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Second STOP After Pioglitazone Priming in CML Patients

NCT02889003 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2018-03-22

No results posted yet for this study

Summary

Single-center study, prospective, phase II trial.

The study objectives are :

* To assess safety and pharmacokinetics of the combination of PIO and TKI in CML subjects who experience a loss of MMR following a first TKI discontinuation.
* To assess survival without loss of MMR over a 12 months period following a second TKI discontinuation in subjects who achieve or maintain \< MR4.5 with the combination PIO and TKI administered for at least 6 months.

Conditions

  • Chronic Myeloid Leukemia (CML)

Interventions

DRUG

Pioglitazone + TKI

Sponsors & Collaborators

  • Pr Philippe ROUSSELOT

    collaborator UNKNOWN

  • Versailles Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02889003 on ClinicalTrials.gov