Clinical trial · Interventional
Panobinostat Maintenance After HSCT fo High-risk AML and MDS
A Randomized, Multicenter Phase III Study to Assess the Efficacy of Panobinostat Maintenance Therapy vs. Standard of Care Following Allogeneic Stem Cell Transplantation in Patients With High-risk AML or MDS (ETAL-4 / HOVON-145)
NCT04326764CI-TRIAL-00063995terminatedPhase 3ClinicalTrials.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): Change of marketing authorisation holder
Summary
Brief summary (as posted)
Aim of this prospective randomized trial is to compare maintenance treatment with panobinostat interspersed with donor lymphocyte infusions (DLI) versus the standard approach of pre-emptive DLI alone in patients with poor-risk AML/MDS having favorably received an allogeneic HSCT followed by engraftment, donor chimerism and hematopoietic reconstitution.
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 Leukaemia (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes (MDS) | Myelodysplastic Syndrome | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Panobinostat | Drug | Panobinostat | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Panobinostat
- description
- Panobinostat 20 mg oral three times weekly every second week
- interventionNames
- Drug: Panobinostat
- type
- NO_INTERVENTION
- label
- Standard of Care
- description
- Treatment according to local standards
Primary outcomes (1)
- measure
- Overall survival (OS)
- timeFrame
- 5 years
- description
- OS is measured from date of randomization to the date of death or date of last follow up. Observations of patients alive at last follow up will be censored at date of last follow up.
Secondary outcomes (10)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients (18-70 years of age) * AML (except acute promyelocytic leukemia with PML-RARA and AML with BCR-ABL1) according to WHO 2016 classification 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 14-21 of the first induction cycle * adverse risk according to ELN 2017 risk stratification by genetics (Appendix 2) regardless of stage * secondary to MDS or radio-/chemotherapy * MRD positive before HSCT based on flow cytometry or PCR or * MDS with excess blasts (MDS-EB) according to the WHO 2016 classification, or high-risk or very high-risk according to IPSS-R and First allogeneic HSCT scheduled within the next 4-6 weeks using one of the following donors, conditioning regimens and strategies for GvHD prophylaxis: 1. Matched sibling or matched unrelated donor (i.e. 10/10 or 9/10 HLA-matched) or haploidentical family donor 2. Conditioning regimens: 1. Reduced-intensity conditioning: a. Fludarabine/Melphalan b. Fludarabine/Busulfan2 (FB2) (2) Myeloablative conditioning: 1. Fludarabine/Busulfan4 (FB4) 2. Busulfan/Cyclophosphamide (BU/CY) 3. Fludarabine/TBI 8 Gy 4. Cyclophosphamide/TBI 12 Gy (3) Fludarabine/Cyclophosphamide/TBI 2 Gy in combination with post-Tx cyclophosphamide (TP-CY) only (4) Thiotepa/Busulfan/Fludarabine (TBF) in the context of an haploidentical HSCT only (5) In case of active disease at HSCT, salvage chemotherapy prior to conditioning is permitted c. Strategies for GvHD prophylaxis: 1. HLA-matched donors: a. CSA + MMF +/- ATG b. CSA + MTX +/- ATG c. PT-CY + CSA 2. Haploidentical donors: d. PT-CY + CSA + MMF \- No history of significant cardiac disease and absence of active symptoms, otherwise documented left ventricular EF ≥ 40% \- Written informed consent for registration Exclusion Criteria: \- Prior treatment with a DAC inhibitor \- Hypersensitivity to the active substance or to any of the excipients of panobinostat * HIV or HCV antibody positive * Psychiatric disorder that interferes with ability to understand the study and give informed consent, and/or impacts study participation or follow-up. * Female patients who are pregnant or breast feeding * History of another primary malignancy that is currently clinically significant or currently requires active intervention
References
Publications (0)
Data not yet available
No reference posted for this study.