AML Clinical Trial
Official title:
Epacadostat With Cladribine and Cytarabine (ECC) in Relapsed / Refractory AML Patients Fit for Intensive Chemotherapy; a Phase I Study.
This trial assess the maximum tolerated dose (MTD) and to characterize dose-limiting toxicities (DLTs) of epacadostat when added to the cladribine/cytarabine chemotherapy in relapsed / refractory AML patients fit for intensive treatment
Background and Rationale:
Epacadostat (INCB024360) is an Inhibitor of Indoleamine 2,3- dioxygenase 1 (IDO1).
Indoleamine 2,3- dioxygenase 1 (IDO1) is a 403 amino acid cytosolic haem enzyme encoded by
the INDO gene on human chromosome 8p22. IDO1 is responsible for the catabolism of the
essential amino acid tryptophan (trp) to kynurenine (kyn) within immune cells and a subset of
tumor cells resulting in inhibition of antitumor cell-mediated immune responses. Increased
IDO activity correlates with lower CR rates and shorter OS in AML.
Objective:
The primary objective is to determine the maximum tolerated dose (MTD) and to characterize
dose-limiting toxicities (DLTs) of epacadostat when added to the cladribine/cytarabine
chemotherapy in relapsed / refractory AML patients fit for intensive treatment
Study Duration:
Phase I part will last from 3 to 18 months (permitting the enrolment of minimum of 3 and a
maximum of 24 patients).
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03118466 -
Mitoxantrone, Etoposide, and Cytarabine (MEC) Plus Lenalidomide for Relapsed or Refractory Acute Myeloid Leukemia
|
Phase 2 | |
| Not yet recruiting |
NCT06313437 -
Revumenib in Combination With 7+3 + Midostaurin in AML
|
Phase 1 | |
| Withdrawn |
NCT03444649 -
Epacadostat, Idarubicin and Cytarabine (EIC) in AML
|
Phase 1 | |
| Withdrawn |
NCT02905994 -
Volasertib Combined With Induction Chemotherapy in Acute Myeloid Leukemia
|
Phase 1 | |
| Recruiting |
NCT02261779 -
Phase I/II Trial of ATRA and TCP in Patients With Relapsed or Refractory AML and no Intensive Treatment is Possible
|
Phase 1/Phase 2 | |
| Completed |
NCT00333190 -
CD8+ T Cell Depletion for GVHD Prophylaxis After Peripheral Blood Stem Cell Transplantation
|
N/A | |
| Completed |
NCT00246649 -
Stem Cell Transplant With Specially Treated Cells in Treating Patients With Acute Leukemia
|
N/A | |
| Terminated |
NCT04079738 -
Study Augmenting TAK-659 Action in Relapsed/Refractory AML by Addition Ofthe Proteasome Inhibitor Ixazomib
|
Phase 1/Phase 2 | |
| Completed |
NCT03466320 -
DEPLETHINK - LymphoDEPLEtion and THerapeutic Immunotherapy With NKR-2
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT03138395 -
iCare3: Monitoring Circulating Cancer DNA After Chemotherapy in MDS and AML
|
N/A | |
| Terminated |
NCT01570465 -
Prospective Study on Severe Infections on Acute Myeloid Leukemia (AML) Patients
|
||
| Completed |
NCT04443751 -
A Safety and Efficacy Study of SHR-1702 Monotherapy in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
|
Phase 1 | |
| Terminated |
NCT03761069 -
Study of PTC299 (Emvododstat) in Relapsed/Refractory Acute Leukemias
|
Phase 1 | |
| Completed |
NCT02631993 -
Photochemotherapy and Graft-versus-leukemia in Acute-leukemia
|
N/A | |
| Completed |
NCT02575963 -
Lintuzumab-Ac225 in Older Acute Myeloid Leukemia (AML) Patients
|
Phase 1/Phase 2 | |
| Completed |
NCT00780598 -
Safety and Anti-Disease Activity of Oral Tosedostat (CHR-2797) in Elderly Subjects With Refractory or Relapsed AML
|
Phase 2 | |
| Completed |
NCT00863148 -
Allogeneic Stem Cell Transplant With Clofarabine, Busulfan and Antithymocyte Globulin (ATG) for Adult Patients With High-risk Acute Myeloid Leukemia/Myelodysplastic Syndromes (AML/MDS) or Acute Lymphoblastic Leukemia (ALL)
|
Phase 2 | |
| Completed |
NCT00542971 -
Phase I-II Study of Idarubicin, Cytarabine, and Sorafenib (BAY43-9006)
|
Phase 1/Phase 2 | |
| Completed |
NCT00761449 -
Lenalidomide in High-risk MDS and AML With Del(5q) or Monosomy 5
|
Phase 2 | |
| Completed |
NCT00589082 -
DaunoXome + Ara-C vs Daunorubicin + Ara-C in Elderly AML
|
Phase 3 |