AML Clinical Trial
Official title:
A Phase II Single-arm Open-labeled Study Evaluating Combination of Sorafenib and Omacetaxine Mepesuccinate in Newly Diagnosed or Relapsed/Refractory AML Carrying FLT3-ITD
The study aims to test if combination of sorafenib and omacetaxine mepesuccinate (OM, also known as homoharringtonine) results in durable composite complete remission (CRc) in patients with newly diagnosed or relapsed/refractory (R/R) acute myeloid leukemia (AML) carrying FLT3-ITD (Fms-Like Tyrosine Kinase 3 - Internal Tandem Duplication).
The type of AML being studied in this clinical trial is known as FMS-like tyrosine kinase 3
(FLT3)-internal tandem duplication (ITD) positive AML. This type of AML has an alteration (or
mutation) in genes, which may associated with high risk of relapse after conventional
chemotherapy and hence an extremely poor clinical outcome.
FLT3 inhibitors including sorafenib are effective in inducing remission. However, their
effects are only transient. There is an unmet clinic need to enhance their effectiveness,
hence clinical application.
This is a Phase II single-arm open-labeled study. A total of 40 eligible patients with
consent will be recruited, including 20 patients with newly diagnosed and 20 with R/R
FLT3-ITD AML.
For newly diagnosed patients, diagnostic bone marrow (BM) and/or peripheral blood (PB) will
be evaluated by next generation sequencing (NGS) based on myeloid panel that comprises 54
myeloid genes as well as their in vitro response to sorafenib and omacetaxine mepesuccinate
(OM) based on an in-house platform that was established in our laboratory. FLT3-ITD allelic
burden will also be evaluated.
For R/R patients, FLT3-ITD status and allelic burden will be confirmed before treatment. Both
groups of patients will receive sorafenib 400 mg twice daily continuously and OM 1.5 mg/m2
daily for 7 days every 28 days until progression or allogeneic hematopoietic stem cell
transplantation (HSCT). Thereafter, patients will be followed up and information about
disease status and survival will be collected. BM examination will be performed on day 28 to
document morphological response and FLT3-ITD allelic burden.
At leukemia progression, BM and/or PB samples will be collected and their in vitro response
to sorafenib and OM examined. The tyrosine kinase domain (TKD) of FLT3 will also be sequenced
and FLT3-ITD allelic burden will be evaluated.
;
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 |