Prospective Evaluation of Ivosidenib Maintenance Following Allogeneic Stem Cell Transplantation in Patients With Acute Myeloid Leukemia or High-risk Myelodysplastic Neoplasia With IDH1 (Isocitrate Dehydrogenase 1) Mutation (PIVOT)
August 25, 2026 updated by: Technische Universität Dresden
A Prospective, Single-arm, Open-label, Multicenter Phase II Trial Evaluating the Efficacy and Safety of Ivosidenib Maintenance Therapy After Allogeneic Stem Cell Transplantation (alloSCT) in Patients With Acute Myeloid Leukemia (AML) and Myelodysplastic Neoplasia (MD) Carrying an IDH1 Mutation
maintenance of AML or MDS patients with known IDH1 mutation after allogeneic stem cell transplantation within past 100 days
Study Overview
Detailed Description
Determination of the efficacy of Ivosidenib to improve event-free survival when given as maintenance therapy following alloSCT.
Study Type
Interventional
Enrollment (Estimated)
76
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jan Moritz Middeke, Dr. med.
- Phone Number: +493514583192
- Email: pivot@ukdd.de
Study Contact Backup
- Name: Friedrich Stölzel, Prof. Dr. med.
- Phone Number: +493514583192
- Email: pivot@ukdd.de
Study Locations
-
-
-
Aachen, Germany
- Recruiting
- Universitätsklinikum Aachen
-
Contact:
- Edgar Jost
- Phone Number: +49241800
- Email: info@ukaachen.de
-
Chemnitz, Germany
- Recruiting
- Klinikum Chemnitz gGmbH
-
Contact:
- Mathias Hänel, Prof. Dr. med.
-
Dresden, Germany
- Recruiting
- Technische Universitaet Dresden, Medizinische Klinik und Poliklinik I
-
Contact:
- Jan Moritz Middeke, Dr. med.
- Phone Number: +493514583192
- Email: pivot@ukdd.de
-
Erlangen, Germany
- Not yet recruiting
- Universitaetsklinikum Erlangen AöR
-
Contact:
- Lena Stabel, Dr. med.
-
Essen, Germany
- Recruiting
- Universitätsklinikum Essen
-
Contact:
- Thomas Schroeder, Prof. Dr. med.
- Phone Number: +492017231861
- Email: studienzentrum-haemaSZT@uk-essen.de
-
Frankfurt am Main, Germany
- Recruiting
- Goethe Universität Frankfurt / Universitätsklinikum Frankfurt
-
Contact:
- Gesine Bug, PD Dr. med.
-
Greifswald, Germany
- Recruiting
- Universitätsmedizin Greifswald KöR
-
Contact:
- Adrian Schwarzer, Prof. Dr. med.
-
Halle, Germany
- Recruiting
- Martin-Luther-Universitaet Halle-Wittenberg
-
Contact:
- Lutz Peter Müller, Prof.
- Phone Number: +493455572924
- Email: innere4@uk-halle.de
-
Hamburg, Germany
- Recruiting
- University Medical Center Hamburg-Eppendorf
-
Contact:
- Evgeny Klyuchnikov, Dr. med.
- Phone Number: +494074100
- Email: info@uke.de
-
Jena, Germany
- Recruiting
- Universitätsklinikum Jena
-
Contact:
- Inken Hilgendorf, Apl. Prof. Dr. med.
- Phone Number: +4936419324201
- Email: onkologie@med.uni-jena.de
-
Kiel, Germany
- Recruiting
- Universitätsklinikum Schleswig-Holstein
-
Contact:
- Anca-Maria Albici, Dr. med.
- Phone Number: +4943150022501
- Email: Anca-Maria.Albici@uksh.de
-
Leipzig, Germany
- Recruiting
- Universität Leipzig
-
Contact:
- Barbara Jentzsch, PD Dr. med.
- Phone Number: +4934197109
- Email: Haematologie.Studieneinheit@medizin.uni-leipzig.de
-
Mainz, Germany
- Not yet recruiting
- Universitätsmedizin der Johannes Gutenberg-Universität Mainz
-
Contact:
- Eva Maria Drouet, Dr. med.
-
München, Germany
- Recruiting
- Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
-
Contact:
- Krischan Braitsch, Dr. med.
- Phone Number: +49 8941405736
- Email: Sandra.Eckert@mri.tum.de
-
Münster, Germany
- Recruiting
- Universität Münster
-
Contact:
- Matthias Stelljes, Prof. Dr. med.
- Phone Number: +492518352801
- Email: kmt@ukmuenster.de
-
Rostock, Germany
- Recruiting
- Rostock University Medical Center
-
Contact:
- Johannes Lakner
- Phone Number: +493814947459
- Email: onkologie@med.uni-rostock.de
-
Ulm, Germany
- Not yet recruiting
- Universitaetsklinikum Ulm
-
Contact:
- Elisa Sala, Dr. med.
- Phone Number: +4973150045501
- Email: Elisa.Sala@uniklinik-ulm.de
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion criterion:
- AML or MDS with IDH1 mutation
Exclusion criteria:
- active GvHD (graft vs host disease) grade III-IV according to Harris criteria requiring steroids >1mg/ kg prednisolone equivalent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Ivosidenib
|
oral
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
event-free survival
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 17, 2025
Primary Completion (Estimated)
October 1, 2029
Study Completion (Estimated)
February 1, 2030
Study Registration Dates
First Submitted
November 27, 2024
First Submitted That Met QC Criteria
December 4, 2024
First Posted (Actual)
December 5, 2024
Study Record Updates
Last Update Posted (Actual)
August 26, 2026
Last Update Submitted That Met QC Criteria
August 25, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TUD-PIVOT1-085
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.