A Phase 1b/2 Study of Ropeginterferon Alfa-2b Added to Azacitidine in Newly Diagnosed MDS/AML (≥ 10% Blasts) With TP53 Mutations

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07646821
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Alfa-2b
  • Azacitidine
  • MDS/AML
  • Ropeginterferon

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ropeginterferon alfa- 2b — DRUG
    Given by iv
  • Azacitidine (AZA) — DRUG
    Given by IV

Study Details

To find the recommended dose of ropeginterferon alfa-2b in combination with azacitidine in patients with newly diagnosed MDS/AML with TP53 mutations. To learn if the recommended dose of ropeinterferon alfa-2b found in Dose Escalation in combination with azacitidine can help to control the disease.

Key Dates

Start date
Nov 27, 2026
Status verified
Jun 2026
Primary completion
Dec 11, 2028
Completion
Dec 11, 2030

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    Treatment with Ropeginterferon and AZA
  • Experimental: Dose Expansion,

Primary Outcome Measure

Safety and adverse events (AEs). [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Jayastu Senapati,, MD
[email protected]
713-745-9200
Jayastu Senapati, MD (PRINCIPAL_INVESTIGATOR)

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By research site
MD Anderson Cancer Center· Houston, TX