Clinical Trials Logo

Clinical Trial Summary

To learn the recommended dose of momelotinib that can be given in combination with gilteritinib to participants with AML.


Clinical Trial Description

Primary Objectives - Phase I: To establish the minimum safe and biologically-effective dose of momelotinib in combination with gilteritinib in relapsed/refractory FLT3-mutated AML - Phase II: To determine the modified CRc rate of the regimen, including complete remission (CR), CR with incomplete hematologic recovery (CRi) or morphologic leukemia free state (MLFS) Secondary Objectives - To assess other efficacy endpoints (CR rate, measurable residual disease negativity by flow cytometry and FLT3 PCR, relapse-free survival, overall survival) - To assess proportion of participants proceeding to allogeneic hematopoietic stem cell transplantation - To determine the safety of the combination regimen Exploratory Objectives - To evaluate the impact of baseline genomic alterations on response and survival of the combination regimen - To determine the impact of baseline FLT3 allelic ratio on response and survival - To evaluate the pharmacokinetics (e.g. AUC, Cmax, Tmax and half-life) of momelotinib in the combination regimen - To evaluate changes in circulating cytokine levels in response to treatment - To evaluate inhibition of FLT3 signaling and inhibition of JAK/STAT signaling pathways - To evaluate other biomarkers associated with response and resistance to the combination regimen ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06235801
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Nicholas Short, MD
Phone (713) 563-4485
Email nshort@mdanderson.org
Status Recruiting
Phase Phase 1/Phase 2
Start date May 22, 2024
Completion date October 1, 2029

See also
  Status Clinical Trial Phase
Completed NCT00001637 - Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults Phase 2
Terminated NCT00543972 - Dose Escalation Safety and Pharmacokinetic Study of AVE9633 as Single Agent in Relapsed/Refractory CD33-Positive Acute Myeloid Leukemia Phase 1
Completed NCT00521664 - A Trial Comparing a Prophylactic With a Therapeutic Platelet Transfusion Strategy in Two Groups Phase 3
Completed NCT05363488 - Retrospective Observational Research Study to Describe the Real World Use of Bosutinib in a Single Centre in Scotland
Completed NCT01380756 - Study Evaluating Orally Administered AMG 900 in Adult Subjects With Acute Myeloid Leukemia Phase 1
Recruiting NCT05031897 - Reduced-Intensity Conditioning for the Prevention of Treatment-Related Mortality in Patients Who Undergo a Hematopoietic Stem Cell Transplant Phase 2
Terminated NCT00126893 - Study to Determine the Optimal Biologic Dose of CC-401 in Subjects With High-Risk Myeloid Leukemia Phase 1
Completed NCT03613727 - Therapeutic Use of Intravenous Vitamin C in Allogeneic Stem Cell Transplant Recipients Phase 2
Active, not recruiting NCT04714372 - FT538 in Combination With Daratumumab in AML Acute Myeloid Leukemia Phase 1
Completed NCT02763475 - NK Cells as Consolidation Therapy of Acute Myeloid Leukemia in Children/Adolescents Phase 2
Terminated NCT01643603 - Dasatinib for Immune Modulation After Donor Stem Cell Transplant for Hematologic Malignancies Phase 1
Completed NCT00497991 - Safety, Tolerability, PK and Efficacy of AZD1152 in Patients With Relapsed Acute Myeloid Leukemia Phase 1
Withdrawn NCT05309018 - Implantation of an Advanced Practice Nurse in the Complex Care Pathway of Patients With AML
Not yet recruiting NCT05787951 - Frequency and Risk Factors of Acute Myeloid Leukemia
Completed NCT04628338 - IFN-γ to Treat Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) That Has Relapsed After Allogeneic Hematopoietic Stem Cell Transplantation Early Phase 1
Completed NCT02719821 - Refining a Biobehavioral Intervention to Enhance Recovery Following Hematopoietic Stem Cell Transplantation N/A
Active, not recruiting NCT00111345 - Therapy-Optimization Trial for the Treatment of Acute Myeloid Leukemias (AML) in Children and Adolescents Phase 2/Phase 3
Completed NCT00114764 - Trial Comparing Pegfilgrastim With Filgrastim as an Adjunct to Chemotherapy for Acute Myeloid Leukaemia (AML) Phase 2
Recruiting NCT05871008 - Integrated Actionable Aging Assessment for Cancer Patients Pilot N/A
Recruiting NCT03638206 - Autologous CAR-T/TCR-T Cell Immunotherapy for Malignancies Phase 1/Phase 2