NCT06717958 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
| NCT ID | NCT06717958 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Technische Universität Dresden |
| Condition | AML |
| Study Type | INTERVENTIONAL |
| Enrollment | 76 participants |
| Start Date | 2025-06-17 |
| Primary Completion | 2029-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 76 participants in total. It began in 2025-06-17 with a primary completion date of 2029-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
maintenance of AML or MDS patients with known IDH1 mutation after allogeneic stem cell transplantation within past 100 days
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06717958 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying AML. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06717958 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06717958 currently recruiting?
Yes, NCT06717958 is actively recruiting participants. Contact the research team at pivot@ukdd.de for enrollment information.
Where is the NCT06717958 trial being conducted?
This trial is being conducted at Aachen, Germany, Dresden, Germany, Essen, Germany, Halle, Germany and 8 additional locations.
Who is sponsoring the NCT06717958 clinical trial?
NCT06717958 is sponsored by Technische Universität Dresden. The trial plans to enroll 76 participants.