A Randomized, Double-Blind, Phase 3 Study Evaluating the Safety and Efficacy of Venetoclax in Combination with Azacitidine in Patients Newly Diagnosed with Higher-Risk Myelodysplastic Syndrome (Higher-Risk MDS)
- Conditions
- Myelodisplastic Syndrome (MDS)myelodysplasia10024324
- Registration Number
- NL-OMON54378
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 13
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.
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 of
SARS-CoV-2 infection, they should undergo molecular (e.g., PCR) testing to rule
out SARS-CoV-2 infection.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Overall Survival (OS)</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Complete remission (CR)<br /><br>- Overall hematological improvement (HI) (HI-platelet, HI-neutrophil, or<br /><br>HI-erythroid)<br /><br>- Red blood cell (RBC) and platelet transfusion independence for subjects who<br /><br>are transfusion dependent on RBC and/or platelet at baseline<br /><br>- Change from baseline in fatigue, as measured by the Patient-Reported Outcomes<br /><br>Measurement Information System (PROMIS)-Fatigue SF 7a<br /><br>- Time to deterioration in physical functioning, as measured by the physical<br /><br>functioning domain of EORTC QLQ-C30<br /><br>- Overall response (OR) defined as CR + partial response (PR)<br /><br>- Modified overall response (mOR) defined as CR + PR + marrow CR (mCR).</p><br>