Clinical trial · Interventional
Auto BMT for Non-M3 AML in 1st Remission in Pts </=60y of Age Using Busulfan/FTBI & VP16 as a Prep R
Autologous Bone Marrow Transplantation for Non-M3 Acute Myeloid Leukemia (AML) in First Remission in Patients </=60 Years of Age Using Busulfan/Fractionated Total Body Irradiation (FTBI) and VP16 as the Preparative Regimen
- 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 before an autologous stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and/or bone marrow and stored. More chemotherapy and radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy. Giving aldesleukin after transplant may help keep cancer cells from coming back after transplant. PURPOSE: This phase II trial is studying the side effects and how well giving busulfan and etoposide together with total-body irradiation followed by autologous stem cell transplant and aldesleukin works in treating patients with acute myeloid leukemia in first remission.
Conditions
Conditions (1)
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 |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| autologous hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| bone marrow transplantation | Procedure | — | UNRESOLVED |
| busulfan | Drug | Busulfan | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| idarubicin | Drug | Idarubicin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HD ARA-C with or without Idarubicin
- description
- This study was designed as a single-arm study. Strata were: HD ARA-C w/ Idarubicin, CR\<6 months N = 24 patients. HD ARA-C w/ Idarubicin, CR\>6 months N=1. HD ARA-C consolidation, CR\<6 months N=5. HD ARA-C consolidation, CR\>6 months N= 0.
- interventionNames
- Biological: aldesleukin
- Biological: filgrastim
- Drug: busulfan
- Drug: cytarabine
- Drug: etoposide
- Drug: idarubicin
- Procedure: autologous hematopoietic stem cell transplantation
- Procedure: bone marrow transplantation
- Procedure: peripheral blood stem cell transplantation
- Radiation: total-body irradiation
Primary outcomes (1)
- measure
- Disease-Free Survival at 2-Year Post-Transplant
- timeFrame
- Estimate at 2 years post treatment
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 60 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of acute myeloid leukemia (AML)
* FAB types M0-2 and M4-M7
* No M3 disease
* In first complete hematological remission as confirmed by marrow aspiration and biopsy
* No cytogenetic abnormality in the remission marrow
* In complete remission for less than 6 months
* Patients who have been in complete remission for more than 6 months may be eligible upon approval of the principal investigator
* No prior myeloproliferative disorder (e.g., chronic myeloid leukemia, myelofibrosis, essential thrombocytosis, or polycythemia vera)
* No prior myelodysplasia or secondary leukemia
PATIENT CHARACTERISTICS:
* FEV\_1 \> 60%
* DLCO \> 50%
* Cardiac ejection fraction ≥ 50%
* Creatinine clearance \> 60 mL/min
* No severe chronic medical or psychological illness that, in the judgement of the principal investigator, would jeopardize the ability of the patient to tolerate aggressive chemotherapy
* No HIV positivity
* Not pregnant
* Negative pregnancy test
PRIOR CONCURRENT THERAPY:
* Prior consolidation therapy allowed
* No concurrent use the following medications during aldesleukin therapy :
* Corticosteroids (including blood product "pre-meds")
* Pentoxifylline
* IV or intrathecal methotrexate
* IV immunoglobulin
* Other cytokines or growth factorsReferences
Publications (0)
Data not yet available