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Study for Patients with Acute Myeloid Leukemia
The purpose of this study is to measure the safety of BST-236 and how effective it is in treating patients with newly-diagnosed acute myeloid leukemia (AML) who are not eligible for standard induction chemotherapy. The study drug, BST-236 is not approved by the FDA, and the use of BST-236 to treat acute myeloid leukemia is experimental. This will be done by administration of BST–236 (an investigational drug also called the study drug) 6 days in a row per cycle of treatment. The treatment cycles will be repeated up to 4 times during the study depending on your response to the treatment.
In order to participate you must meet the following criteria:
- Are an adult ≥18 years of age.
Have AML according to the 2016 revision to the World Health Organization (WHO) classification of myeloid neoplasms and acute leukemia: ≥20% blasts in peripheral blood or marrow:
- de-novo AML
- AML secondary to MDS
- AML secondary to exposure to potentially leukemogenic therapies or agents (e.g. radiation therapy, alkylating agents, topoisomerase II inhibitors) with the primary malignancy in remission for at least 2 years
Are not eligible for standard induction chemotherapy:
- Age ≥75 years
Age ≥18 years with at least one of the following comorbidities:
Clinically significant heart or lung comorbidities, as reflected by at least one of:
- Left ventricular ejection fraction (LVEF) ≤50%
- Lung diffusing capacity for carbon monoxide (DLCO) ≤65% of expected
- Forced expiratory volume in 1 second (FEV1) ≤65% of expected
- Chronic stable angina or congestive heart failure controlled with medication
- Other comorbidity that the Investigator judges as incompatible with intensive remission induction chemotherapy, which must be documented
- Clinically significant heart or lung comorbidities, as reflected by at least one of:
- Contraindication(s) to anthracycline therapy (must be documented)
- Have creatinine clearance (estimated by the Cockroft-Gault (C-G) measured by 24 hours urine collection) ≥45 mL/min.
- Have liver enzymes (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤2.5 times the upper limits of normal (ULN) if not attributed to leukemia or < 5 x ULN if related to leukemic involvement.
- Have total bilirubin ≤1.5 x ULN unless due to suspected history of Gilbert's disease.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status at screening: ≤3 for patient at the age of <75 years; ≤2 for patients at the age of ≥75 years.
- Are prepared and able to give written (signed and dated) informed consent, which includes compliance with study requirements and restrictions prior to admission to the study.
- Women of reproductive potential must have a negative serum pregnancy test within 48 hours of the first day of any BST-236 treatment course.
- Women or men of reproductive potential must use (or have his/her partner use) two forms of effective birth control methods starting from 1 month prior to screening and until 3 months following the last BST-236 administration day. (Acceptable methods of birth control in this study include: surgical sterilization, intrauterine devices, oral contraceptives, contraceptive patch, long-acting injectable contraceptives, partner’s vasectomy, or double-barrier method condom or diaphragm with spermicide)
- Voluntarily sign and date an ICF, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
Are able to adhere to the study visit schedule and other protocol requirements Inclusion criteria for reinduction treatment:
- Bone marrow morphological response (less than 25% blasts in BM or a reduction from baseline of at least 50% in BM blasts)
- Creatinine clearance (estimated by the C-G or measured by 24 hours urine collection) ≥45 mL/min during 48 hours prior to the first dose of reinduction
- Liver enzymes (AST and/or ALT) ≤2.5 x ULN if not attributed to leukemia or <5X ULN if related to leukemia involvement
- Total bilirubin ≤1.5 x ULN unless due to suspected history of Gilbert's disease
Inclusion criteria for consolidation treatment:
- Patient in CR/CRh/CRi.
- Creatinine clearance (estimated by the C-G or measured by 24 hours urine collection) ≥45 mL/min during 48 hours prior to the first dose of consolidation.
- Liver enzymes (AST and/or ALT) ≤2.5 x ULN.
- Total bilirubin ≤1.5 x ULN unless due to suspected history of Gilbert's syndrome.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.