Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Japan / NCT05201066
Active, not recruiting Phase 2

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 · tracked via the Priya Life Science Japan tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 2
Started
2023-02-28
Last updated
2026-09-22

Condition(s) studied

Myelodysplastic SyndromesLeukemia, Myelomonocytic, Chronic

Investigational drug(s) / intervention(s)

decitabine →spartalizumab →sabatolimabazacitidine →venetoclax →INQOVI (oral decitabine) →

decitabine: Solution for intravenous infusion

spartalizumab: Solution for intravenous infusion

sabatolimab: Solution for intravenous infusion

azacitidine: Solution for subcutaneous injection or intravenous infusion

venetoclax: Tablet for oral administration

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

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.

Eligibility

Sex
ALL
Min age
12 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria: 1. Participant is currently enrolled in a Novartis-sponsored study with sabatolimab, is being treated with sabatolimab, and has fulfilled all requirements in the parent study. 2. Participant is currently benefiting from the treatment with sabatolimab as determined by guidelines of the parent protocol and investigator's judgment. 3. Participant has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements. 4. Willingness and ability to comply with scheduled visits, treatment plan and any other study procedures. 5. Written informed consent obtained prior to enrolling in the roll-over study. Exclusion Criteria: 1. Participants in cohorts or treatment groups not receiving sabatolimab in the parent protocol. 2. Participant has been permanently discontinued from sabatolimab treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason. 3. Participant currently has unresolved toxicities for which sabatolimab dosing has been interrupted in the parent study (participants meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow sabatolimab dosing to resume). 4. Pregnant or nursing (lactating) women. Where pregnancy is defined as the state of a female after conception confirmed by a positive serum hCG laboratory test and until the termination of gestation. 5. Participant not willing to comply with the contraception requirements outlined in the exclusion criteria of the parent protocol. 6. Local access to commercially available sabatolimab for parent protocol indications. Other protocol-defined Inclusion/Exclusion may apply.

Primary outcome measure(s)

  • Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) — 5 years
    An AE is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. An AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product. An SAE is defined as any adverse event \[appearance of (or worsening of any pre-existing)\] undesirable sign(s), symptom(s), or medical conditions(s) which meets any one of the following criteria: fatal, life-threatening, results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, may have caused a congenital anomaly/birth defect, requires intervention to prevent permanent impairment or damage.
  • Severity of AEs and SAEs — 5 years
    Severity of AEs and SAEs will be measured according to the CTCAE v5.0

Trial sites (24)

FacilityCityRegionStatus
Oregon Health Sciences University Portland Oregon
Huntsman Cancer Institute Univ of Utah Salt Lake City Utah
Novartis Investigative Site Clayton Victoria
Novartis Investigative Site Florianópolis Santa Catarina
Novartis Investigative Site Vancouver British Columbia
Novartis Investigative Site Changchun Jilin
Novartis Investigative Site Tianjin China
Novartis Investigative Site Prague Czechia
Novartis Investigative Site Toulouse France
Novartis Investigative Site Freiburg im Breisgau Baden-Wurttemberg
Novartis Investigative Site Alexandroupoli Greece
Novartis Investigative Site Pátrai Greece
Novartis Investigative Site Brescia BS
Novartis Investigative Site Florence FI
Novartis Investigative Site Genova GE
Novartis Investigative Site Milan MI
Novartis Investigative Site Roma RM
Novartis Investigative Site Fukushima Japan
Novartis Investigative Site Kuala Lumpur Malaysia
Novartis Investigative Site Badalona Barcelona
Novartis Investigative Site Barcelona Spain
Novartis Investigative Site Madrid Spain
Novartis Investigative Site Zurich Switzerland
Novartis Investigative Site Izmir Turkey (Türkiye)

On this site

📄 Venclexta (venetoclax) drug profile →

More Novartis Pharmaceuticals trials in Japan

Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease Active, not recruiting
An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care (SoC), Versus SoC Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Active, not recruiting
Fabhalta Capsules Specified Drug-use Survey Active, not recruiting
An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC. Recruiting
Study to Determine the Efficacy and Safety of Asciminib in Pediatric Patients With Ph+ CML-CP Recruiting

Other trials for the same condition

A Study of GLB-001 in Patients With Myeloid Malignancies Recruiting
A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With International Prognostic Scoring System Revised (IPSS-R) Low- or Intermediate-risk Myelodysplastic Syndrome (MDS) Active, not recruiting
Study of Efficacy and Safety of Eltrombopag in Lower-risk MDS Patients With Platelet Transfusion Dependence Active, not recruiting
A Study of TAK-226 for Anemia in Japanese Patients With Lower-Risk Myelodysplastic Syndromes Recruiting
A Rollover Study for Continued Study Treatment and Ongoing Safety Monitoring Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05201066 on ClinicalTrials.gov ↗ ← All trials in Japan