Clinical trial · Interventional
Consolidation Therapy for Acute Myeloid Leukemia Guided by Leukemia Stem Cell Behavior
NCT01588951CI-TRIAL-00034337terminatedPhase 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): Low accrual
Summary
Brief summary (as posted)
The primary objective of the trial is to compare the two-year relapse-free survival (RFS) of patients with acute myeloid leukemia (AML), presumed to be at high risk for relapse due to the presence of leukemia stem cells (LSCs) in their bone marrow at first complete remission (CR1), who receive either standard cytarabine-based chemotherapy or allogeneic stem cell transplantation (SCT).
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 |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogeneic transplant | Drug | — | UNRESOLVED |
| Cytarabine consolidation | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- No Leukemia Stem Cells - Consolidation
- description
- Without LSC, standard cytarabine consolidation
- interventionNames
- Drug: Cytarabine consolidation
- type
- EXPERIMENTAL
- label
- Leukemia Stem Cells - Consolidation
- description
- LSC present, randomized to cytarabine consolidation
- interventionNames
- Drug: Cytarabine consolidation
- type
- EXPERIMENTAL
- label
- Leukemia Stem Cells - Transplant
- description
- LSC present, randomized to allogeneic transplant
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age greater than or equal to 18 years 2. Able to give informed consent 3. New diagnosis of AML, other than APL or poor-risk AML, as defined in section 3.2 Exclusion criteria: 1. Has already had a bone marrow biopsy and aspirate to assess remission status after induction therapy 2. Any debilitating medical or psychiatric illness that would preclude ability to give informed consent or receive optimal treatment and follow-up 3. Pregnancy: Women of childbearing potential who are β- HCG+
References
Publications (0)
Data not yet available
No reference posted for this study.