Study of Efficacy and Safety of MBG453 in Combination With Azacitidine in Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)
- Conditions
- Myelodysplastic SyndromesLeukemia, Myelomonocytic, Chronic
- Registration Number
- NCT04266301
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 530
Inclusion Criteria:<br><br> - Signed informed consent must be obtained prior to participation in the study<br><br> - Age = 18 years at the date of signing the informed consent form<br><br> - Morphologically confirmed diagnosis of myelodysplastic syndrome (MDS) based on WHO<br> 2016 classification (Arber et al 2016) by local investigator assessment with one of<br> the following Prognostic Risk Categories, based on the revised International<br> Prognostic Scoring System (IPSS-R):<br><br> - Very high (> 6 points)<br><br> - High (> 4.5 - = 6 points)<br><br> - Intermediate (> 3 - = 4.5 points) Or Morphologically confirmed diagnosis of<br> Chronic Myelomonocytic Leukemia -2 based on WHO 2016 classification (Arber et<br> al 2016, including persistent monocytosis) by local investigator assessment<br> with WBC < 13 x 109/L at time of initial diagnosis<br><br> - Indication for azacitidine treatment according to the investigator, based on local<br> standard medical practice and institutional guidelines for treatment decisions<br><br> - Not eligible at time of screening for intensive chemotherapy according to the<br> investigator, based on local standard medical practice and institutional guidelines<br> for treatment decisions, including assessment of individual clinical factors such as<br> age, comorbidities and performance status<br><br> - Not eligible at time of screening for hematopoietic stem cell transplantation (HSCT)<br> according to the investigator, based on local standard medical practice and<br> institutional guidelines for treatment decisions, including assessment of individual<br> clinical factors such as age, comorbidities, performance status, and donor<br> availability<br><br> - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2<br><br>Exclusion Criteria:<br><br> - Prior exposure to TIM-3 directed therapy at any time. Prior therapy with immune<br> checkpoint inhibitors (e.g, anti-CTLA4, anti-PD-1, anti-PD-L1, or anti-PD-L2),<br> cancer vaccines is allowed except if the drug was administered within 4 months prior<br> to randomization<br><br> - Previous first-line treatment for intermediate, high, very high risk myelodysplastic<br> syndromes (based on IPSS-R) or CMML with any antineoplastic agents including for<br> example chemotherapy, lenalidomide and hypomethylating agents (HMAs) such as<br> decitibine and azacitidine. However, previous treatment with hydroxyurea or<br> leukopheresis to reduce WBC count is allowed prior to randomization.<br><br> - Investigational treatment received within 4 weeks or 5 half-lives of this<br> investigational treatment, whatever is longer, prior to randomization. In case of a<br> checkpoint inhibitor: a minimal interval of 4 months prior to randomization is<br> necessary to allow randomization.<br><br> - Subjects with Myelodysplastic syndrome (MDS) based on 2016 WHO classification (Arber<br> et al 2016) with revised International Prognostic Scoring System (IPSS-R) = 3<br><br> - Diagnosis of acute myeloid leukemia (AML) including acute promyelocytic leukemia and<br> extra-medullary acute myeloid leukemia, primary or secondary myelofibrosis based on<br> WHO 2016 classification (Arber et al 2016)<br><br> - Diagnosis of therapy related myeloid neoplasms based on WHO 2016 classification<br> (Arber et al 2016)<br><br> - History of organ or allogeneic hematopoietic stem cell transplant<br><br>Other protocol-defined Inclusion/Exclusion Criteria may apply.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival
- Secondary Outcome Measures
Name Time Method