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Panobinostat Maintenance After HSCT fo High-risk AML and MDS

NCT04326764 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2023-02-16

No results posted yet for this study

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 in patients with poor-risk AML/MDS having favorably received an allogeneic HSCT followed by engraftment, donor chimerism and hematopoietic reconstitution.

Conditions

  • Acute Myeloid Leukaemia (AML)
  • Myelodysplastic Syndromes (MDS)

Interventions

DRUG

Panobinostat

Panobinostat should be taken orally once on each scheduled day at about the same time, either with or without food. Each dose of panobinostat should be taken with a cup of water. The capsules should be swallowed as whole. If vomiting occurs during the course of treatment, no re-dosing is allowed before the next scheduled dose. If one dose is forgotten during the morning on a scheduled treatment day then the missed dose should be taken on that same day within 12 hours. After more than 12 hours, that day's dose should be withheld, and the patient should wait to take panobinostat until the next schedule treatment day. The patient should then continue treatment with the original dosing schedule. Panobinostat will be administered at a dose of 20 mg three times weekly (TIW) every second week and will be dosed on a flat scale of mg/day and not by weight or body surface area. Panobinostat will be dispensed as a 20 mg capsule or as two 10 mg capsules.

Sponsors & Collaborators

  • Stichting Hemato-Oncologie voor Volwassenen Nederland

    collaborator OTHER

  • Polish Adult Leukemia Group

    collaborator OTHER

  • Schweizerische Arbeitsgemeinschaft für klinische Krebsforschung

    collaborator UNKNOWN

  • Goethe University

    lead OTHER

Principal Investigators

  • Gesine Bug, PD Dr. · Goethe University Frankfurt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-24
Primary Completion
2023-02-13
Completion
2023-02-13

Countries

  • Germany
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04326764 on ClinicalTrials.gov