Blood cancer combo trial pulled before it even started
NCT ID NCT06597734
First seen Jun 24, 2026 · Last updated Sep 11, 2026 · Updated 4 times
Summary
This study was designed to test whether adding olutasidenib to standard chemotherapy drugs could help control certain blood cancers in people with an IDH1 gene mutation. The trial was withdrawn before enrolling any participants, so no results are available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Olutasidenib
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Started
-
Jan 2025
- Finished
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Jun 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Pathologically proven higher-risk MDS/CMML or advanced MPN 1. MDS participants must have International Prognostic Scoring System (IPSS) intermediate-2- or high-risk disease or Revised IPSS (IPSS-R) score \>= 3.5 or Molecular IPSS (IPSS-M) moderate high-, high-, or very high-risk disease or bone marrow blast percentage. 2. CMML patients must have CPSS-Mol int-1, int-2, or high-ris disease (Elena C et al, Blood 2016) 3. Advanced MPN is defined as bone marrow blast percentage \>=/=10%. 4. Participants on the treatment-naive arm must not have received a prior HMA. Agents such as growth factors (e.g. erythropoietin stimulating agents, luspatercept, eltrombopag, granulocyte colony stimulating factors), cyclosporine, and/or hydroxyurea are allowed. 5. Patients on the previously-treated arm must have received a prior HMA and/or ivosidenib. Prior stem cell transplantation in allowed\> 2. Participants must have a documented IDH1 mutation 3. Patients with previously-treated MDS must be ineligible to receive treatment with ivosidenib or have progressed on treatment with ivosidenib. 4. Participants \>=/= 18 years old 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Appendix A) 6. Acceptable liver function 1. Bilirubin \</= 2 times upper limit of normal (ULN) or \<;/= 3 times ULN in participants with Gilbert Syndrome 2. Aspartate transaminase (AST), alanine transaminase (ALT), and alkaline phosphatase \</= 3 times ULN 7. Acceptable renal function calculated creatinine clearance \>/= 50 mL/min (as assessed by Cockcroft-Gault, MDRD, or CKD-Epi validated measures) 8. Negative serum or urine pregnancy test if female of childbearing potential c. For fertile men and women, agreement to use highly effective contraceptive methods for the duration of study participation and 90 days after the last dose of study medication d. Agreement for male participants not to donate sperm and for female participants of childbearing potential not to donate ova during the study and for 90 days after the final dose of study drug 9. Ability and willingness to sign informed consent prior to beginning study and undergoing procedures Exclusion Criteria: 1. Participants unable to swallow oral medications, or participants with gastrointestinal conditions (e.g., malabsorption, resection, etc.) deemed by the Investigator to jeopardize intestinal absorption 2. Participants with any concurrent uncontrolled clinically significant medical condition, including life-threatening severe infection or psychiatric illness, which could place the participant at unacceptable risk of study treatment 3. Patients must have discontinued prior chemotherapy at least 1 week prior to the start of study treatment. Patients with MPN must be off JAK inhibitors at the start of study treatment 4. Patients with active graft-versus-host-disease (GVHD) status post stem cell transplantation, including active chronic GVHD requiring topical therapy. Patients must have discontinued calcineurin inhibitors at least 4 weeks prior to the start of study treatment 5. Known active hepatitis B (HBV) or hepatitis C (HCV) or HIV infection 6. Pregnant or nursing women or women of childbearing potential not using highly effective contraception; male participants not using highly effective contraception 7. Participants with white blood cell count \> 25 x109/L Note: hydroxyurea use is permitted to meet this criterion 8. Unwillingness or inability to comply with procedures either required in this protocol or considered standard of care
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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