Acute Myeloid Leukemia, in Relapse Clinical Trial
Official title:
An Escalation/Expansion, Open Label, Multicenter Study of Iadademstat and Gilteritinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML) With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+): The FRIDA Study
Iadademstat is being studied as a treatment for subjects with Relapsed or Refractory Acute Myeloid Leukemia (R/R AML) with FMS-like tyrosine kinase mutation (FLT3 mut+). During the trial, iadademstat will be given in combination with gilteritinib, a drug that is already approved to treat patients with FLT3-mutated R/R AML.
This is an escalation/expansion, open label, single arm, study to investigate the safety and the RP2D of the combination of iadademstat with gilteritinib in FLT3-mutated R/R AML. This study consists of 2 parts. A dose finding part to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and emerging activity of iadademstat and gilteritinib combination, and to determine the pharmacologically-active dose (i.e., the minimum safe and biologically active dose) of iadademstat in combination with gilteritinib, and an expansion part at the specific dose/s selected to evaluate the activity of iadademstat in combination with gilteritinib in patients with FLT3-mutated R/R AML. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT02204085 -
A Phase I/II Trial of the MUC1 Inhibitor, GO-203-2C in Patients With Relapsed or Refractory Acute Myeloid Leukemia
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06125652 -
Administration of Anti Tim-3/CD123 CAR-T Cell Therapy in Relapsed and Refractory Acute Myeloid Leukemia (rr/AML)
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05105152 -
PLAT-08: A Study Of SC-DARIC33 CAR T Cells In Pediatric And Young Adults With Relapsed Or Refractory CD33+ AML
|
Phase 1 | |
| Recruiting |
NCT05597306 -
Venetoclax and Bomedemstat in Patients With Relapsed/Refractory Acute Myeloid Leukemia
|
Phase 1 | |
| Recruiting |
NCT04898894 -
Study of Selinexor and Venetoclax in Combination With Chemotherapy in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia
|
Phase 1 | |
| Recruiting |
NCT03957915 -
Study of Escalating Doses of INA03 Administered Intravenously as Single Agent in Adult Patients With Relapse/Refractory Acute Leukemia
|
Early Phase 1 | |
| Recruiting |
NCT05317403 -
Venetoclax to Augment Epigenetic Modification and Chemotherapy
|
Phase 1 | |
| Recruiting |
NCT04867928 -
Venetoclax and Azacitidine for the Management of Molecular Relapse/Progression in Adult NPM1-mutated Acute Myeloid Leukemia
|
Phase 2 | |
| Completed |
NCT04402541 -
Study of CB-5339 in Acute Myeloid Leukemia or Myelodysplastic Syndrome
|
Phase 1 | |
| Not yet recruiting |
NCT04716452 -
Study of C6 Ceramide NanoLiposome (CNL) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
|
Phase 1 | |
| Recruiting |
NCT05211570 -
AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
|
Phase 1/Phase 2 | |
| Terminated |
NCT03690154 -
A Phase 1 Study to Evaluate FN-1501 Monotherapy in Patients With Advanced Solid Tumors and R/R AML
|
Phase 1 | |
| Recruiting |
NCT05735184 -
A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, or 7+3 in Patients With AML
|
Phase 1 | |
| Recruiting |
NCT05124288 -
Analysis of the Immunobiology of Acute Myeloid Leukemia Relapses After Allogeneic Hematopoietic Stem Cell Transplant (HSCT) for the Generation of Guidelines and Personalized Therapeutic Pathways
|
||
| Recruiting |
NCT05506332 -
Treatment With ABT-199 (Venetoclax) and Purine Analogues in Relapsed/Refractory Acute Myeloid Leukemia
|
Phase 1 | |
| Recruiting |
NCT05949125 -
Dose-escalating Trial With Allo-RevCAR01-T Cells in Combination With CD123 Target Module (R-TM123) for Participants With Selected Hematologic Malignancies Positive for CD123
|
Phase 1 | |
| Recruiting |
NCT06128044 -
CRISPR-Edited Allogeneic Anti-CLL-1 CAR-T Cell Therapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia
|
Phase 1 | |
| Completed |
NCT04321161 -
Analysis of T Cell Metabolism in Relapsed AML Patients With DLIs and Bicanorm Treatment
|
Early Phase 1 | |
| Not yet recruiting |
NCT06281847 -
An Adaptive Open-label Multicentre Phase 1/2 Trial, to Determine the Recommended Phase 2 Dose of CCTx-001, and to Assess Safety, Tolerability, and Clinical Activity in Patients With Relapsed/Refractory Acute Myeloid Leukaemia
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04678336 -
CD123 Redirected T Cells for AML in Pediatric Subjects
|
Phase 1 |