The trial is taking place at:
D

Dana-Farber Cancer Institute | Pediatric Hematologic Malignancy

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A Study Evaluating Venetoclax in Combination With Azacitidine in Participants With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)

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AbbVie

Status and phase

Active, not recruiting
Phase 1

Conditions

Myelodysplastic Syndromes (MDS)

Treatments

Drug: Venetoclax
Drug: Azacitidine

Study type

Interventional

Funder types

Industry

Identifiers

NCT02942290
2016-001657-41 (EudraCT Number)
M15-531

Details and patient eligibility

About

This is a Phase 1b, open-label, non-randomized, multicenter, dose-finding study evaluating venetoclax in combination with azacitidine in participants with treatment-naïve higher-risk MDS comprising a dose-escalation portion and a safety expansion portion.

Enrollment

129 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

* Participant must have documented diagnosis of untreated de novo MDS with: * International Prognostic Scoring System (IPSS) risk categories Int-2 or High (minimum IPSS overall score of 1.5) OR Revised IPSS (IPSS-R) categories intermediate, high or very high (score of \> 3) and * Presence of less than 20% bone marrow blasts per bone marrow biopsy/aspirate. * Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2.

Exclusion criteria

* Participant has received prior therapy for MDS. (Prior supportive care in form of transfusions or growth factors, etc., is not considered prior therapy). * Participant has received prior therapy with a BCL-2 Homology 3 (BH3) mimetic. * Participant has a diagnosis other than previously untreated de novo MDS (as defined in the protocol) including: * MDS with IPSS risk categories Low or Int-1 (overall IPSS score \< 1.5) * 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 (CML), juvenile myelomonocytic leukemia (JMML) and unclassifiable MDS/MPN. * Participant has received allogeneic Hematopoietic Stem Cell Transplantation (HSCT) or solid organ transplantation. * Participant has received a live attenuated vaccine within 4 weeks prior to the first dose of study drug.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

129 participants in 1 patient group

Venetoclax + Azacitidine
Experimental group
Treatment:
Drug: Azacitidine
Drug: Venetoclax

Trial contacts and locations

37

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Data sourced from clinicaltrials.gov

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