Clinical Trials Logo

Clinical Trial Summary

This is a prospective, single-arm, multi-center clinical trial to evaluate the efficacy and safety of selinexor in combination with azacitidine and venetoclax for untreated acute myeloid leukemia based on MRD results on day 14 of the first cycle.


Clinical Trial Description

Azacitidine and Venetoclax will be given at the approved dose regimen for 75mg/m2, d1-7(azacitidine) and 100mg on day 1 and 200mg on day 2, 400mg on day 3-28 (venetoclax), 28 days per cycle. Based on MRD results on C1D14, MRD negative patients will go on azacitidine and venetoclax regimen and for patients with MRD positive, selinexor 60mg on D15 and D22 will be added. Patients can receive transplants at any time once they achieved complete remission and other patients will continue to receive treatment until disease progression or unacceptable toxic effects. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05736978
Study type Interventional
Source Shanghai Tong Ren Hospital
Contact Ligen Liu, MD
Phone 18017337037
Email liuligen@shsmu.edu.cn
Status Recruiting
Phase Phase 2
Start date March 31, 2023
Completion date March 15, 2027

See also
  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Withdrawn NCT03444649 - Epacadostat, Idarubicin and Cytarabine (EIC) in AML Phase 1
Withdrawn NCT02905994 - Volasertib Combined With Induction Chemotherapy in Acute Myeloid Leukemia Phase 1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Withdrawn NCT03138395 - iCare3: Monitoring Circulating Cancer DNA After Chemotherapy in MDS and AML N/A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 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