Roll-over Study for Patients Who Have Completed a Prior Novartis-sponsored Sabatolimab (MBG453) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Sabatolimab.

Part of paid clinical trials in Portland, Oregon.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05201066
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Leukemia, Myelomonocytic, Chronic
  • Myelodysplastic Syndromes

Eligibility Criteria

Sex
ALL
Age
12 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • decitabine — DRUG
    Solution for intravenous infusion
  • spartalizumab — DRUG
    Solution for intravenous infusion
  • sabatolimab — DRUG
    Solution for intravenous infusion
  • azacitidine — DRUG
    Solution for subcutaneous injection or intravenous infusion
  • venetoclax — DRUG
    Tablet for oral administration
  • INQOVI (oral decitabine) — DRUG
    Tablet for oral administration. HMA = azactidine or decitabine INQOVI = decitabine (oral)

Study Details

This study is intended to collect safety data from participants who completed the parent protocols but are still benefiting from study treatment. The study population consists of participants who tolerate study treatment of the parent studies. Collecting safety information from long-term exposure might offer the unique opportunity to detect rare Adverse Events.

Key Dates

Start date
Feb 13, 2023
Status verified
Jan 2026
Primary completion
Feb 14, 2028
Completion
Feb 14, 2028

Study Design

Enrollment
33 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: sabatolimab + azacitidine
    Patients will take sabatolimab 800 mg i.v and azacitidine 75 mg/m2/d d1-7 s.c. or i.v./q4w or sabatolimab 400 mg i.v/q2w and azacitidine 75 mg/m2/d d1-7 s.c. or i.v./q4w.
  • Experimental: sabatolimab + decitabine
    Patients will take Sabatolimab 400 mg i.v/q2w and decitabine 20 mg/m2/d d1-5 i.v.
  • Experimental: sabatolimab + venetoclax + azacitidine
    Patients will take sabatolimab 200 mg i.v./q2w and venetoclax 400 mg p.o. d1-14/q4wk and azacitidine 75 mg/m2/d d1-7/q4w.
  • Experimental: sabatolimab + spartalizumab + decitabine
    Patients will take sabatolimab 400 mg i.v./q2w and decitabine 20 mg/m2/d d1-5 i.v. and spartalizumab 100 mg i.v/q2w.
  • Experimental: sabatolimab + HMA
    Patients will take sabatolimab 800 mg and azacitidine 75 mg/m2/d d1-7 or decitabine 20 mg/m2/d d1-5/ all q4w HMA means hypomethylating agents. Hypomethylating agents are azacitidine and decitabine.
  • Experimental: sabatolimab
    Patients will take sabatolimab 800 mg i.v q4w.

Primary Outcome Measure

Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 5 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Oregon Health Sciences UniversityPortlandOregon97239-
Huntsman Cancer Institute Univ of UtahSalt Lake CityUtah84112 0550-

Find similar trials in Portland, OR

By research site
Oregon Health Sciences University· Portland, ORHuntsman Cancer Institute Univ of Utah· Salt Lake City, UT

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