A Phase 2 Study Evaluating Olutasidenib in Patients With IDH1-mutated Clonal Cytopenia of Undetermined Significance and Lower-risk Myelodysplastic/Syndromes/Chronic Myelomonocytic Leukemia.
NCT06566742 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2026-03-04
Summary
To learn if olutasidenib can help to control CCUS, MDS, and/or CMML. The safety of the drug will also be studied.
Conditions
- Myelodysplastic Syndromes
- Chronic Myelomonocytic Leukemia
- Clonal Cytopenia of Undetermined Significance
Interventions
- DRUG
-
Olutasidenib
Given by PO
Sponsors & Collaborators
-
Rigel Pharmaceuticals
collaborator INDUSTRY -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Kelly Chien, MD · M.D. Anderson Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-12-10
- Primary Completion
- 2027-08-31
- Completion
- 2029-08-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Phase II Nilotinib With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML)
NCT00129740 ·Status: COMPLETED ·Phase: PHASE2
-
Differentiation Therapy With Decitabine in Treating Patients With Myelodysplastic Syndrome
NCT01165996 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study to Investigate Fadraciclib (CYC065), in Subjects With Leukemia or Myelodysplastic Syndrome (MDS)
NCT05168904 ·Status: SUSPENDED ·Phase: PHASE1/PHASE2
-
A Phase I Clinical Trial of OXi4503 for Relapsed and Refractory AML and MDS
NCT01085656 ·Status: TERMINATED ·Phase: PHASE1
-
A Study of HMPL-306 in Patients With IDH1 and/or IDH2 Mutation of Relapsed/Refractory Myeloid Leukemia/Neoplasms
NCT04272957 ·Status: UNKNOWN ·Phase: PHASE1
-
A Safety and Preliminary Efficacy Study of CC-99282 in Combination With Obinutuzumab in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
NCT04434196 ·Status: COMPLETED ·Phase: PHASE1
-
Onvansertib for the Treatment of Recurrent or Refractory Chronic Myelomonocytic Leukemia and Myelodysplastic Syndrome/MPN Overlap Neoplasms
NCT05549661 ·Status: RECRUITING ·Phase: PHASE1
-
Safety and Efficacy Study of CC-486 in Subjects With Myelodysplastic Syndromes
NCT02281084 ·Status: COMPLETED ·Phase: PHASE2
-
SJG-136 in Treating Patients With Relapsed or Refractory Acute Leukemia, Myelodysplastic Syndromes, Blastic Phase Chronic Myelogenous Leukemia, or Chronic Lymphocytic Leukemia
NCT00301769 ·Status: TERMINATED ·Phase: PHASE1
-
Long Term Efficacy and Safety of Zoledronic Acid Treatment in Patients With Bone Metastases
NCT00434447 ·Status: COMPLETED ·Phase: PHASE4
-
Clofarabine Bone Marrow Cytoreduction
NCT00724009 ·Status: COMPLETED ·Phase: PHASE2
-
A Study Evaluating the Efficacy of Obinutuzumab and Bendamustine Treatment in Participants With Refractory or Relapsed Chronic Lymphocytic Leukemia
NCT02071225 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase I, Open-Label, Dose-Escalation Study of CC-11006 In Subjects With Low- or Intermediate-1 Risk Myelodysplastic Syndromes
NCT00458159 ·Status: TERMINATED ·Phase: PHASE1
-
A Phase I/II Study of OPN-305 in Second-line Lower Risk Myelodysplastic Syndrome
NCT02363491 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Mitoxantrone, Etoposide, and Cytarabine (MEC) Plus Lenalidomide for Relapsed or Refractory Acute Myeloid Leukemia
NCT03118466 ·Status: COMPLETED ·Phase: PHASE2
-
Lenalidomide for Myelodysplastic Syndrome Refractory to Hypomethylating Agents
NCT01246076 ·Status: COMPLETED ·Phase: PHASE2
-
Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome
NCT00044382 ·Status: COMPLETED ·Phase: PHASE2
-
Alemtuzumab-Ofatumumab in Previously Untreated Symptomatic Chronic Lymphocytic Leukemia
NCT01361711 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia
NCT01564784 ·Status: COMPLETED ·Phase: PHASE3
-
Ofatumumab and High-dose Methylprednisolone in Patients With Chronic Lymphocytic Leukemia (CLL)
NCT01191190 ·Status: COMPLETED ·Phase: PHASE2
-
IGF-MTX Conjugate in the Treatment of Myelodysplastic Syndrome
NCT03175978 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Using the Anticancer Drug Olaparib to Treat Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome With an Isocitrate Dehydrogenase (IDH) Mutation
NCT03953898 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Study to Evaluate the Safety and Efficacy of the Combination of Tirabrutinib and Idelalisib With and Without Obinutuzumab in Adults With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
NCT02968563 ·Status: COMPLETED ·Phase: PHASE2
-
Phase II Study Assessing the Efficacy and Toxicity of Olverembatinib Monotherapy in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
NCT06817720 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of Obinutuzumab + Bendamustine (BG) in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL)
NCT02320487 ·Status: COMPLETED ·Phase: PHASE2