Olutasidenib in Relapsed IDH1 Mutated AML Patients Who Have Previously Received Venetoclax
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This is a prospective, single-arm phase 2 pilot study to assess the response rate of IDH1 mutated relapsed/refractory acute myeloid leukemia (AML) patients who receive olutasidenib after progressing on venetoclax based regimens. Each cycle will last for 28 days. Patients will receive olutasidenib 150 mg orally twice daily Day 1 through Day 28. After 3 cycles of olutasidenib, azacitidine 75 mg/m2 given on Day 1 through Day 7 may be added at the discretion of the treating investigator if the patient has not achieved a complete remission. Subjects with at least a PR after 6 cycles of treatment will continue treatment as previously described. Subjects without at least a partial response (PR) after 6 cycles of treatment will move to long term follow up.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Potwierdzona białaczka ostra, która nawróciła lub nie odpowiada na leczenie
- •Białaczka z mutacją genu IDH1
- •Poprzednie leczenie zawierało venetoclax
- •Maksymalnie 2 poprzednie rodzaje leczenia
- •Prawidłowa funkcja nerek (czyszczenie kreatyniny ≥30 mL/min)
- •Prawidłowa funkcja wątroby
- •Dla kobiet: ujemny test ciążowy przed rozpoczęciem leczenia
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- September 2, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, United States
Trial contact
Timothy Pardee
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/3/2026.
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