Double-Blind study comparing venetoclax and azacitidine versus placebo and azacitidine in patients that are newly diagnosed with Higher-Risk Myelodysplastic Syndrome

Phase 1

Active, not recruiting

• Conditions: Myelodysplastic Syndrome; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-000744-55-DE
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-16
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Adult male or female, at least 18 years old. Diagnosis of MDS according to the 2016 WHO classification with presence of < 20% bone marrow blasts per bone marrow biopsy/aspirate at screening. Subject meets the following disease activity criteria:
•Overall IPSS-R score > 3 (intermediate, high, or very high; Appendix E);
•Eastern Cooperative Oncology Group (ECOG) performance status = 2;
•HSCT eligible with no pre-arranged HSCT at the time of Study Day 1, or HSCT ineligible without plan for HSCT at the time of Study Day 1. No prior therapy for MDS with any hypomethylating agent (for example, azacitidine, decitabine), chemotherapy or allogeneic stem cell transplantation.

For further information on the inclusion criteria, please refer to section 5.1 Eligibility Criteria of the Study Protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

No previous diagnosis of:
•Therapy-related MDS (t-MDS)
•MDS evolving from a pre-existing myeloproliferative neoplasm (MPN)
•MDS/MPN including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), juvenile myelomonocytic leukemia (JMML) and unclassifiable MDS/MPN
• No prior therapy for MDS with any hypomethylating agent (for example, azacitidine, decitabine), chemotherapy or allogeneic stem cell transplantation. Lenalidomide, anti-thymocyte globulin (ATG), and cyclosporin are also excluded as these are considered disease-modifying agents.
• No known active SARS-CoV-2 infection. If a subject has signs/symptoms suggestive of SARS-CoV-2 infection, they should undergo molecular (e.g., PCR) testing to rule out SARS-CoV-2 infection.

For further information on the exclusion criteria, please refer to section 5.1 Eligibility Criteria of the Study Protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified