Myeloid Leukemia Clinical Trial
Official title:
A Phase I/II Study of Gilteritinib and Momelotinib for Patients With Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia
To learn the recommended dose of momelotinib that can be given in combination with gilteritinib to participants with AML.
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 ;
| 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 | |
| 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 | |
| Recruiting |
NCT05035706 -
Anti-Leukemia Immune Responses After Irradiation of Extramedullary Tumors
|
Early Phase 1 |