CLL-Frail - A prospective, multicenter phase II trial of acalabrutinib in very old (≥80y) or frail CLL-Patients

Conditions

treatment-naïve or relapsed/refractory chronic lymphocytic leukemia

Brief summary

Overall response rate (ORR) at initial response assessment (cycle 7, day 1 = approx. 6 months after initiation of therapy).

Detailed description

ORR at final restaging (cycle 25, day 1 = approx. 24 months after initiation of therapy)., Overall survival (OS)., Progression free survival (PFS)., Event-free survival (EFS)., Duration of response., Time to next CLL treatment (TTNT)., Feasibility parameters: o Modification of treatment and reasons. o Treatment discontinuation: early discontinuation of treatment and reasons. o Treatment exposure: total cumulative dose, dose intensity, time on treatment (any dose), time on treatment (full dose), days with 0 dose., Safety parameters: Type, frequency, and severity of o adverse events (AEs) and o adverse events of special interest (AESI) and adverse events of particular interest (AEPI) including falls and delirium as typical adverse geriatric outcomes and their relationship to study treatment.

Related papers

No related papers found yet.

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGCalquence 100 mg film-coated tablets

DRUGCalquence 100 mg hard capsules

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall response rate (ORR) at initial response assessment (cycle 7, day 1 = approx. 6 months after initiation of therapy).	—

Secondary

Measure	Time frame
ORR at final restaging (cycle 25, day 1 = approx. 24 months after initiation of therapy)., Overall survival (OS)., Progression free survival (PFS)., Event-free survival (EFS)., Duration of response., Time to next CLL treatment (TTNT)., Feasibility parameters: o Modification of treatment and reasons. o Treatment discontinuation: early discontinuation of treatment and reasons. o Treatment exposure: total cumulative dose, dose intensity, time on treatment (any dose), time on treatment (full dose), days with 0 dose., Safety parameters: Type, frequency, and severity of o adverse events (AEs) and o adverse events of special interest (AESI) and adverse events of particular interest (AEPI) including falls and delirium as typical adverse geriatric outcomes and their relationship to study treatment.	—

Measure

Time frame

ORR at final restaging (cycle 25, day 1 = approx. 24 months after initiation of therapy)., Overall survival (OS)., Progression free survival (PFS)., Event-free survival (EFS)., Duration of response., Time to next CLL treatment (TTNT)., Feasibility parameters: o Modification of treatment and reasons. o Treatment discontinuation: early discontinuation of treatment and reasons. o Treatment exposure: total cumulative dose, dose intensity, time on treatment (any dose), time on treatment (full dose), days with 0 dose., Safety parameters: Type, frequency, and severity of o adverse events (AEs) and o adverse events of special interest (AESI) and adverse events of particular interest (AEPI) including falls and delirium as typical adverse geriatric outcomes and their relationship to study treatment.

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Countries

Austria, Germany

Outcome results

None listed