STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS | Aplastic Anemia & MDS International Foundation Return to top.

ClinicalTrials.gov Identifier:

NCT04878432

Contact Info

1-844-764-6682 or 1-844-PNH-NOVA

Dates

Start: March 2022
End: March 2025

Official Title

STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS

Purpose

This is a single-arm, nonrandomized, open-label, Phase II multicenter study of intravenous MBG453 (sabatolimab) added to hypomethylating agents (HMA) of investigator's choice (IV/SC/ Oral) in adult participants with intermediate, high or very high risk myelodysplastic syndrome (MDS) as per IPSS-R criteria. The study will assess the safety and efficacy of sabatolimab (investigational drug) in combination with an HMA. The study will enroll approximately 90 participants in the United States.

MBG453/sabatolimab is an investigational compound. Efficacy and safety have not been established. There is no guarantee that sabatolimab will become commercially available.

STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS

Clinical Trial: NCT04878432

Instructions

If you are interested in learning more about your possible participation in this clinical trial, please complete the form. Your information will be forwarded directly to the sponsoring company.

Status: 
Recruiting
Associated Drug(s): 
Phase: 
Phase 2
Gender: 
Female
Male
Age Group: 
18 years and older
Accepts Healthy Volunteers: 
No
Inclusion Criteria: 
  • Aged ≥18 years with a morphologically confirmed diagnosis of MDS based on WHO 2016 classification
  • MDS prognostic risk based on the IPSS-R: very high (>6 points), high (>4.5-6 points), or intermediate (>3-4.5 points)
  • Not suitable at the time of screening for immediate myeloablative chemotherapy or hematopoietic stem cell transplantation
  • ECOG performance status of 0-2
  • AST and ALT ≤ 3 × upper limit of normal (ULN)
  • Total bilirubin ≤ 2 × ULN (except in the setting of isolated Gilbert syndrome)
  • Estimated Glomerular Filtration Rate (eGFR) ≥ 30 mL/min/1.73m2 (estimation based on Modification of Diet in Renal Disease (MDRD) formula, by local laboratory)
Exclusion Criteria: 
  • Prior exposure to TIM-3 directed therapy at any time. Prior therapy with immune checkpoint inhibitors (eg, anti-CTLA4, anti-PD-1, anti-PD-L1, or anti-PD-L2), cancer vaccines are allowed only if the last dose of the drug was administered more than 4 months prior to enrollment
  • Previous treatment for intermediate, high or very high risk myelodysplastic syndromes (based on IPSS-R) with chemotherapy or other antineoplastic agents including lenalidomide and hypomethylating agent (HMAs) such as decitabine or azacitidine or INQOVI (oral decitabine) (patients who had up to 1 cycle of HMAs can be included). However, previous treatment with hydroxyurea is permitted
  • Diagnosis of acute myeloid leukemia (AML) including acute promyelocytic leukemia and extra-medullary acute myeloid leukemia based on WHO 2016 classification (Arber, et al 2016)
  • Diagnosis of chronic myelomonocytic leukemia (CMML), or primary or secondary myelofibrosis based on 2016 WHO classification (Arber, et al 2016)
  • History of organ transplant or allogeneic hematopoietic stem cell transplant
  • Participants with prior malignancy, except:
    • Participants with history of lower risk MDS treated by supportive care (eg, growth factors, TGF-beta agents) or untreated are eligible
    • Participants with history of lower risk MDS who were treated adequately with lenalidomide and then failed are eligible
    • Participants with history of adequately treated malignancy for which no anticancer systemic therapy (namely chemotherapy, radiotherapy or surgery) is ongoing or required during the course of the study. Participants who are receiving adjuvant therapy such as hormone therapy are eligible
  • Participants with myelodysplastic syndrome (MDS) based on 2016 WHO classification (Arber, et al 2016) with revised International Prognostic Scoring System (IPSS-R) ≤ 3

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Disclaimer:

AAMDSIF does not recommend, endorse, or make any representation about the efficacy, appropriateness or suitability of any clinical trial listed on this website. Pharmaceutical company sponsored content is highlighted only to give additional information about the trial. All trials are listed on https://clinicaltrials.gov/. Always seek the advice of your physician or other qualified health care provider with any questions you may have regarding a clinical trial, and never disregard professional medical advice or delay in seeking it because of something you have read on this website.

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