Clinical trial · Interventional
Phase I/II Study With Oral Panobinostat Maintenance Therapy Following Allogeneic Stem Cell Transplantation in Patients With High Risk Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML)
Phase I/II Study With Oral Panobinostat Maintenance Therapy Following Allogeneic Stem Cell Transplantation in Patients With High Risk MDS or AML (PANOBEST)
- 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)
The study's primary objective is to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of Panobinostat when administered within 150 days after hematopoietic stem cell transplantation (HSCT) and given in conjunction with standard immunosuppressive therapy after HSCT for patients with high-risk Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML). Secondary objectives are * To determine safety and tolerability of panobinostat * To determine overall and disease-free survival at 12 months after HSCT * To evaluate immunoregulatory properties of panobinostat * To evaluate patient-reported health-related quality of life (HRQL) The hypothesis of this study is that panobinostat can be an effective drug in preventing relapse of MDS and AML patients with high-risk features after hematopoietic stem cell transplantation with reduced-intensity conditioning (RIC-HSCT) while at the same time reducing graft-versus-host disease (GvHD) with preservation of graft-versus-leukemia (GvL) effect.
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 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Panobinostat | Drug | Panobinostat | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Panobinostat Arm A
- interventionNames
- Drug: Panobinostat
- type
- EXPERIMENTAL
- label
- Panobinostat Arm B
- interventionNames
- Drug: Panobinostat
Primary outcomes (2)
- measure
- Maximum tolerated dose (MTD) of panobinostat
- timeFrame
- after 28 days of administration
- measure
- Dose-limiting toxicity (MTD) of Panobinostat
- timeFrame
- after 28 days of administration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * AML (except acute promyelocytic leukemia, AML M3) with high-risk features defined as one or more of the following criteria: * refractory to or relapsed after at least one cycle of standard chemotherapy * \> 10% bone marrow blasts at day 15 of the first induction cycle * adverse risk cytogenetics including complex karyotype (≥ 3 abnormalities or abnormalities of chromosomes 3, 5 or 7) regardless of stage * secondary to MDS or radio-/chemotherapy or * MDS RAEB according to the WHO classification or intermediate-2 or high-risk according to IPSS or * Chronic myelomonocytic leukemia (CMML) with ≥ 5% bone marrow blasts and * Allogeneic HSCT with reduced intensity conditioning (see Section 15.1 for definition) performed within 60 - 150 days prior to study entry * Complete hematologic remission documented by bone marrow aspiration within 28 days prior to study entry Exclusion Criteria: * Active acute GvHD overall grade 2 - 4 * Prior treatment with a deacetylase (DAC) inhibitor * Patients with impaired cardiac function or other concurrent severe and/or uncontrolled medical conditions * Clinical symptoms suggesting central nervous system (CNS) leukemia * Patient has an impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral panobinostat
References
Publications (0)
Data not yet available