Venetoclax After TKI to Target Persisting Stem Cells in CML

Sponsor
Thomas Ernst, PD Dr. med.
Study ID
NCT05701215
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    Venetoclax will be taken orally once daily (400 mg) for 12 months

Study Details

There is currently no available treatment, capable to increase the rate of sustained deep molecular remissions after TKI discontinuation in CML. Venetoclax could be such a drug. The study will provide unprecedented biological insights on the effects of venetoclax in controlling minimal residual stem cell disease induced by long-term prior TKI therapy. If the study would be positive, the findings could become practice changing for patients in deep molecular remission under TKI and willing to tolerate a temporary additional treatment.

Key Dates

Start date
Aug 31, 2023
Status verified
Mar 2025
Primary completion
Jan 31, 2026
Completion
Jan 31, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Venetoclax
    Venetoclax will be taken orally once daily (400 mg) for 12 months after stop of TKI

Primary Outcome Measure

stem cell change [ Time Frame: at 6 months and 12 months after start of Venetoclax ]

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