Clinical trial · Interventional
Donor Stem Cell Transplant or Bone Marrow Transplant in Treating Patients With Acute Myeloid Leukemia in Remission
Allogeneic Hematopoietic Cell Transplantation for Patients With Acute Myelogenous Leukemia in Remission Using HLA-Matched Sibling Donors, HLA-Matched Unrelated Donors, or HLA-Mismatched Familial Donors - A Phase 2 Study
- 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 a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also 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 cyclosporine and methotrexate before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well donor stem cell transplant or bone marrow transplant works in treating patients with acute myeloid leukemia in 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 (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| anti-thymocyte globulin | Biological | — | UNRESOLVED |
| busulfan | Drug | Busulfan | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cyclosporine | Drug | — | UNRESOLVED |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- transplantation
- description
- perform allogeneic HCT for patients with AML in CR1; then analyze various pre-transplantation variable, including donor type, for correlation to outcomes
- interventionNames
- Biological: anti-thymocyte globulin
- Drug: busulfan
- Drug: cyclophosphamide
- Drug: cyclosporine
- Drug: fludarabine phosphate
- Drug: methotrexate
- Procedure: allogeneic hematopoietic stem cell transplantation
Primary outcomes (1)
- measure
- Efficacy of the treatment measured in terms of frequency of relapse and duration of remission
- timeFrame
- up to 2 years after transplantation
- description
- duration of CR, leukemia recurrence
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of acute myeloid leukemia (AML) meeting 1 of the following criteria: * Achieved complete response (CR1) after induction chemotherapy * Recurrent AML that went into second CR (CR2) after salvage chemotherapy, except those who have undergone prior allogeneic HSCT * No acute promyelocytic leukemia or acute myeloid leukemia with chromosomal changes t(8;21), inv 16, or t(15;17) * Must have a donor available meeting one of the following criteria: * HLA-matched sibling of 65 years or younger * 6/6 HLA-matched unrelated donor (younger than 55 years) for antigen A, B, and DR * HLA-mismatched family member (offspring, parents, haploidentical sibling) PATIENT CHARACTERISTICS: * Karnofsky performance status 70-100% * Bilirubin \< 2.0 mg/dL * AST \< 3 times the upper limit of normal * Creatinine \< 2.0 mg/dL * Ejection fraction \> 40% on MUGA scan * Negative pregnancy test PRIOR CONCURRENT THERAPY: * See Disease Characteristics
References
Publications (0)
Data not yet available