Sequential Regimen of Bendamustine-Debulking Followed by CAL-101 and GA101-Induction and -Maintenance in CLL (CLL2-BCG)
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|ClinicalTrials.gov Identifier: NCT02445131|
Recruitment Status : Recruiting
First Posted : May 15, 2015
Last Update Posted : June 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leucemia||Drug: Bendamustine Drug: GA101 Drug: CAL-101||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||62 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective, Open-label, Multicenter Phase-II Trial to Evaluate Efficacy and Safety of a Sequential Regimen of Bendamustine Followed by GA101 (Obinutuzumab) and CAL-101 (Idelalisib) Followed by CAL-101 and GA101 Maintenance in CLL Patients|
|Actual Study Start Date :||May 27, 2015|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||May 2020|
Experimental: Bendamustine + GA101 + CAL-101
Bendamustine: 70 mg/m2 i.v. GA101: 1000 mg CAL-101: 150 mg p.o.
Debulking: Cycles 1 - 2, d1 & 2: 70 mg/m2 i.v.
Induction: Cycle 1: d1: 100mg, d1(or2): 900mg, d8 & 15: 1000mg; Cycle 2-6: d1: 1000mg
Maintenance: Cycle 1-8 (Duration 12 weeks): d1 1000 mg.
Other Name: Obinutuzumab
Induction: Cycle 2-6: d1-28: 150 mg p.o.
Maintenance: Cycles 1-8 (Duration 12 weeks): d1-84 150 mg p.o.
Other Name: Idelalisib
- Overall response rate (ORR) [ Time Frame: 84 days after start of the last induction cycle ]Proportion of patients responding according to international working Group on chronic lymphocytic leukemia criteria
- Adverse Events (AEs) and adverse events of special interest (AESI) [ Time Frame: up to 40 months after first dose of study drug ]Type, frequency and severity of adverse events (AEs) and adverse events of special interest (AESI) and their relationship to study treatment
- Rate of minimal residual disease (MRD) [ Time Frame: up to 40 months ]Rate of MRD responses in peripheral blood measured by immunophenotyping
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02445131
|Contact: Paula Cramer, Dr. med.||0221 478 email@example.com|
|Contact: Julia von Tresckow, Dr. med.||0221 478 firstname.lastname@example.org|
|German CLL Study Group||Recruiting|
|Cologne, Germany, 50935|
|Contact: Paula Cramer, Dr. med. 0221 478 88220 email@example.com|
|Contact: Julia von Tresckow, Dr. med. 0221 478 88220 firstname.lastname@example.org|
|Principal Investigator:||Paula Cramer, Dr. med.||German CLL Study Group|