A phase 3 multicentre, randomized, prospective, open-label trial of Ibrutinib monotherapy versus fixed-duration Venetoclax plus Obinutuzumab versus fixed-duration Venetoclax plus Ibrutinib in patients with previously untreated chronic lymphocytic leukaemia (CLL) - CLL17

Conditions

treatment-naive chronic lymphocytic leukemia

Brief summary

Progression-free survival (PFS)

Detailed description

Rates of undetectable MRD (uMRD, i.e. <10E-4) in peripheral blood (PB) and bone marrow (BM) at final restaging (RE), which will be at cycle 18 after start of treatment, and additional BM assessment approx. 12 months after RE, MRD levels in PB at different time points (cycle 1 before start of ther-apy, start of cycle 7, start of cycle 13 [end of VG treatment], start of cycle 16 [end of VI treatment], final restaging [cycle 18], afterwards every 6 months to end of study), Duration of undetectable MRD (uMRD), Overall response rate (ORR; defined as rate of a response of CR, CRi, or PR) as per iwCLL guidelines at final restaging, Duration of response, Complete response rate (CRR; defined as rate of a response of CR or CRi) at final restaging as per iwCLL guidelines, Overall survival (OS), Event-free survival (EFS) (I vs VG and I vs VI), Time to next treatment (TTNT), PFS2 (i.e. PFS after second-line treatment)

Related papers

No related papers found yet.

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

Interventions

DRUGIMBRUVICA 140 mg hard capsules

DRUGGazyvaro 1

DRUG000 mg concentrate for solution for infusion.

DRUGVenetoclax

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS)	—

Secondary

Measure	Time frame
Rates of undetectable MRD (uMRD, i.e. <10E-4) in peripheral blood (PB) and bone marrow (BM) at final restaging (RE), which will be at cycle 18 after start of treatment, and additional BM assessment approx. 12 months after RE, MRD levels in PB at different time points (cycle 1 before start of ther-apy, start of cycle 7, start of cycle 13 [end of VG treatment], start of cycle 16 [end of VI treatment], final restaging [cycle 18], afterwards every 6 months to end of study), Duration of undetectable MRD (uMRD), Overall response rate (ORR; defined as rate of a response of CR, CRi, or PR) as per iwCLL guidelines at final restaging, Duration of response, Complete response rate (CRR; defined as rate of a response of CR or CRi) at final restaging as per iwCLL guidelines, Overall survival (OS), Event-free survival (EFS) (I vs VG and I vs VI), Time to next treatment (TTNT), PFS2 (i.e. PFS after second-line treatment)	—

Measure

Time frame

Rates of undetectable MRD (uMRD, i.e. <10E-4) in peripheral blood (PB) and bone marrow (BM) at final restaging (RE), which will be at cycle 18 after start of treatment, and additional BM assessment approx. 12 months after RE, MRD levels in PB at different time points (cycle 1 before start of ther-apy, start of cycle 7, start of cycle 13 [end of VG treatment], start of cycle 16 [end of VI treatment], final restaging [cycle 18], afterwards every 6 months to end of study), Duration of undetectable MRD (uMRD), Overall response rate (ORR; defined as rate of a response of CR, CRi, or PR) as per iwCLL guidelines at final restaging, Duration of response, Complete response rate (CRR; defined as rate of a response of CR or CRi) at final restaging as per iwCLL guidelines, Overall survival (OS), Event-free survival (EFS) (I vs VG and I vs VI), Time to next treatment (TTNT), PFS2 (i.e. PFS after second-line treatment)

—

Countries

Austria, Belgium, Denmark, Finland, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden

Outcome results

None listed