Clinical trial · Interventional
Stem Cell Transplant to Treat Patients With Favorable or Intermediate Risk Minimal Residual Disease Negative Acute Myeloid Leukemia
Autologous Transplant as Treatment for Favorable or Intermediate Risk MRD-Negative AML Patients After Initial Induction Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI recommended closure
Summary
Brief summary (as posted)
This phase II trial studies how well autologous stem cell transplant works in treating patients with favorable or intermediate risk, minimal residual disease (MRD)-negative, acute myeloid leukemia. Giving chemotherapy before a peripheral blood stem cell transplant helps kill any cancer cells that are in the body. After treatment, stem cells are collected from the patient's blood and stored. Higher dose chemotherapy is then 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.
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 |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Minimal Residual Disease Negativity | — | UNRESOLVED | — |
Interventions
Interventions (4)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (busulfan, etoposide, ASCT)
- description
- Patients receive busulfan IV or oral every 6 hours on days -7 to -4 and etoposide IV on day -3. Patients then undergo autologous stem cell transplant on day 0.
- interventionNames
- Procedure: Autologous Hematopoietic Stem Cell Transplantation
- Drug: Busulfan
- Drug: Etoposide
- Other: Laboratory Biomarker Analysis
Primary outcomes (2)
- measure
- Relapse
- timeFrame
- Assessed up to 2 years post autologous stem cell transplant (ASCT)
- description
- Proportion of patients who relapse, as defined by 2017 National Comprehensive Cancer Network (NCCN ) Acute Myeloid Leukemia (AML) guidelines.
- measure
- Treatment related mortality
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: * AML favorable or intermediate ELN risk * Achieved true 1st complete response (CR) (absolute neutrophil count \[ANC\] and platelet count \> 1,000/ul and 100,000/ul respectively) after first cycle of induction therapy, with no minimal residual disease (MRD) * No measurable residual disease (MRD) as assessed by flow cytometry after initial induction therapy * Performance score Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2 * Creatinine \< 2.0 mg/dl and calculated by Cockcroft-Gault (CG) formula or 24 hour measured creatinine clearance (CRCL) \> 50 * Not pregnant * Received 1-2 courses of post remission "consolidation" therapy prior to mobilization PBSC * No MRD by flow, cytogenetics, fluorescence in situ hybridization (FISH) and molecular testing prior to collection of autologous PBSC collection * Plan is to collect at least 3 x 10\^6 CD34+ PBSC/kg cryopreserved; preference is 4-5 X 10\^6 CD34 cells/kg Exclusion Criteria: * Life expectancy is severely limited by diseases other than AML * Total bilirubin \> 2.0 mg/dl or serum glutamic-oxaloacetic transaminase (SGOT)/serum glutamate pyruvate transaminase (SGPT) \> 2.5 x upper limit of normal (ULN) * History of Gilbert's disease * Uncontrolled arrhythmias, left ventricular ejection fraction (LVEF) \< 50% or corrected diffusion capacity of the lung for carbon monoxide (DLCO) \< 50% * Significant active infection that precludes transplant * Hepatitis B or C viremia at time of ASCT * History of central nervous system (CNS) involvement with AML
References
Publications (0)
Data not yet available