemia, Lymphocytic, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
| MDS | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ATG | Drug | — | UNRESOLVED |
| Busulfan | Drug | Busulfan | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| G-CSF | Drug | — | UNRESOLVED |
| Melphalan | Drug | Melphalan | ALIAS |
| Stem Cell Transplant | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment Arm
- description
- Patients treated with therapy plan consisting of Busulfan every 6 hours on days -7 through -4, Cyclophosphamide 60 mg/kg/day IV x 2 days, Melphalan 140 mg/m on day -1, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation on day 0.
- interventionNames
- Procedure: Stem Cell Transplant
- Drug: Busulfan
- Drug: Cyclophosphamide
- Drug: Melphalan
- Drug: G-CSF
- Drug: ATG
Primary outcomes (1)
- measure
- Probability of Long-term Disease-free Survival (DFS)
- timeFrame
- 1 year
- description
- Number of participants with long-term disease free survival after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have a diagnosis of acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) and currently be in complete remission. * Patients must be either: * \- \<18 years of age who are at least 6 months after initial hematopoietic cell transplant (HCT), * \- 19-35 years of age and at least 18 months after initial HCT, or * \- \<35 years of age and have received sufficient radiation treatment to be ineligible for total body irradiation (TBI) containing preparative therapy * Adequate major organ function including: * \- Cardiac: ejection fraction \> or = 45% * \- Renal: creatinine clearance \> or = 40 mL/min * \- Hepatic: no clinical evidence of hepatic failure (e.g. coagulopathy, ascites) * \- Karnofsky performance status \> or = 70% or Lansky score \> or = 50% * Women of child bearing age must be using adequate birth control and have a negative pregnancy test. * Written informed consent. Exclusion Criteria: * Eligible for TBI containing preparative regimen. * Active uncontrolled infection within one week of HCT. * Pregnant or lactating females.
References
Publications (0)
Data not yet available
No reference posted for this study.