AITIK-Discontinuation of TyrosIne Kinase Inhibitors (ITK) in Chronic Myeloid Leukemia (LMC) and Impact on the Immune System: a Randomized Comparative Study of Two Therapeutic Strategies

Conditions

Chronic Myeloid Leukemia

Brief summary

Proportion (%) of patients in TFR 24 months after discontinuation in the dose maintenance then discontinuation arm and in the dose deescalation then discontinuation arm.

Detailed description

1-Recording of adverse events and scoring according to CTCAE V5 grades, 2.8-Collection of EQ-5D5 and FACT-Leu32, 3-Proportion (%) of patients losing their MMR, 4.7-Proportion (%) of patients losing their DMR, 5-Quantitative analysis: difference in the proportions, at randomisation and 12 months post-randomisation, of innate CD8 LTs within total CD8 LTs, 6-Evaluation of the residual plasma concentration of the TKI in ng/mL, 9-After loss of DMR during the treatment phase: collection of the prescribed TKI and its daily dosage (mg per day) as well as the time (in months) between the loss of DMR and its re-obtainment; after loss of MMR during the discontinuation phase: collection of the time (in months) between the loss of MMR and its re-obtainment, 10- Quantitative analysis: proportions of CD8i LTs in total CD8 LTs, 11- Quantitative analysis: proportions of innate CD8 LTs in total CD8 LTs

Related papers

No related papers found yet.

Interventions

DRUGSPRYCEL 50 mg film-coated tablets

DRUGTasigna 200 mg hard capsules

DRUGTasigna 150 mg hard capsules

DRUGGlivec 100 mg film-coated tablets

DRUGSPRYCEL 20 mg film-coated tablets

DRUGBosulif 100 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion (%) of patients in TFR 24 months after discontinuation in the dose maintenance then discontinuation arm and in the dose deescalation then discontinuation arm.	—

Secondary

Measure	Time frame
1-Recording of adverse events and scoring according to CTCAE V5 grades, 2.8-Collection of EQ-5D5 and FACT-Leu32, 3-Proportion (%) of patients losing their MMR, 4.7-Proportion (%) of patients losing their DMR, 5-Quantitative analysis: difference in the proportions, at randomisation and 12 months post-randomisation, of innate CD8 LTs within total CD8 LTs, 6-Evaluation of the residual plasma concentration of the TKI in ng/mL, 9-After loss of DMR during the treatment phase: collection of the prescribed TKI and its daily dosage (mg per day) as well as the time (in months) between the loss of DMR and its re-obtainment; after loss of MMR during the discontinuation phase: collection of the time (in months) between the loss of MMR and its re-obtainment, 10- Quantitative analysis: proportions of CD8i LTs in total CD8 LTs, 11- Quantitative analysis: proportions of innate CD8 LTs in total CD8 LTs	—

Measure

Time frame

1-Recording of adverse events and scoring according to CTCAE V5 grades, 2.8-Collection of EQ-5D5 and FACT-Leu32, 3-Proportion (%) of patients losing their MMR, 4.7-Proportion (%) of patients losing their DMR, 5-Quantitative analysis: difference in the proportions, at randomisation and 12 months post-randomisation, of innate CD8 LTs within total CD8 LTs, 6-Evaluation of the residual plasma concentration of the TKI in ng/mL, 9-After loss of DMR during the treatment phase: collection of the prescribed TKI and its daily dosage (mg per day) as well as the time (in months) between the loss of DMR and its re-obtainment; after loss of MMR during the discontinuation phase: collection of the time (in months) between the loss of MMR and its re-obtainment, 10- Quantitative analysis: proportions of CD8i LTs in total CD8 LTs, 11- Quantitative analysis: proportions of innate CD8 LTs in total CD8 LTs

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Countries

France

Outcome results

None listed