Last updated: November 27, 2023
Sponsor: Sheba Medical Center
Overall Status: Active - Recruiting
Phase
2
Condition
Leukemia
Treatment
Bisantrene
Fludarabine
Clofarabine
Clinical Study ID
NCT04989335
RAC-002
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved writtenInformed Consent and privacy language as per national regulations.
- Age 18 -65 (inclusive) years
- Diagnosis of AML by World Health Organization (WHO) classification (WHO, 2016) andhave received at least one line of therapy prior to enrollment into this study.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.0
- Life expectancy ≥ 3 months.
- Adequate organ function as evidenced by serum total bilirubin ≤ 2.0 mg/dL, alanineaminotransferase (ALT) or aspartate aminotransferase (AST) ≤4 × the upper limit ofnormal (ULN), serum albumin >2.8 g/dL, serum creatinine ≤2 mg/dL.
- Cardiac ejection fraction ≥50%, assessed by 2-Dimensional echocardiogram.
- Pulmonary function ≥50% assessed by diffusing capacity for carbon monoxide (DLCO), andany clinically significant decrease in DLCO must not be caused by infection.
- Negative for serum markers for HIV, Hepatitis -B, -C, and HTLV-1
- Clinically significant non-hematologic toxicity after prior chemotherapy has recoveredto Grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
- Females must be surgically or biologically sterile or postmenopausal (amenorrhoeic forat least 12 months) or if of childbearing potential, must have a negative urine orserum pregnancy test within 14 days before study entry, and must agree to use anadequate method of contraception, i.e. barrier method, during the study until 30 daysafter the last treatment. Males must be surgically or biologically sterile or agree touse an adequate method of contraception, i.e. barrier method, during the study until 30 days after the last treatment.
Exclusion
Exclusion Criteria:
- Acute promyelocytic leukemia (APML, APL) M3 subtype of AML.
- Other active malignancy (including other hematologic malignancies) or other malignancywithin the last 12 months except non-melanoma skin cancer or cervical intraepithelialneoplasia.
- Prior or current therapy:
- Hydroxyurea or other oral medications to reduce blast count within 72 hoursbefore the first dose of study drug
- Treatment with an investigational agent within 14 days before the first dose ofstudy drug, or not recovered from all acute effects of previous investigationaltherapy
- Last treatment was with a drug of long elimination half-life (e.g. enasidenib),as such a wash out period 5x elimination half-life is necessary prior toenrollment
- For patients who have undergone hematopoietic stem cell transplantation (HSCT),procedure-related medications (e.g. immunosuppressive therapy) administered within 2weeks prior to first dose of study drug.
- Any medical, psychological, or social condition that may interfere with studyparticipation or compliance or may compromise the patient's safety in the opinion ofthe investigator.
Study Design
Total Participants: 29
Treatment Group(s): 3
Primary Treatment: Bisantrene
Phase: 2
Study Start date:
August 02, 2021
Estimated Completion Date:
December 01, 2025
Connect with a study center
Chaim Sheba Medical Center
Ramat Gan, 57261
IsraelActive - Recruiting
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