A Study Evaluating Venetoclax in Combination with Azacitidine Compared with Azacitidine Alone in Subjects with Previously Untreated Higher-Risk Myelodysplastic Syndromes (MDS)

Phase 1

• Conditions: Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS); MedDRA version: 20.0Level: PTClassification code 10028533Term: Myelodysplastic syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-001657-41-GB
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-13
• Last Update Posted: 29 May 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Subject must be = 18 years of age.
2. Subject must have documented diagnosis of 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 < 30% bone marrow blasts per bone marrow
biopsy/aspirate at screening
3. Subject must have an Eastern Cooperative Oncology Group (ECOG) performance score of = 2.
4. Subject must have received no prior therapy for MDS.
NOTE: Patients who only received supportive care for MDS (e.g., transfusions, growth factors) are eligible to enrol in the study.
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 70

Exclusion Criteria

1. Subject has therapy-related MDS (t-MDS).
2. Subject has MDS evolving from a pre-existing myeloproliferative neoplasm (MPN).
3. Subject has MDS/MPN including chronic myelomonocytic leukemia (CMML), atypical chronic myelogenous leukemia (CML), juvenile myelomonocytic leukemia (JMML) and unclassifiable MDS/MPN.
4. Subject has received prior therapy with a BH3 mimetic.
5. Subject has received allogeneic HSCT or solid organ transplantation .

Study & Design

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