Status:
TERMINATED
Panobinostat Maintenance After HSCT fo High-risk AML and MDS
Lead Sponsor:
Goethe University
Collaborating Sponsors:
Stichting Hemato-Oncologie voor Volwassenen Nederland
Polish Adult Leukemia Group
Conditions:
Acute Myeloid Leukaemia (AML)
Myelodysplastic Syndromes (MDS)
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
Allogeneic hematopoietic stem cell transplantation (HSCT) has been shown to improve the outcome of poor-risk AML and MDS in both younger and older patients. Reduced-intensity conditioning (RIC) regime...
Eligibility Criteria
Inclusion
- 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:
- Matched sibling or matched unrelated donor (i.e. 10/10 or 9/10 HLA-matched) or haploidentical family donor
- Conditioning regimens:
- Reduced-intensity conditioning:
- a. Fludarabine/Melphalan b. Fludarabine/Busulfan2 (FB2) (2) Myeloablative conditioning:
- Fludarabine/Busulfan4 (FB4)
- Busulfan/Cyclophosphamide (BU/CY)
- Fludarabine/TBI 8 Gy
- 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:
- HLA-matched donors:
- a. CSA + MMF +/- ATG b. CSA + MTX +/- ATG c. PT-CY + CSA
- 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
- \- 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
Key Trial Info
Start Date :
July 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2023
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04326764
Start Date
July 24 2018
End Date
February 13 2023
Last Update
February 16 2023
Active Locations (19)
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1
Robert Bosch Krankenhaus
Stuttgart, Baden-Wurttemberg, Germany, 70376
2
University Hospital Jena
Jena, Thuringia, Germany, 07747
3
Universitätsklinikum Leipzig
Leipzig, Thuringia, Germany, 04103
4
Klinikum Augsburg
Augsburg, Germany