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Monoclonal Antibodies

Axatilimab + Azacitidine for Myeloid Leukemia

Phase 1 & 2

Recruiting

Led By Uma M Borate, MD

Research Sponsored by Uma Borate

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

eGFR ≥ 30 mL/min/1.73m^2

Must not have

History of myositis

Diagnosis of AML including acute promyelocytic leukemia and extra-medullary AML based on WHO 2016 classification

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the best dose of a drug called axatilimab and how effective it is when used alone or with another drug called azacitidine for treating patients with certain types of

Who is the study for?

This trial is for patients with advanced myeloproliferative neoplasms, overlap of myelodysplastic syndrome and myeloproliferative neoplasm, or high-risk chronic myelomonocytic leukemia. Specific eligibility criteria are not provided but typically include factors like age, disease stage, and overall health.

What is being tested?

The trial is testing the effectiveness of axatilimab alone or combined with azacitidine in treating certain blood cancers. Axatilimab blocks proteins that may be involved in cancer growth; azacitidine slows down cancer cell growth.

What are the potential side effects?

Possible side effects are not detailed here but generally could include reactions at the infusion site, fatigue, nausea, low blood counts leading to increased infection risk or bleeding tendencies due to axatilimab and azacitidine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can care for myself and am up and about more than 50% of my waking hours.

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My kidney function is normal or mildly reduced.

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I was diagnosed with PV, ET, or PMF and my condition has worsened despite treatment.

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My condition is either MDS/MPN-RS-T or MDS/MPN-SF3B1-T.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of myositis.

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I have been diagnosed with a type of leukemia called AML.

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I am eligible for or have declined intensive chemotherapy.

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I have had an organ or stem cell transplant.

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I have a history of pancreatitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of dose limiting toxicities

Overall response rate

Secondary study objectives

Incidence of adverse events

Number of packed red blood cell transfusions

Number of platelet transfusions

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase II (Axatilimab and azacitidine)Experimental Treatment5 Interventions

Patients receive axatilimab IV over 30 minutes on days 1 and 15 and azacitidine IV over 10-40 minutes or SC on days 1-7 of each cycle. Cycles repeat every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve PR or better may continue for up to 24 total cycles. Patients who achieve less than PR receive 2 additional cycles and, if PR or better is achieved, may complete up to 24 total cycles. Patients undergo bone marrow biopsy and aspiration and blood sample collection throughout the study.

Group II: Phase I (Axatilimab)Experimental Treatment3 Interventions

Patients receive axatilimab IV over 30 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. At time of phase Ib completion, patients with clinical improvement may transition to phase II. Patients undergo bone marrow biopsy and aspiration and blood sample collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Axatilimab

2017

Completed Phase 1

~50

Azacitidine

2012

Completed Phase 3

~1440