Phase
Condition
Leukemia
Treatment
VACl Alternating With VACh
VACh
VACl
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
A subject will be eligible for study participation if he/she meets the following criteria within 21 days prior to randomization.
Subject must have confirmation of previously untreated AML by World HealthOrganization (WHO) criteria, and be ineligible for treatment with a standardcytarabine and anthracycline induction regimen due age or comorbidities. Priortherapy with hydroxyurea or a total dose of cytarabine no more than 0.5g (foremergency use for stabilization) is allowed.
Subject must be≥18 years of age with at least one of the following conditions: A)≥60 years of age; B) Patients aged < 60 years who are unsuitable for standardinduction therapy(Any other comorbidity that the physician judges to be incompatiblewith conventional intensive chemotherapy); C) The patient refused the conventionalintensive chemotherapy.
Adequate organ function as defined below: A)liver function (bilirubin≤2mg/dL, aspartate transaminase (AST) and/or alaninetransaminase (ALT)≤3 x ULN). Unless liver enzyme abnormalities are determined by the treating MD and PI to be dueto leukemic infiltration. B)kidney function (creatinine≤1.5xULN ).
ECOG performance status of ≤ 2.
A negative urine pregnancy test is required within 1 week for all women ofchildbearing potential prior to enrolling on this trial.
Patient must have the ability to understand the requirements of the study and signedinformed consent. A signed informed consent by the patient or his legally authorizedrepresentative is required prior to their enrollment on the protocol.
Patient must have a projected life expectancy of at least 12 weeks.
Exclusion
Exclusion Criteria:
Subject has a history of other malignancies prior to study entry, with the exceptionof: A) Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ ofbreast; B) Basal cell carcinoma of the skin or localized squamous cell carcinoma ofthe skin; C) Previous malignancy confined and surgically resected (or treated withother modalities) with curative intent.
Subject has acute promyelocytic leukemia, subject has history of myeloproliferativeneoplasm [MPN] including myelofibrosis, essential thrombocythemia, polycythemiavera, CML with or without BCR-ABL1 translocation, BCR/ABL positive AML.
Patient has known active central nervous syster (CNS) involvement with AML.
Subject has a white blood cell count> 25×10^9/L. (Hydroxyurea is permitted to meetthis criterion.)
Prior therapy with venetoclax, Cladribine, hypomethylating agents (HMAs), Chidamideor Chimeric Antigen Receptor T cell therapy, experimental therapies for MDS or AML.
Subject has a malabsorption syndrome or other condition that precludes enteral routeof administration.
Subject is known to be positive for human immunodeficiency virus (HIV) (HIV testingis not required.)
Subject has received strong and/or moderate CYP3A inducers within 7 days prior tothe initiation of study treatment.
Subject has consumed grapefruit, grapefruit products, Seville oranges (includingmarmalade containing Seville oranges) or Starfruit within 3 days prior to theinitiation of study treatment.
Subject has a cardiovascular disability status of New York Heart AssociationClass≥2. Class 2 is defined as cardiac disease in which patients are comfortable atrest but ordinary physical activity results in fatigue, palpitations, dyspnea, oranginal pain.
Subject has chronic respiratory disease that requires continuous oxygen, orsignificant history of renal, neurologic, psychiatric, endocrinologic, metabolic,immunologic, hepatic, cardiovascular disease, or any other medical condition that inthe opinion of the investigator would adversely affect his/her participating in thisstudy.
Subject exhibits evidence of other clinically significant uncontrolled systemicinfection requiring therapy (viral, bacterial or fungal).
Subject is known to be positive for hepatitis B or C infection with the exception ofthose with an undetectable viral load within 3 months (Hepatitis B or C testing isnot required). Subjects with serologic evidence of prior vaccination to HBV [i.e.,HBs Ag-, and anti-HBs+-] may participate)
Study Design
Study Description
Connect with a study center
The First Affliated Hospital of Soochow University
Suzhou, Jiangsu 215006
ChinaActive - Recruiting
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