Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia
NCT06001788 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 171
Last updated 2026-04-14
Summary
The safety, tolerability, and antileukemic response of ziftomenib in combination with standard of care treatments for patients with relapsed/refractory acute myeloid leukemia will be examined with the following agents: FLAG-IDA, low-dose cytarabine, and gilteritinib.
Conditions
- AML
- AML With Mutated NPM1
- Hematologic Malignancy
- KMT2Ar
- NPM1 Mutation
- MLL Rearrangement
- Leukemia
- Acute Myeloid Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Acute Leukemia
- Neoplasms by Histologic Type
Interventions
- DRUG
-
Ziftomenib
Oral administration
- DRUG
-
Intravenous infusion
- DRUG
-
Idarubicin
Intravenous infusion
- DRUG
-
Intravenous Infusion
- DRUG
-
Gilteritinib
Oral administration
- BIOLOGICAL
-
Granulocyte colony-stimulating factor
Subcutaneous injection
Sponsors & Collaborators
-
Kura Oncology, Inc.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-02-22
- Primary Completion
- 2026-08-31
- Completion
- 2027-08-31
- FDA Drug
- Yes
Countries
- United States
- Italy
- Spain
Study Locations
More Related Trials
-
Open Label Study to Evaluate Safety and Efficacy of 2 Doses of Quizartinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia
NCT01565668 ·Status: COMPLETED ·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
-
Phase II Clofarabine and Cytarabine for Newly Diagnosed Acute Myeloid Leukemia
NCT01960387 ·Status: TERMINATED ·Phase: PHASE2
-
Pentostatin, Alemtuzumab, and Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
NCT00669318 ·Status: COMPLETED ·Phase: PHASE2
-
Eltrombopag Olamine in Treating Patients With Relapsed/Refractory Acute Myeloid Leukemia
NCT01550185 ·Status: TERMINATED ·Phase: PHASE1
-
A Study of SKLB1028 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia
NCT02859948 ·Status: UNKNOWN ·Phase: PHASE1
-
Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML
NCT07007312 ·Status: RECRUITING ·Phase: PHASE3
-
Dose Escalation and Expansion of Ziftomenib in Combination With Quizartinib in Acute Myeloid Leukemia
NCT06769490 ·Status: RECRUITING ·Phase: PHASE1
-
Study of NMS-03592088 in Patients With Relapsed or Refractory AML or CMML
NCT03922100 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
GM-CLAG in Relapsed/Refractory FLT3-mutated AML
NCT05330377 ·Status: WITHDRAWN ·Phase: PHASE1
-
Clofarabine and Gemtuzumab in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
NCT00577694 ·Status: TERMINATED ·Phase: PHASE1
-
Ipilimumab in Treating Patients With Relapsed or Refractory High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia
NCT01757639 ·Status: COMPLETED ·Phase: PHASE1
-
Cladribine in Combination With CAG in Patients With Refractory/Relapsed Acute Myeloid Leukemia
NCT03181815 ·Status: UNKNOWN ·Phase: PHASE2
-
Idarubicin + Cytarabine and Lenalidomide in Patients With Myelodysplastic Syndrome (MDS), Acute Myeloid Leukemia (AML)
NCT00831766 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Study of FF-10101-01 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
NCT03194685 ·Status: COMPLETED ·Phase: PHASE1
-
Phase II Study of Crenolanib in Subjects With Relapsed/Refractory AML With FLT3 Activating Mutations
NCT01522469 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Effectiveness Study of CPI-613 to Treat Refractory or Relapsed Leukemia and Myelodysplastic Syndrome
NCT01520805 ·Status: WITHDRAWN ·Phase: PHASE2
-
A Safety and Tolerability Study of Crenolanib in Combination With Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia Patients With FLT3 Mutations
NCT02283177 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Nemtabrutinib (MK-1026) in Participants With Relapsed or Refractory Hematologic Malignancies (ARQ 531-101/MK-1026-001)
NCT03162536 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Decitabine and Valproic Acid in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
NCT00079378 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase II Study of Crenolanib in Relapsed/Refractory Acute Myeloid Leukemia Patients With FLT3 Activating Mutations
NCT01657682 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Sabatolimab and Magrolimab-based Treatment in AML or Higher Risk MDS Participants
NCT05367401 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
GTI-2040 in Treating Patients With Relapsed, Refractory, or High-Risk Acute Leukemia, High-Grade Myelodysplastic Syndromes, or Refractory or Blastic Phase Chronic Myelogenous Leukemia
NCT00459212 ·Status: COMPLETED ·Phase: PHASE1
-
Lintuzumab-Ac225 in Combination with Cladribine + Cytarabine + Filgastrim + Mitoxantrone (CLAG-M) for Relapsed/Refractory Acute Myeloid Leukemia
NCT03441048 ·Status: COMPLETED ·Phase: PHASE1
-
Tipifarnib in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
NCT00101296 ·Status: COMPLETED ·Phase: PHASE1