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Table 2 Eligibility criteria for ABNL-MARRO 001

From: The ABNL-MARRO 001 study: a phase 1–2 study of randomly allocated active myeloid target compound combinations in MDS/MPN overlap syndromes

Inclusion Criteria

 • At least 18 years of age and willing and able to meet all study requirements

 • Morphologically confirmed diagnosis of MDS/MPN, excluding juvenile myelomonocytic leukemia, according to the WHO (2016) diagnostic criteria

 • Treatment-naïve patients with no prior disease-modifying therapy may enroll in any AM-001 arm that is open to accrual in phase1b or phase 2

 • After an appropriate wash-out period, patients who have failed or were intolerant to prior therapy regimens containing a DNMTi may enroll in any arm accruing in phase 1b or in the second stage of the phase 2

 • Willing to undergo bone marrow biopsy with aspiration and tissue collection for disease assessment and correlative studies during screening and periodically throughout the trial

 • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

 • Life expectancy of at least 3 months

 • For previously treated patients, recovery to Grade ≤ 1 or baseline of any toxicities due to prior systemic treatments, excluding alopecia

 • Adequate hepatic and renal function during screening

Exclusion Criteria

 • Patients will be excluded from arms that contain novel targeted agents to which they have prior exposure, with exception of ASTX727

 • Prior receipt of any investigational therapy within 30 days or 5 half-lives before receiving the first dose of AM-001 study therapy

 • Prior receipt of any systemic non-investigational antineoplastic therapy, excluding hydroxyurea, within 21 days or 5 half-lives before receiving the first dose of AM-001 therapy

 • Known hypersensitivity to decitabine

 • Transformation to acute myeloid leukemia

 • Organ transplant recipients including allogeneic hematopoietic stem cell transplant

 • History of clinically significant or uncontrolled cardiac disease

 • History of abnormal EKG or presence of abnormal screening EKG that is clinically significant and contraindicated for clinical study

 • Known contraindications to use of ASTX727

 • Active and clinically significant bleeding

 • Other active malignancy, excluding non-melanoma skin cancer, cervical carcinoma in situ, breast carcinoma in situ, or localized prostate cancer controlled with hormone therapy

 • Receipt of wide-field radiotherapy within 28 days or limited-field radiation within 14 days prior to initiating AM-001 treatment

 • Patients who require continuation of a prohibited concomitant medication

 • Active, uncontrolled infection

 • Major surgery requiring general anesthesia within 4 weeks prior to starting AM-001 therapy (other than placement/removal of vascular access devices)

 • Women who are pregnant or lactating

 • Women/men who expect to conceive/father children within the projected study period and/or who are unwilling to use highly effective methods of contraception throughout the study duration

 • Any concurrent serious or unstable medical or psychiatric condition that would jeopardize the patient’s ability to provide informed consent or to comply with the protocol

 • Any psychological, familial, geographical or sociological condition that would jeopardize the patient’s ability to comply with the study protocol