Clinical trial · Interventional
Clofarabine and High-Dose Melphalan Followed by Donor Stem Cell Transplant in Patients With Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, or Myelodysplastic Syndromes
A Phase I Study of Clofarabine Plus High Dose Melphalan as a Conditioning Regimen for Allogeneic Transplantation
- 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, such as clofarabine and melphalan, before a donor stem cell transplant helps stop the growth of cancer or abnormal 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 mycophenolate mofetil after the transplant may stop this from happening. PURPOSE: This phase I trial is studying the side effects and best dose of clofarabine when given together with high-dose melphalan followed by a donor stem cell transplant in treating patients with acute myeloid leukemia, acute lymphocytic leukemia, or myelodysplastic syndromes.
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 (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| clofarabine | Drug | Clofarabine | ALIAS |
| flow cytometry | Other | — | UNRESOLVED |
| gene expression analysis | Genetic | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| melphalan | Drug | Melphalan | ALIAS |
| reverse transcriptase-polymerase chain reaction | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Maximum tolerated dose
- timeFrame
- 4 weeks from the start of treatment
- measure
- Dose-limiting toxicity as assessed by NCI CTCAE v3.0 and the Modified Bearman scale
- timeFrame
- 4 weeks from the start of treatment
- measure
- Graft failure or rejection
- timeFrame
- 35 days post-transplant
Secondary outcomes (2)
- measure
- Efficacy
- timeFrame
- One year post-transplant
- measure
- Correlative laboratory studies of engraftment, immune reconstitution, and therapeutic outcomes
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of one of the following: * Acute myeloid leukemia * Acute lymphocytic leukemia * Myelodysplastic syndromes * Disease meets 1 of the following criteria: * In first complete remission (CR) * In second CR * In relapse * No more than 50% blasts in bone marrow * Not deemed eligible for standard transplantation regimens by the attending physician, or at high risk for relapse * No suspected or proven CNS leukemia * HLA-matched (6/6) sibling donor available PATIENT CHARACTERISTICS: * Karnofsky performance status 50-100% * Glomerular filtration rate (pediatric patients) or creatinine clearance ≥ 60 mL/min OR serum creatinine \< 1.5 times upper limit of normal (ULN) * Serum bilirubin ≤ 2.0 mg/dL * AST and ALT ≤ 2.5 times ULN * LVEF ≥ 50% by ECHO or MUGA scan * DLCO or FEV\_1 ≥ 40% predicted * Not pregnant * Negative pregnancy test * No concurrent uncontrolled illness including, but not limited to, any of the following: * Ongoing, active, or poorly controlled infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Poorly controlled pulmonary disease * Psychiatric illness/social situation that would limit compliance with study requirement * No active cytomegalovirus (CMV) or fungal disease * HIV negative PRIOR CONCURRENT THERAPY: * Recovered from prior intensive chemotherapy (pediatric patients) * At least 100 days since prior autologous stem cell transplantation * At least 100 days since prior radiotherapy administered as part of a transplantation conditioning regimen * At least 4 weeks since prior chemotherapy * At least 24 hours since prior hydroxyurea for blast count control
References
Publications (0)
Data not yet available