AML Clinical Trial
Official title:
A Phase 1-2, Dose Escalation, Multicenter Study of Two Subcutaneous Regimens of SGI-110, a DNA Hypomethylating Agent, in Subjects With Intermediate or High-Risk Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML)
Phase 1-2 dose escalation randomized study in patients with intermediate or high risk myelodysplastic syndromes (MDS) or acute myelogenous leukemia (AML). The Dose Escalation Segment will evaluate the biological activity, preliminary safety and efficacy of SGI-110 with two dosing schedules in MDS and AML patients while the Dose Expansion Segment will further evaluate safety and efficacy at the biological effective dose (BED) or maximum tolerated dose (MTD)as defined in the Dose Escalation Segment.
Once the BED and MTD is determined in the Dose Escalation Segment, the Dose Expansion Segment will randomize patients with MDS, treatment naïve elderly AML, and relapsed/refractory AML patients to receive the BED or MTD dose. Relapsed/refractory AML patients may also receive SGI-110 on a daily x 10 schedule based on the total dose per cycle evaluated in the Dose Escalation Segment using the 5-daily regimen. ;
| 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| Withdrawn |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| Withdrawn |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 |
NCT00246649 -
Stem Cell Transplant With Specially Treated Cells in Treating Patients With Acute Leukemia
|
N/A | |
| Completed |
NCT00333190 -
CD8+ T Cell Depletion for GVHD Prophylaxis After Peripheral Blood Stem Cell Transplantation
|
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| Withdrawn |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 |
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 |
NCT00780598 -
Safety and Anti-Disease Activity of Oral Tosedostat (CHR-2797) in Elderly Subjects With Refractory or Relapsed AML
|
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 |