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ACTIW: Candidate Therapies with TKIs in CML Patients
NCT02767063Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Jul 2016
- Primary completion
- Dec 2027
- Countries
- 1
- Sponsor
- Centre Hospitalier de Versailles
- Modality
- Immune Checkpoint Inhibitors, Recombinant Proteins and Enzymes, Small Molecules
- Drugs
- pioglitazoneavelumab
- Conditions
- Chronic Myeloid Leukemia (CML)
01
Overview
Phase 2, randomised, open-label trial of pioglitazone and avelumab in Chronic Myeloid Leukemia (CML) (3 arms), sponsored by Centre Hospitalier de Versailles. Primary endpoint: Cumulative incidence of patients achieving a deep molecular response at 12 months. Started Jul 2016; status: active, not recruiting.
02
Design
3 arms- Study design
- RandomizedOpen-label
Experimental Arm_ACTOS
TKI + Pioglitazone
controled Arm
TKI alone
Experimental Arm_AVELUMAB
TKI + Avelumab
03
Who it enrols
Adult patients with Philadelphia chromosome positive chronic phase CML, treated with a TKI for >2 years, who have achieved complete cytogenetic response but not a deep molecular response (detectable BCR-ABL1 > 0.0032%).
04
Endpoints
Primary
Cumulative incidence of patients achieving a deep molecular response
Secondary
Adverse events
The cumulative rate of patients achieving MR4.5
The cumulative rate of patients achieving MR4
The cumulative rate of patients with undetectable BCR-ABL1 transcript
The rate of patients in treatment free remission during follow-up
Quantification of CML- and normal-CFU in bone marrow by clonogenic assays and RTQ-PCR
Survival
Duration of response
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