Clinical trial · Interventional
Phase 2 Dasatinib Combo With Smoothened (SMO) Antagonist (BMS-833923)
An Open-Label, Randomized, Multicenter Phase 2 Trial of Dasatinib (SPRYCEL®) vs. Dasatinib Plus Smoothened Antagonist (BMS-833923) in the Treatment of Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia (CML).
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No participants enrolled in this trial could receive the SMO antagonist as a recommended phase 2 dose was not determined by a different, concurrently-run trial.
Summary
Brief summary (as posted)
The purpose of the study is to compare response rates in newly diagnosed Chronic Phase (CP) CML subjects treated with dasatinib plus BMS-833923 versus dasatinib alone.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-833923 | Drug | — | UNRESOLVED |
| Dasatinib | Drug | Dasatinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm 1: Dasatinib
- interventionNames
- Drug: Dasatinib
- type
- EXPERIMENTAL
- label
- Arm2: Dasatinib + BMS-833923
- description
- Dasatinib for 1 year followed by dasatinib plus BMS-833923 for 2 years followed by dasatinib alone for approximately 2 years; depending on response
- interventionNames
- Drug: Dasatinib
- Drug: BMS-833923
Primary outcomes (1)
- measure
- Number of Participants With Major Molecular Response
- timeFrame
- Baseline up to 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects ≥ 18 years of age who have signed informed consent * Philadelphia positive Chronic Myeloid Leukemia (CML) in chronic phase * Previously untreated chronic phase CML, except for Anagrelide or Hydroxyurea. * Eastern Co-Operative Group (ECOG) Performance Status (PS) Score 0 - 2 Exclusion Criteria: * Known Abl-kinase T315I or T315A mutation * Serious or uncontrolled medical disorder (including infection or cardiovascular disease) or dementia or other serious psychiatric condition * Prior chemotherapy. * Women who are pregnant or breastfeeding or Women of Child Bearing Potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy during the entire study period.
References
Publications (0)
Data not yet available