Sequential Regimen of Bendamustin-Debulking Followed by Obinutuzumab, Acalabrutinib and Venetoclax in Patients With Relapsed/Refractory CLL (CLL2-BAAG)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03787264|
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : January 24, 2019
|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.
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): 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|