NCT04326764

Panobinostat Maintenance After HSCT fo High-risk AML and MDS

Terminated Phase 3 Last updated 16 February 2023

What this trial tests

Phase 3 trial testing Panobinostat in Acute Myeloid Leukaemia (AML) in 52 participants. Terminated before completion.

Timeline

24 July 2018

Primary endpoint
13 February 2023

13 February 2023

Quick facts

Lead sponsor	Goethe University
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	52
Start date	24 July 2018
Primary completion	13 February 2023
Estimated completion	13 February 2023
Sites	19 locations across Netherlands, Germany

Drugs / interventions tested

• Panobinostat (PANOBINOSTAT) — full drug profile →

Conditions studied

• Acute Myeloid Leukaemia (AML) — all drugs for Acute Myeloid Leukaemia (AML) →
• Myelodysplastic Syndromes (MDS) — all drugs for Myelodysplastic Syndromes (MDS) →

Sponsor

Goethe University

Who can join

Adults 18 to 70, any sex, with Acute Myeloid Leukaemia (AML) or Myelodysplastic Syndromes (MDS). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Recent developments in epigenetic cancer therapeutics: clinical advancement and emerging trends.
   Nepali K, Liou JP. · · 2021 · cited 122× · PMID 33840388 · DOI 10.1186/s12929-021-00721-x
2. Epigenetic regulation in hematopoiesis and its implications in the targeted therapy of hematologic malignancies.
   Zhao A, Zhou H, Yang J, Li M, et al · · 2023 · cited 81× · PMID 36797244 · DOI 10.1038/s41392-023-01342-6
3. Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia: Who, When, and How?
   Loke J, Buka R, Craddock C. · · 2021 · cited 72× · PMID 34012445 · DOI 10.3389/fimmu.2021.659595
4. HDAC Inhibitors: Dissecting Mechanisms of Action to Counter Tumor Heterogeneity.
   Karagiannis D, Rampias T. · · 2021 · cited 58× · PMID 34298787 · DOI 10.3390/cancers13143575
5. Clinical epigenetics settings for cancer and cardiovascular diseases: real-life applications of network medicine at the bedside.
   Sarno F, Benincasa G, List M, Barabasi AL, et al · · 2021 · cited 49× · PMID 33785068 · DOI 10.1186/s13148-021-01047-z
6. Prognostic and therapeutic implications of measurable residual disease in acute myeloid leukemia.
   Aitken MJL, Ravandi F, Patel KP, Short NJ. · · 2021 · cited 40× · PMID 34479626 · DOI 10.1186/s13045-021-01148-5
7. New drugs before, during, and after hematopoietic stem cell transplantation for patients with acute myeloid leukemia.
   Mohty R, El Hamed R, Brissot E, Bazarbachi A, et al · · 2023 · cited 28× · PMID 36722403 · DOI 10.3324/haematol.2022.280798
8. How metabolism bridles cytotoxic CD8⁺ T cells through epigenetic modifications.
   Van Acker HH, Ma S, Scolaro T, Kaech SM, et al · · 2021 · cited 24× · PMID 33867272 · DOI 10.1016/j.it.2021.03.006