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Magrolimab Plus Intensive Chemotherapy in Newly Diagnosed AML or HR-MDS

NCT05829434 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-02-12

No results posted yet for this study

Summary

Use of magrolimab in combination with standard intensive chemotherapy ("7+3" or CPX-351) in newly diagnosed "ELN 2022 intermediate or adverse-risk" AML or high risk MDS patients, who intend to undergo allogeneic stem cell transplantation

Conditions

Interventions

DRUG

Magrolimab

Patients will receive magrolimab on day 1; 4: IV 1 mg/kg; day 8: IV 15 mg/kg; day 11, 15 and 22: IV 30 mg/kg (plus 30 mg/kg for 5 weeks weekly and then q2w until the end of consolidation)

DRUG

7+3

Patients will receive during Induction cycle 1: cytarabine at 100 mg/m² on study days 1-7 as a continuous infusion over 22-24 hours and daunorubicin at 60 mg/m² on study days 3, 4, 5 * optional during Induction cycle 2: cytarabine at 100 mg/m² on days 1-7 of the second induction cycle (i.e. study days 29-35) as a continuous infusion over 22-24 hours and daunorubicin at 60 mg/m² on days 3, 4, 5 of the second induction cycle (i.e. study days 31, 32, 33) * optional during Consolidation cycle: cytarabine at 1 g/m² administered on days 1, 3, 5 of each consolidation cycle as an infusion for 2 hours every 12 hours (for patients \< 60 years up to 3 CONS cycles and for patients ≥ 60 years up to 2 CONS cycles)

DRUG

CPX-351

Patients will receive during Induction cycle 1: CPX-351 with daunorubicin 44 mg/m² and cytarabine 100 mg/m² on days 1, 3, 5 * optional during Induction cycle 2: CPX-351 with daunorubicin 44 mg/m² and cytarabine 100 mg/m² on days 29 + 30 * optional during Consolidation cycle: CPX-351 with daunorubicin 29 mg/m² and cytarabine 65 mg/m² on days 1, 3

Sponsors & Collaborators

Principal Investigators

  • Uwe Platzbecker, Prof. Dr. · University of Leipzig

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-31
Primary Completion
2028-08-30
Completion
2029-08-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05829434 on ClinicalTrials.gov