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Clinical Trials List

Protocol NumberM15-954

NCT Number(ClinicalTrials.gov Identfier)NCT04401748

Active

2020-07-24 - 2027-01-31

Phase III

Recruiting1

Terminated2

ICD-10D46.9

Myelodysplastic syndrome, unspecified

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)

Trial Applicant

AbbVie
Sponsor

AbbVie
Trial scale

Multi-Regional Multi-Center
Update

2026/02/01

Investigators and Locations

Principal Investigator Su-Peng Yeh 無

China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 馮盈勳無

Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Tsai-Yun Chen 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Condition/Disease

Myelodysplastic Syndrome (MDS)

Objectives

The purpose of this study is to see how safe and effective venetoclax and azacitidine (AZA) combination are when compared to AZA and a placebo (contains no medicine), in participants with newly diagnosed higher-risk MDS.

Test Drug

Venetoclax

Active Ingredient

Venetoclax

Dosage Form

Tablet

Dosage

10mg/tab
50mg/tab
100mg/tab

Endpoints

Primary Outcome Measures:
1.Complete Remission (CR)
2.Overall survival (OS)

Secondary Outcome Measures:
1.Percentage of Participants Achieving Transfusion Independence (TI) Who are Transfusion Dependent at Baseline
2.Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue Short Form (SF) 7a Scale Score
3.Time to Deterioration in Physical Functioning as Measured by Physical Functioning Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scale
4.Overall Response (OR)
5.Modified Overall Response (mOR)

Inclution Criteria

1.Participants with a diagnosis of Myelodysplastic Syndrome (MDS) according to the 2016 World Health Organization (WHO) classification wtih presence of < 20% bone marrow blasts per marrow biopsy/aspirate at screening.
2.Participants must meet the following disease activity criteria:
- Overall Revised International Prognostic Scoring System (IPSS-R) score > 3 (intermediate, high or very high).
- Eastern Cooperative Oncology Group (ECOG) performance status of <= 2.
- Hematopoietic stem cell transplant (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.

Exclusion Criteria

1.Prior therapy for MDS with any hypomethylating agent, chemotherapy, or allogenic stem cell transplantation.
2.Prior 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.

The Estimated Number of Participants

Taiwan

15 participants
Global

500 participants