Clinical trial · Interventional
Busulfan, Etoposide, and Total-Body Irradiation in Treating Patients Undergoing Donor Stem Cell or Bone Marrow Transplant for Advanced Hematologic Cancer
Phase II Study of IV Busulfan Combined With 12 cGy of Fractionated Total Body Irradiation (FTBI) and Etoposide (VP-16) as a Preparative Regimen for Allogeneic Bone Marrow Transplantation for Patients With Advanced Hematological 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)
RATIONALE: Giving chemotherapy and total-body irradiation before a donor stem cell transplant or a donor bone marrow transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving mycophenolate mofetil and cyclosporine before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying the side effects and best way to give busulfan together with etoposide and total-body irradiation and to see how well they work in treating patients who are undergoing a donor stem cell or bone marrow transplant for advanced hematologic cancer.
Conditions
Conditions (2)
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 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic bone marrow transplantation | Procedure | — | UNRESOLVED |
| allogeneic hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| busulfan | Drug | Busulfan | ALIAS |
| cyclosporine | Drug | — | UNRESOLVED |
| etoposide | Drug | Etoposide | ALIAS |
| mycophenolate mofetil | Drug | — | UNRESOLVED |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| total-body irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Busulfan, FTBI and VP16
- description
- IV Busulfan + 12 cGy FTBI + VP16 prior to allogeneic Bone Marrow Transplant
- interventionNames
- Drug: busulfan
- Drug: cyclosporine
- Drug: etoposide
- Drug: mycophenolate mofetil
- Procedure: allogeneic bone marrow transplantation
- Procedure: allogeneic hematopoietic stem cell transplantation
- Procedure: peripheral blood stem cell transplantation
- Radiation: total-body irradiation
Primary outcomes (4)
- measure
- Overall Survival at 5 Years Post-Transplant.
- timeFrame
- Date of Transplant to Five Years post-Transplant
- description
- Kaplan-Meier estimate of an event of death estimated at five years post-transplant. 95% confidence intervals were calculated from the logit transform of the Greenwood variance. The transformation was necessary to keep the estimate within the probability space of 0 to 100%.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 50 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of 1 of the following:
* Acute myeloid leukemia (AML)
* Failed remission induction therapy or in relapse beyond second remission
* In first remission with poor risk cytogenetics (e.g., 11q abnormalities, -7, -5, complex abnormalities \[i.e., \> 3 abnormalities, 6;9 translocation and 3q abnormalities del (7q), del (5q), complex abnormalities ≥ abnormalities, 9q, 20q, 21q, 17q, t(9;21)\])
* Acute lymphoblastic leukemia (ALL)
* Failed remission induction therapy or in relapse beyond second remission
* Blastic phase chronic myelogenous leukemia
* Refractory anemia with excess blasts
* Refractory anemia with excess blasts in transformation
* HLA -A, -B, -C, -DR identical sibling donor match available
* No relapse after prior bone marrow transplantation
PATIENT CHARACTERISTICS:
* Cardiac ejection fraction ≥ 50%
* Serum creatinine ≤ 1.2 times upper limit of normal (ULN) or creatinine clearance \> 80 mL/min
* Bilirubin ≤ 1.5 times ULN
* AST and ALT \< 5 times ULN
* FEV\_1 ≥ 50% of predicted normal
* DLCO ≥ 50% of predicted normal
* No psychological or medical condition that would preclude allogeneic transplantation (in the opinion of the treating physician)
* Not pregnant
* Negative pregnancy test
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 28 days since prior induction or reinduction therapy
* Prior etoposide and busulfan allowed
* No prior radiation therapy that would exclude total-body irradiationReferences
Publications (0)
Data not yet available