MedTrace Logo

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.

NCT05201066 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-01-07

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

decitabine

Solution for intravenous infusion

DRUG

spartalizumab

Solution for intravenous infusion

DRUG

sabatolimab

Solution for intravenous infusion

DRUG

azacitidine

Solution for subcutaneous injection or intravenous infusion

DRUG

venetoclax

Tablet for oral administration

DRUG

INQOVI (oral decitabine)

Tablet for oral administration. HMA = azactidine or decitabine INQOVI = decitabine (oral)

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-13
Primary Completion
2028-02-14
Completion
2028-02-14
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • China
  • Czechia
  • France
  • Germany
  • Greece
  • Italy
  • Japan
  • Malaysia
  • Spain
  • Switzerland
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT05201066 on ClinicalTrials.gov