AMLPhase 2PIVOTNCT06717958
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
A Phase 2 study testing Ivosidenib 250 MG (milligram) in people with AML and MDS, run by Technische Universität Dresden at 17 sites in Germany.
Trial summary
maintenance of AML or MDS patients with known IDH1 mutation after allogeneic stem cell transplantation within past 100 days Read more about this study
- Who is it for?
- Ages 18 to 75 years
- What is being tested?
- Ivosidenib 250 MG (milligram)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 17 sitesGermany
- Study dates
- 17 Jun 2025to 1 Feb 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AML or MDS with IDH1 mutation
Who cannot join
- active GvHD (graft vs host disease) grade III-IV according to Harris criteria requiring steroids >1mg/ kg prednisolone equivalent
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
Germany17 sites, 17 recruiting
- Recruiting
Universitätsklinikum Aachen
Aachen
Edgar Jost, +49241800, info@ukaachen.de
- Recruiting
Klinikum Chemnitz gGmbH
Chemnitz
Mathias Hänel, Prof. Dr. med.
- Recruiting
Technische Universitaet Dresden, Medizinische Klinik und Poliklinik I
Dresden
Jan Moritz Middeke, Dr. med., +493514583192, pivot@ukdd.de
- Not yet recruiting
Universitaetsklinikum Erlangen AöR
Erlangen
Lena Stabel, Dr. med.
- Recruiting
Universitätsklinikum Essen
Essen
Thomas Schroeder, Prof. Dr. med., +492017231861, studienzentrum-haemaSZT@uk-essen.de
- Recruiting
Goethe Universität Frankfurt / Universitätsklinikum Frankfurt
Frankfurt am Main
Gesine Bug, PD Dr. med.
- Recruiting
Universitätsmedizin Greifswald KöR
Greifswald
Adrian Schwarzer, Prof. Dr. med.
- Recruiting
Martin-Luther-Universitaet Halle-Wittenberg
Halle
Lutz Peter Müller, Prof., +493455572924, innere4@uk-halle.de
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg
Evgeny Klyuchnikov, Dr. med., +494074100, info@uke.de
- Recruiting
Universitätsklinikum Jena
Jena
Inken Hilgendorf, Apl. Prof. Dr. med., +4936419324201, onkologie@med.uni-jena.de
- Recruiting
Universitätsklinikum Schleswig-Holstein
Kiel
Anca-Maria Albici, Dr. med., +4943150022501, Anca-Maria.Albici@uksh.de
- Recruiting
Universität Leipzig
Leipzig
Barbara Jentzsch, PD Dr. med., +4934197109, Haematologie.Studieneinheit@medizin.uni-leipzig.de
- Not yet recruiting
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz
Eva Maria Drouet, Dr. med.
- Recruiting
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
München
Krischan Braitsch, Dr. med., +49 8941405736, Sandra.Eckert@mri.tum.de
- Recruiting
Universität Münster
Münster
Matthias Stelljes, Prof. Dr. med., +492518352801, kmt@ukmuenster.de
- Recruiting
Rostock University Medical Center
Rostock
Johannes Lakner, +493814947459, onkologie@med.uni-rostock.de
- Not yet recruiting
Universitaetsklinikum Ulm
Ulm
Elisa Sala, Dr. med., +4973150045501, Elisa.Sala@uniklinik-ulm.de
About this study
Official title: 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
Read the detailed description
Determination of the efficacy of Ivosidenib to improve event-free survival when given as maintenance therapy following alloSCT.
- Being tested
- Ivosidenib 250 MG (milligram)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivosidenib 250 MG (milligram)Drug
oral
| Study group | Role | What they receive |
|---|---|---|
| Ivosidenib | Experimental | Not described Receives: Drug: Ivosidenib 250 MG (milligram) |
What is being measured
The primary outcome is the main question the study is designed to answer.
event-free survival
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start17 Jun 2025
- Primary completion1 Oct 2029 (estimated)
- Study completion1 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMLStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717958
- Sponsor's protocol ID
- TUD-PIVOT1-085
- Acronym
- PIVOT
- Status last verified
- Aug 2026
- First submitted
- 27 Nov 2024
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06717958
- Acronym / sponsor ID
- PIVOT / TUD-PIVOT1-085
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 1 Feb 2030 (estimated)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
maintenance of AML or MDS patients with known IDH1 mutation after allogeneic stem cell transplantation within past 100 days
Detailed description
Determination of the efficacy of Ivosidenib to improve event-free survival when given as maintenance therapy following alloSCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ivosidenib | Experimental | Drug: Ivosidenib 250 MG (milligram) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- AML or MDS with IDH1 mutation
Key exclusion criteria (1 listed)
- active GvHD (graft vs host disease) grade III-IV according to Harris criteria requiring steroids >1mg/ kg prednisolone equivalent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ivosidenib 250 MG (milligram)oral | Drug | Ivosidenib |
Primary outcome
event-free survival
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
Related trials for AML
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ivosidenib 250 MG (milligram) in people with AML and MDS, run by Technische Universität Dresden at 17 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Moritz Middeke, Dr. med. (+493514583192, pivot@ukdd.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
event-free survival (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.