Clinical trial · Interventional
Study of Ipilimumab and Dasatinib Combination Therapy in Patients With Chronic or Accelerated Chronic Myeloid Leukemia
Phase Ib Study Evaluating the Safety and Exploring the Molecular and Cytogenetic Response of Combination Therapy With Dasatinib and Ipilimumab in Patients With Chronic or Accelerated Phase Chronic Myeloid Leukemia
NCT00732186CI-TRIAL-00020935withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to assess the safety of ipilimumab and dasatinib combination therapy in patients with CML
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, Myeloid, Chronic | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ipilimumab | Biological | Ipilimumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Group 1 and Group 2
- interventionNames
- Biological: Ipilimumab
Primary outcomes (1)
- measure
- To evaluate the safety of ipilimumab in combination with dasatinib in CML patients with a loss of previously achieved major molecular response or a loss of previously achieved cytogenetic response to dasatinib
- timeFrame
- At weeks 1, 4, 7, 10, 14, 18, 22, 26, 30, 34 and 38
Secondary outcomes (3)
- measure
- To evaluate the frequency of molecular response, complete cytogenetic response and an overall efficacy signal response rate
- timeFrame
- At weeks 1, 4, 7, 10, 14, 18, 22, 26, 30, 34 and 38
- measure
- To explore the immunologic responses to combination therapy with ipilimumab and dasatinib
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Ph+ CML on dasatinib therapy * Loss of cytogenetic or molecular response while on dasatinib therapy * On stable dose of dasatinib for a minimum of 12 weeks and with \< 14 day interruption of treatment Exclusion Criteria: * Blast crisis CML * Autoimmune disease * Uncontrolled or significant cardiovascular disease
References
Publications (0)
Data not yet available
No reference posted for this study.