Status:
TERMINATED
A Study of Sabatolimab in Combination With Azacitidine and Venetoclax in High or Very High Risk MDS Participants
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Myelodysplastic Syndrome (MDS)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of the study was to find out if the new drug sabatolimab when given in combination with azacitidine and venetoclax, was safe and had beneficial effects in participants with high or very hi...
Detailed Description
Approximately 76 people with high or very high risk myelodysplastic syndrome (MDS) and age ≥ 18 years were to be asked to join this study but due to the decision by Novartis to halt recruitment the st...
Eligibility Criteria
Inclusion
- Signed informed consent must be obtained prior to participation in the study
- Age ≥ 18 years at the date of signing the informed consent form (ICF)
- Morphologically confirmed diagnosis of myelodysplastic syndrome (MDS) based on 2016 WHO classification (Arber et al, 2016) by local investigator assessment with one of the following Prognostic Risk Categories, based on the revised International Prognostic Scoring System (IPSS-R) (Greenberg et al 2012):
- Very high (\> 6 points)
- High (\> 4.5-6 points)
- Not immediately eligible for hematopoietic stem-cell transplantation (HSCT) or intensive chemotherapy at the time of screening due to individual clinical factors such as age, comorbidities and performance status, donor availability (de Witte et al 2017)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Exclusion
- Prior exposure to TIM-3 directed therapy or any BCL-2 inhibitor (including venetoclax) at any time
- Prior therapy with immune check point inhibitors (e.g. anti-CTLA4, anti-PD-1, anti-PD-L1, or anti-PD-L2) or cancer vaccines is not allowed if the last dose of the drug was administered within 4 months prior to start of treatment
- Previous first-line treatment for very high risk or high risk myelodysplastic syndromes (based on IPSS-R,Greenberg et al 2012 and Arber et al, 2016) with any antineoplastic agents, approved or investigational, including for example chemotherapy, lenalidomide and hypomethylating agents (HMAs) such as decitabine or azacitidine However, a one single cycle of HMAs treatment only started prior to enrollment is allowed.
- Live vaccine administered within 30 days prior to start of treatment
- Current use or use within 14 days prior to start of treatment of systemic steroid therapy (\> 10 mg/day prednisone or equivalent) or any immunosuppressive therapy. Topical, inhaled, nasal, ophthalmic steroids are allowed. Replacement therapy, steroids given in the context of a transfusion, are allowed and not considered a form of systemic treatment
- History of severe hypersensitivity reactions to any ingredient of study drug(s) (azacitidine, venetoclax or sabatolimab) or monoclonal antibodies (mAbs) and/or their excipients
- Participants with Myelodysplastic syndrome (MDS) based on 2016 WHO classification (Arber et al, 2016) with revised International Prognostic Scoring System (IPSS-R) ≤ 4.5
Key Trial Info
Start Date :
May 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 8 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04812548
Start Date
May 31 2021
End Date
May 8 2023
Last Update
October 9 2025
Active Locations (10)
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1
Novartis Investigative Site
Brasschaat, Belgium, 2930
2
Novartis Investigative Site
Marseille, France, 13273
3
Novartis Investigative Site
Nice, France, 06202
4
Novartis Investigative Site
Düsseldorf, Germany, 40479