FILOCLL14 - STAIR : "Open-label, phase 2 study investigating the STop and restart Acalabrutinib In fRrail patients with previously untreated CLL (STAIR)"

Conditions

elderly patients (> 70 years) with CLL or SLL

Brief summary

PFS at 1 year post-ACA discontinuation is defined as the time from randomization to progression (needing therapy or not) or death from any cause. Patients alive and progression-free will be censored at the last disease assessment or at initiation of next treatment. Progression will be evaluated using iwCLL 2018 criteria

Detailed description

OS is defined as the time from randomization to death from any cause. Patients alive will be censored at last follow-up news., TTNT is defined as the time from randomization to initiation of next treatment required for symptomatic CLL. Patients without initiation of next treatment will be censored at last follow-up date. This need for restarting therapy will be centrally validated by an independent board review and based on iwCLL 2018 criteria for symptomatic CLL., QoL will be evaluated using the EORTC QLQ-C30 questionnaire, Secondary end point (English), Overall Response Rate (ORR) to re-treatment is defined as the proportion of re-treated patients who achieved best response of complete remission (CR), complete remission with incomplete marrow recovery (CRi), nodular partial remission (nPR), or partial remission (PR) per iwCLL 2018 criteria.

Related papers

No related papers found yet.

Interventions

DRUGCalquence 100 mg film-coated tablets

DRUGCalquence 100 mg hard capsules

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Design outcomes

Primary

Measure	Time frame
PFS at 1 year post-ACA discontinuation is defined as the time from randomization to progression (needing therapy or not) or death from any cause. Patients alive and progression-free will be censored at the last disease assessment or at initiation of next treatment. Progression will be evaluated using iwCLL 2018 criteria	—

Secondary

Measure	Time frame
OS is defined as the time from randomization to death from any cause. Patients alive will be censored at last follow-up news., TTNT is defined as the time from randomization to initiation of next treatment required for symptomatic CLL. Patients without initiation of next treatment will be censored at last follow-up date. This need for restarting therapy will be centrally validated by an independent board review and based on iwCLL 2018 criteria for symptomatic CLL., QoL will be evaluated using the EORTC QLQ-C30 questionnaire, Secondary end point (English), Overall Response Rate (ORR) to re-treatment is defined as the proportion of re-treated patients who achieved best response of complete remission (CR), complete remission with incomplete marrow recovery (CRi), nodular partial remission (nPR), or partial remission (PR) per iwCLL 2018 criteria.	—

Measure

Time frame

OS is defined as the time from randomization to death from any cause. Patients alive will be censored at last follow-up news., TTNT is defined as the time from randomization to initiation of next treatment required for symptomatic CLL. Patients without initiation of next treatment will be censored at last follow-up date. This need for restarting therapy will be centrally validated by an independent board review and based on iwCLL 2018 criteria for symptomatic CLL., QoL will be evaluated using the EORTC QLQ-C30 questionnaire, Secondary end point (English), Overall Response Rate (ORR) to re-treatment is defined as the proportion of re-treated patients who achieved best response of complete remission (CR), complete remission with incomplete marrow recovery (CRi), nodular partial remission (nPR), or partial remission (PR) per iwCLL 2018 criteria.

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Countries

France

Outcome results

None listed