Clinical trial · Interventional
Fludarabine Phosphate, Clofarabine, and Busulfan With Vorinostat in Treating Patients With Acute Leukemia in Remission or Relapse Undergoing Donor Stem Cell Transplant
Fludarabine/Clofarabine/Busulfan Combined With SAHA in Patients Receiving Allogeneic Hematopoietic Stem Cell Transplantation for Acute Leukemia
- 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)
This phase I trial studies the side effects and best dose of vorinostat when given together with fludarabine phosphate, clofarabine, and busulfan in treating patients with acute leukemia that is under control (remission) or has returned (relapse) undergoing donor stem cell transplant. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fludarabine phosphate, clofarabine, and busulfan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving vorinostat together with fludarabine phosphate, clofarabine, and busulfan before a donor stem cell transplant may be a better treatment for patients with acute leukemia.
Conditions
Conditions (7)
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 Lymphoblastic Leukemia in Remission | Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Acute Myeloid Leukemia in Remission | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Allogeneic Hematopoietic Stem Cell Transplantation Recipient | — | UNRESOLVED | — |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
| Previously Treated Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
| Recurrent Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Recurrent Acute Myeloid Leukemia | Acute Myeloid Leukemia |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogeneic Bone Marrow Transplantation | Procedure | — | UNRESOLVED |
| Allogeneic Hematopoietic Stem Cell Transplantation | Procedure | — | UNRESOLVED |
| Anti-Thymocyte Globulin | Biological | — | UNRESOLVED |
| Busulfan | Drug | Busulfan | ALIAS |
| Clofarabine | Drug | Clofarabine | ALIAS |
| Fludarabine Phosphate | Drug | Fludarabine | ALIAS |
| Peripheral Blood Stem Cell Transplantation | Procedure | — | UNRESOLVED |
| Pharmacological Study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (vorinostat, chemotherapy, SCT)
- description
- CONDITIONING REGIMEN: Patients receive vorinostat PO QD, fludarabine phosphate IV over 1 hour, clofarabine IV over 1 hour, and busulfan IV over 3 hours on days -6 to -3. Patients receiving a transplant from a HLA-matched unrelated donor, receive anti-thymocyte globulin IV over 4 hours on days -3 to -1. TRANSPLANT: Patients undergo allogeneic peripheral blood stem cell or bone marrow transplant on day 0.
- interventionNames
- Procedure: Allogeneic Bone Marrow Transplantation
- Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
- Biological: Anti-Thymocyte Globulin
- Drug: Busulfan
- Drug: Clofarabine
- Drug: Fludarabine Phosphate
- Procedure: Peripheral Blood Stem Cell Transplantation
- Other: Pharmacological Study
- Drug: Vorinostat
Primary outcomes (1)
- measure
- Maximum tolerated dose of vorinostat when given in combination with fludarabine phosphate, clofarabine, and busulfan before stem cell transplant assessed using Common Terminology Criteria for Adverse Events version 4
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with biopsy-proven acute lymphoblastic leukemia, acute myeloid leukemia, or myelodysplastic syndrome in remission or relapse * Estimated creatinine clearance at least 50 ml/min * Bilirubin equal or less than 1.5 (unless Gilbert's syndrome) * Serum glutamate pyruvate transaminase (SGPT) \< 3 x upper limit of normal * Alkaline phosphatase \< 2 x upper limit of normal * Pulmonary function with forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and diffusing capacity of the lungs for carbon monoxide (DLCO) at least 45% of expected corrected for hemoglobin; children unable to perform pulmonary functions must have an oxygen saturation greater than 92% at room air * Left ventricular ejection fraction at least 45% on appropriate medical therapy; no uncontrolled arrhythmias or symptomatic cardiac disease * Zubrod performance status 0-1 or Lansky/Karnofsky performance status (PS) equal or greater to 80% * Patients must have a related, genotypically HLA identical donor, or they must have an unrelated donor who is 8/8 HLA match by high resolution typing * Patient or patient's legal representative, parent(s) or guardian should provide written informed consent; assent of a minor if participant's age is at least seven and less than eighteen years * Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months and no previous surgical sterilization Exclusion Criteria: * Patients with active central nervous system (CNS) disease * Evidence of acute or chronic active hepatitis or cirrhosis * Uncontrolled infection, including human immunodeficiency virus (HIV), human T-lymphotropic virus (HTLV)-1, hepatitis B or hepatitis C viremia * Prior allogeneic SCT * Prior autologous SCT in last 12 months * Patients with acute myeloid leukemia (AML) in first remission after one course of induction and with favorable cytogenetics (t\[8;21\], inv 16, or t\[15;17\]) and/or molecular profile (nucleophosmin \[NPM\]1) * Prior radiation to liver in form of total body or involved field
References
Publications (0)
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