A Study Evaluating Venetoclax with Azacitidine in Subjects with PreviouslyUntreated Higher-Risk Myelodysplastic Syndromes (MDS)

Phase 1

• Conditions: Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS); Therapeutic area: Diseases [C] - Cancer [C04]; MedDRA version: 20.0Level: LLTClassification code 10028532Term: MyelodysplasiaSystem Organ Class: 100000004864

• Registration Number: EUCTR2016-001657-41-IT
• Lead Sponsor: ABBVIE DEUTSCHLAND GMBH & CO. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-21
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Subject must voluntarily sign and date an informed consent, approved
by an Independent Ethics Committee (IEC)/Institutional Review Board
(IRB), prior to the initiation of any screening or study specific
procedures.
2. Subject must be = 18 years of age.
3. Subject must have documented diagnosis of previously untreated de
novo MDS with:
¿ International Prognostic Scoring System (IPSS) risk categories Int-2
or High (IPSS overall score = 1.5) and
¿ Presence of = 5% and < 20% bone marrow blasts per bone marrow
biopsy/aspirate at screening
4. Subject must have an Eastern Cooperative Oncology Group (ECOG)
performance score of = 2.
5. Subject is not a candidate to undergo intensive chemotherapy or
allogeneic hematopoietic stem cell transplantation (HSCT).
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1. Subject has received prior therapy for MDS.
2. Subject has received prior therapy with a BH3 mimetic.
3. Subject has received allogeneic HSCT or solid organ transplantation .
4. Subject has received a live attenuated vaccine within 4 weeks prior to
the first dose of study drug.

Study & Design

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