AML Clinical Trial
Official title:
A Phase II Single-arm Open-labeled Study Evaluating Combination of Quizartinib and Omacetaxine Mepesuccinate (QUIZOM) in Newly Diagnosed or Relapsed/Refractory AML Carrying FLT3-ITD
Verified date | December 2020 |
Source | The University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study aims to test if combination of quizartinib (AC220) 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).
Status | Active, not recruiting |
Enrollment | 40 |
Est. completion date | October 1, 2021 |
Est. primary completion date | October 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Provision of written informed consent approved by the Institutional Review Board (IRB). 2. Age =18 years 3. Documented primary AML or AML secondary to myelodysplastic syndrome (MDS), as defined by World Health Organization criteria 4. At diagnosis or in morphological relapse after an initial remission or refractory after induction chemotherapy, with or without HSCT 5. Documentation of FLT3-ITD in BM or blood with allelic burden of = 20% as determined by the study site laboratory 6. ECOG performance score 0-2 7. Discontinuation of prior AML treatment = 2 weeks before the start of QUIZOM (except hydroxyurea or other treatment to control leukocytosis). 8. Serum creatinine =1.5×upper limit of normal (ULN), or glomerular filtration rate >25 mL/min, as calculated with the Cockcroft-Gault formula. 9. Serum potassium, magnesium, and calcium (corrected for albumin) within institutional normal limits. Subjects with electrolytes outside the normal range will be eligible if these values are corrected upon retesting following any necessary supplementation. 10. Total serum bilirubin =1.5×ULN. 11. Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) = 2.5×ULN. Exclusion Criteria: 1. Acute promyelocytic leukemia (AML subtype M3) 2. Prior treatment with any FLT3 inhibitors 3. Known infection with human immunodeficiency virus, or active hepatitis B or C infection. 4. Refusal of blood product transfusion. 5. Uncontrolled or significant cardiovascular disease, including: i. QTcF interval > 450 msec ii. Bradycardia of = 50 BPM iii. Diagnosed or suspected long QT syndrome, or known family history of long QT syndrome iv. History of clinically relevant ventricular arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or torsade de pointes v. History of second or third degree heart block. Candidates with a history of heart block may be eligible if they currently have pacemakers, and have no history of fainting or clinically relevant arrhythmia with pacemakers. vi. Myocardial infarction within 6 months prior to screening vii. Uncontrolled angina pectoris within 6 months prior to screening viii. New York Heart Association (NYHA) Class 3 or 4 congestive heart failure ix. Uncontrolled hypertension x. Complete left or right bundle branch block 6. In a man whose sexual partner is a woman of childbearing potential, unwillingness or inability of the man or woman to use an acceptable contraceptive method for the entire study treatment period and for at least 3 months after study treatment completion 7. In a heterosexually active woman of childbearing potential, unwillingness or inability to use an acceptable contraceptive method for the entire study treatment period and for at least 3 months after study treatment completion 8. Pregnancy 9. Female subjects must agree not to breastfeed at screening and throughout the study period, and for 45 days after the final study drug administration. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | The University of Hong Kong | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete remission | No increase in blasts in BM or PB (<5% of total nucleated cells), with absolute neutrophil count = 1x109/L and platelet count = 100 x109/L | up to 16 weeks |
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 |
NCT00761449 -
Lenalidomide in High-risk MDS and AML With Del(5q) or Monosomy 5
|
Phase 2 | |
Completed |
NCT00542971 -
Phase I-II Study of Idarubicin, Cytarabine, and Sorafenib (BAY43-9006)
|
Phase 1/Phase 2 | |
Terminated |
NCT00176930 -
Stem Cell Transplant for Hematological Malignancy
|
N/A |