A Study of Oral Decitabine/Cedazuridine in Combination With Magrolimab in Participants With Intermediate- to Very High-Risk Myelodysplastic Syndromes (MDS)

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Astex Pharmaceuticals, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new combination of drugs to treat cancer. It uses decitabine/cedazuridine to stop cancer cells from growing and magrolimab to help the immune system destroy them. The goal is to see if this combination is safe and effective for patients who may not respond to usual treatments.

Research Team

Eligibility Criteria

Inclusion Criteria

Overall Revised International Prognostic Scoring System for myelodysplastic syndromes (IPSS-R) score ≥3.5 MDS (immediate risk or higher).

Hematopoietic stem cell transplant (HSCT) eligible without any pre-arranged HSCT on Cycle 1 Day 1, or HSCT ineligible.

Histological confirmation of previously untreated MDS (i.e., no hypomethylating agent [HMA], chemotherapy, or allogenic stem cell transplant [SCT] per World Health Organization 2016 classification with <20% bone marrow (BM) blasts per marrow biopsy/aspirate at screening.

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Exclusion Criteria

You have known or suspected allergies to decitabine, cedazuridine, magrolimab, or any of the ingredients in these medications.

There is a strong belief that your central nervous system (brain and spinal cord) is currently affected by a condition called MDS.

Known significant mental illness or other condition such as active alcohol or other substance abuse or addiction that, in the opinion of the investigator, predisposes the participant to high-risk of noncompliance with the protocol.

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Treatment Details

Interventions

Decitabine/Cedazuridine (Anti-metabolites)
Magrolimab (Monoclonal Antibodies)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Oral Decitabine/Cedazuridine + MagrolimabExperimental Treatment2 Interventions

Participants will receive 35 milligrams (mg) decitabine/100 mg cedazuridine as a fixed dose combination (FDC) tablet, orally, once daily (QD) on Days 1-5 of each 28-day cycle in combination with magrolimab, intravenous (IV) infusion of 1 milligrams per kilogram (mg/kg) on Days 1 and 4, 15 mg/kg on Day 8, 30 mg/kg on Days 11, 15, 22, 29, 36, 43, and 50, followed by a maintenance dose of 30 mg/kg on Day 57 and every 14 days thereafter until toxicity, progressive disease, withdrawal, death or end of study (approximately 44 months).