ISRCTN71474257
Terminated
Phase 2
A Phase II, randomised, open-label study evaluating the safety and efficacy of magrolimab in combination with venetoclax and azacitidine versus intensive chemotherapy in fit adults with high risk newly diagnosed acute myeloid leukaemia
DIDACT Foundation0 sites164 target enrollmentSeptember 14, 2023
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- DIDACT Foundation
- Enrollment
- 164
- Status
- Terminated
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. 18 to 70 years of age at the time of signing the Informed Consent Form (ICF)
- •2\. Able to provide written informed consent for the study
- •3\. Willing and able to adhere to the study visit schedule, treatment plan and other protocol requirements
- •4\. Newly diagnosed acute myeloid leukaemia (AML) (previously untreated for AML) and morphological confirmation of AML fulfilling European LeukaemiaNet (ELN) 2022 criteria
- •5\. Patients must be considered fit for intensive chemotherapy (IC) by the treating Investigator, using DA, DA\+GO, CPX\-351 (Vyxeos) or FLAG\-Ida, and have either:
- •5\.1\. Adverse risk AML as defined by the ELN 2022 criteria and be 18 to 70 years of age; OR
- •5\.2\. Intermediate risk AML according to the ELN 2022 criteria and be 50 to 70 years of age
- •6\. Genotype FLT3\-ITD mutation\-negative
- •7\. ECOG performance status 0\-2
- •8\. Adequate renal function, as demonstrated by serum creatinine \=1\.5 x upper limit of normal (ULN)
Exclusion Criteria
- •1\. Have received previous cytotoxic chemotherapy (intensive or non\-intensive), targeted therapies, hypomethylating agents or venetoclax for AML or any other antecedent haematological condition, with the exception of hydroxycarbamide to control white blood cell (WBC) count or lenalidomide for treatment of myelodysplasia (MDS) 5q syndrome
- •2\. Have received prior treatment with CD47 or signal regulatory protein alpha\-targeting agents
- •3\. Are in blastic transformation of chronic myeloid leukaemia (CML)
- •4\. Clinical suspicion of active central nervous system (CNS) involvement with AML
- •5\. Are not deemed fit for intensive chemotherapy (IC) on the basis of age or comorbidities
- •6\. Have secondary malignancy, except MDS, treated basal cell carcinoma or localised squamous skin carcinomas, localised prostate cancer, or other malignancies for which patients are not on active anti\-cancer therapies and have had no evidence of active malignancy for at least 1 year. Note: patients on maintenance therapy alone, who have no evidence of active malignancy for at least 1 year are eligible
- •7\. Have acute promyelocytic leukaemia (APL)
- •8\. Known newly diagnosed or uncontrolled human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection. Patients with known chronic infections may enrol if the last two tests for viral load have been negative and their current therapy does not include a protease inhibitor or a non\-nucleoside reverse\-transcriptase inhibitor
- •9\. Significant disease or medical conditions, as assessed by the Investigator, that would substantially increase the risk\-benefit ratio of participating in the study. This includes, but is not limited to:
- •9\.1\. Acute myocardial infarction within 6 months of randomisation,
Outcomes
Primary Outcomes
Not specified
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