Sequential Regimen of Bendamustin-Debulking Followed by Obinutuzumab, Acalabrutinib and Venetoclax in Patients With Relapsed/Refractory CLL (CLL2-BAAG)
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|ClinicalTrials.gov Identifier: NCT03787264|
Recruitment Status : Recruiting
First Posted : December 26, 2018
Last Update Posted : February 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphoid Leukemia||Drug: Bendamustine Biological: Obinutuzumab Biological: Acalabrutinib Biological: Venetoclax||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Open-label, Multicenter Phase-II Trial to Evaluate the Efficacy and Safety of a Sequential Regimen of Bendamustine Followed by GA101 (Obinutuzumab), Acalabrutinib (ACP-196) and ABT-199 (Venetoclax) in Patients With Relapsed/Refractory CLL (CLL2-BAAG Protocol)|
|Actual Study Start Date :||January 14, 2019|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||September 2023|
Debulking: 2 debulking cycles (q 28d) of bendamustine will be administered unless the patient has a contraindication or a debulking is not clinically indicated
Induction: 6 cycles (q 28d) of Obinutuzumab + Acalabrutinib + Venetoclax
Maintenance: max. 8 cycles (q 84d) of Obinutuzumab + Acalabrutinib + Venetoclax
Maintenance treatment will be continued until (whichever occurs first):
Debulking: Cycles 1-2: d1+2 - 70mg/m² i.v.
Induction: Cycle 1: d1 - 100 mg, d1 (or d2) - 900 mg, d8 + d15 - 1000 mg i.v.; Cycle 2 - 6: 1000 mg, d1 i.v.
Maintenance: Cycle 1 - 8: 1000 mg, d1 i.v.
Induction: Cycle 1: --; Cycles 2 - 6: d1-28: 2 x 100mg p.o.
Maintenance: Cycle 1 - 8: d1-84: 2 x 100mg p.o.
Induction: Cycles 1 + 2: --; Cycle 3: d1-7: 20mg, d8-14: 50mg, d15-21: 100mg, d22-28: 200mg p.o.; Cycle 4 - 6: d1-28: 400 mg p.o.
Maintenance: Cycle 1 - 8: d1-84: 400 mg p.o.
- Negativity rate of minimal residual disease (MRD) in peripheral blood (PB) measured by 4-color flow cytometry [ Time Frame: At final restaging (RE): 12 weeks after the start of the last induction cycle ]MRD negativity is defined as less than one (1) CLL-cell among 10,000 leukocytes analyzed [0.01%], i.e. < 10-4. The MRD negativity rate is defined as the proportion of patients having achieved MRD negativity based on the full analysis set (FAS).
- Overall response rate (ORR) [ Time Frame: At final restaging (RE): 12 weeks after the start of the last induction cycle ]Proportion of patients having achieved a complete response (CR), a CR with incomplete recovery of the bone marrow (CRi), or a partial response(PR) as best response.
- CR / CRi rate [ Time Frame: At final restaging (RE): 12 weeks after the start of the last induction cycle ]Proportion of patients having achieved a CR or CRi as best response
- MRD in PB measured by 4-color flow cytometry at different times: At screening, after debulking, 4-weekly during induction, at initial response assessment (after 6 induction cycles), at RE, every 12 weeks during maintenance and follow up. [ Time Frame: From date of screening until the end of follow-up, up to 40 month. ]MRD negativity is defined as less than one (1) CLL-cell among 10,000 leukocytes analyzed [0.01%], i.e. < 10-4. MRD values will be categorized into negative (<10-4) and positive (≥10-4)
- Safety: Adverse events (AE), serious adverse events (SAE) and adverse events of particular interest (AEPI) [ Time Frame: up to 40 months after first dose of study drug ]Type, frequency, and severity of AEs, SAEs and AESIs and their relationship to study treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787264
|Contact: Paula Cramer, Dr. med.||+49 221 478 firstname.lastname@example.org|
|Contact: Moritz Fürstenau, Dr. med.||+49 221 478 email@example.com|
|Ulm, Germany, 89070|
|Principal Investigator:||Paula Cramer, Dr. med.||German CLL Study Group|