<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03787264</url>
  </required_header>
  <id_info>
    <org_study_id>CLL2-BAAG</org_study_id>
    <nct_id>NCT03787264</nct_id>
  </id_info>
  <brief_title>Sequential Regimen of Bendamustin-Debulking Followed by Obinutuzumab, Acalabrutinib and Venetoclax in Patients With Relapsed/Refractory CLL</brief_title>
  <acronym>CLL2-BAAG</acronym>
  <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)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>German CLL Study Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>German CLL Study Group</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      CLL2-BAAG is a prospective, open-label, multicenter phase-II trial to evaluate the efficacy&#xD;
      and safety of a sequential regimen of debulking with bendamustine followed by induction and&#xD;
      maintenance with GA101 (obinutuzumab), acalabrutinib (ACP-196) and venetoclax (ABT-199) in&#xD;
      patients with relapsed/refractory CLL.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the CLL2-BAAG trial will be included a total of 46 patients with relapsed or refractory&#xD;
      CLL in need of treatment.This trial will evaluate a debulking with two cycles bendamustine&#xD;
      (only for patients with a higher tumor load), followed by an induction and a maintenance&#xD;
      treatment with obinutuzumab, acalabrutinib and venetoclax in patients with&#xD;
      re-lapsed/refractory CLL. The duration of maintenance treatment is depending on MRD levels.&#xD;
      This trial combines one old (chemotherapy) and three novel, synergistic (antibody,&#xD;
      BTK-inhibitor and Bcl-2 antagonist) principles of action in order to achieve deep and long&#xD;
      lasting remissions with a short duration of treatment. Additionally, this trial has an&#xD;
      extensive accompanying scientific program aiming at a better understanding of the kinetics of&#xD;
      response and clonal evolution of CLL.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 14, 2019</start_date>
  <completion_date type="Anticipated">October 2023</completion_date>
  <primary_completion_date type="Actual">February 11, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Negativity rate of minimal residual disease (MRD) in peripheral blood (PB) measured by 4-color flow cytometry</measure>
    <time_frame>At final restaging (RE): 12 weeks after the start of the last induction cycle</time_frame>
    <description>MRD negativity is defined as less than one (1) CLL-cell among 10,000 leukocytes analyzed [0.01%], i.e. &lt; 10-4. The MRD negativity rate is defined as the proportion of patients having achieved MRD negativity based on the full analysis set (FAS).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall response rate (ORR)</measure>
    <time_frame>At final restaging (RE): 12 weeks after the start of the last induction cycle</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CR / CRi rate</measure>
    <time_frame>At final restaging (RE): 12 weeks after the start of the last induction cycle</time_frame>
    <description>Proportion of patients having achieved a CR or CRi as best response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <time_frame>From date of screening until the end of follow-up, up to 40 month.</time_frame>
    <description>MRD negativity is defined as less than one (1) CLL-cell among 10,000 leukocytes analyzed [0.01%], i.e. &lt; 10-4. MRD values will be categorized into negative (&lt;10-4) and positive (≥10-4)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety: Adverse events (AE), serious adverse events (SAE) and adverse events of particular interest (AEPI)</measure>
    <time_frame>up to 40 months after first dose of study drug</time_frame>
    <description>Type, frequency, and severity of AEs, SAEs and AESIs and their relationship to study treatment.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Chronic Lymphoid Leukemia</condition>
  <arm_group>
    <arm_group_label>BAAG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Debulking: 2 debulking cycles (q 28d) of bendamustine will be administered unless the patient has a contraindication or a debulking is not clinically indicated&#xD;
Induction: 6 cycles (q 28d) of Obinutuzumab + Acalabrutinib + Venetoclax&#xD;
Maintenance: max. 8 cycles (q 84d) of Obinutuzumab + Acalabrutinib + Venetoclax&#xD;
Maintenance treatment will be continued until (whichever occurs first):&#xD;
12 weeks (approx. 3 months) after confirmation of achievement of a CR/CRi and MRD negativity&#xD;
maintenance cycle 8&#xD;
progression of CLL or start of a subsequent therapy&#xD;
unacceptable toxicity</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bendamustine</intervention_name>
    <description>Debulking: Cycles 1-2: d1+2 - 70mg/m² i.v.</description>
    <arm_group_label>BAAG</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Obinutuzumab</intervention_name>
    <description>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.&#xD;
Maintenance: Cycle 1 - 8: 1000 mg, d1 i.v.</description>
    <arm_group_label>BAAG</arm_group_label>
    <other_name>GA101</other_name>
    <other_name>Gazyvaro</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Acalabrutinib</intervention_name>
    <description>Induction: Cycle 1: --; Cycles 2 - 6: d1-28: 2 x 100mg p.o.&#xD;
Maintenance: Cycle 1 - 8: d1-84: 2 x 100mg p.o.</description>
    <arm_group_label>BAAG</arm_group_label>
    <other_name>ACP-196</other_name>
    <other_name>Calquence</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Venetoclax</intervention_name>
    <description>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.&#xD;
Maintenance: Cycle 1 - 8: d1-84: 400 mg p.o.</description>
    <arm_group_label>BAAG</arm_group_label>
    <other_name>ABT-199</other_name>
    <other_name>Venclyxto</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Relapsed/refractory CLL in need of treatment according to iwCLL (international&#xD;
             workshop on CLL) criteria&#xD;
&#xD;
             In case of a recent previous treatment, patients must have recovered from acute&#xD;
             toxicities and treatment regimen must be stopped within the following time periods&#xD;
             before start of the study treatment in the CLL2-BAAG trial:&#xD;
&#xD;
               -  chemotherapy ≥ 28 days&#xD;
&#xD;
               -  antibody treatment ≥ 14 days&#xD;
&#xD;
               -  kinase inhibitors, BCL2-antagonists or immuno-modulatory agents ≥ 3 days&#xD;
&#xD;
               -  corticosteroids may be applied until the start of the BAAG-regimen, these have to&#xD;
                  be reduced to an equivalent of ≤ 20mg prednisolone per day during treatment&#xD;
                  Please note: Patients with a progression during previous treatment with&#xD;
                  venetoclax, ibrutinib or another BTK inhibitor, as well as patients with a known&#xD;
                  resistance mutation (e.g. BTK-/PLCg2) are excluded from study participation.&#xD;
                  However, patients who progressed after termination of treatment with venetoclax,&#xD;
                  ibrutinib, other BTK inhibitors and/or obinutuzumab or who stopped treatment due&#xD;
                  to in-tolerance to ibrutinib are eligible for participation.&#xD;
&#xD;
          2. Adequate renal function, as indicated by a creatinine clearance ≥30ml/min calculated&#xD;
             according to the modified formula of Cockcroft and Gault or directly measured with 24&#xD;
             hr. urine collection&#xD;
&#xD;
          3. Adequate hematologic function as indicated by a neutrophil count ≥ 1.0 x 109/L, a&#xD;
             hemoglobin value ≥8.0 g/dL and a platelet count ≥ 25 x 109/L, unless directly&#xD;
             attributable to the patient´s CLL (e.g. bone marrow infiltration), in this case,&#xD;
             platelet count should be ≥ 10 × 109/L.&#xD;
&#xD;
          4. Adequate liver function as indicated by a total bilirubin ≤2x, AST/ALT ≤2.5x the&#xD;
             institutional ULN value, unless directly attributable to the patient's CLL or to&#xD;
             Gilbert's Syndrome&#xD;
&#xD;
          5. Negative serological testing for hepatitis B (HBsAg nega-tive and anti-HBc negative,&#xD;
             patients positive for anti-HBc may be included if PCR for HBV DNA is negative and&#xD;
             HBV-DNA PCR is performed every 4 weeks until one year after last dosage of GA101&#xD;
             (obinutuzumab)), negative testing for hepatitis-C RNA and negative HIV test within 6&#xD;
             weeks prior to registration&#xD;
&#xD;
          6. Age ≥ 18 years&#xD;
&#xD;
          7. ECOG (Eastern Cooperative Oncology Group) performance status 0 - 2, ECOG 3 is only&#xD;
             permitted if related to CLL (e.g. due to anemia or severe constitutional symptoms)&#xD;
&#xD;
          8. Life expectancy ≥ 6 months&#xD;
&#xD;
          9. Ability and willingness to provide written informed consent and to adhere to the study&#xD;
             visit schedule and other proto-col requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. (Suspicion of) transformation of CLL (i.e. Richter's trans-formation, pro-lymphocytic&#xD;
             leukemia) or central nervous system (CNS) involvement&#xD;
&#xD;
          2. Progression during previous treatment with venetoclax, ibrutinib or another BTK&#xD;
             inhibitor, and/or presence of known mutations associated with resistance to therapy,&#xD;
             e.g. Bru-ton´s Tyrosine Kinase and Phospholipase C Gamma 2 (PLCg2)&#xD;
&#xD;
          3. Confirmed progressive multifocal leukoencephalopathy (PML)&#xD;
&#xD;
          4. Malignancies other than CLL currently requiring systemic therapies&#xD;
&#xD;
          5. Uncontrolled infection requiring systemic treatment&#xD;
&#xD;
          6. Any comorbidity or organ system impairment rated with a CIRS (cumulative illness&#xD;
             rating scale) score of 4, excluding the eyes/ears/nose/throat/larynx organ system1 or&#xD;
             any other life-threatening illness, medical condition or organ system dysfunction that&#xD;
             - in the investigator´s opinion - could compromise the patients safety or interfere&#xD;
             with the absorption or metabolism of the study drugs (e.g, inability to swallow&#xD;
             tablets or impaired resorption in the gastrointestinal tract)&#xD;
&#xD;
          7. Significantly increased risk of bleeding according to the investigator´s evaluation,&#xD;
             e.g. due known bleeding diathesis (e.g. von-Willebrandt´s disease or hemophilia),&#xD;
             major surgical procedure ≤ 4 weeks or stroke/intracranial hemorrhage ≤ 6 months.&#xD;
&#xD;
          8. Requirement of therapy with strong CYP3A4 inhibitors/inducers or anticoagulant with&#xD;
             phenprocoumon (marcumar) or other vitamin K-antagonists&#xD;
&#xD;
          9. Use of investigational agents ≤ 28 days prior to start of study treatment, however,&#xD;
             kinase inhibitors, BCL2-antagonists and antibody treatment are allowed in accordance&#xD;
             with inclusion criterion number 1 (see above).&#xD;
&#xD;
         10. Known hypersensitivity to obinutuzumab (GA101), venetoclax (ABT-199), acalabrutinib&#xD;
             (ACP-196) or any of the excipients Please note: Patients with a known hypersensitivity&#xD;
             to bendamustine are allowed to participate but will not receive a debulking with&#xD;
             bendamustine&#xD;
&#xD;
         11. Pregnant women and nursing mothers (a negative preg-nancy test is required for all&#xD;
             women of childbearing potential within 7 days before start of treatment)&#xD;
&#xD;
         12. Fertile men or women of childbearing potential unless:&#xD;
&#xD;
               -  surgically sterile or ≥ 2 years after the onset of menopause, or&#xD;
&#xD;
               -  willing to use two methods of reliable contraception including one highly&#xD;
                  effective (Pearl Index &lt;1) and one additional effective (barrier) method during&#xD;
                  study treatment and for 18 months after end of study treatment.&#xD;
&#xD;
         13. Vaccination with a live vaccine ≤ 28 days prior to registration&#xD;
&#xD;
         14. Legal incapacity&#xD;
&#xD;
         15. Prisoners or subjects who are institutionalized by regula-tory or court order&#xD;
&#xD;
         16. Persons who are in dependence to the sponsor or an investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paula Cramer, Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>German CLL Study Group</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gemeinschaftspraxis Hämatologie Onkologie</name>
      <address>
        <city>Dresden</city>
        <zip>1307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gemeinschaftspraxis Mohm/Prange-Krex</name>
      <address>
        <city>Dresden</city>
        <zip>1307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinik Carl Gustav Carus</name>
      <address>
        <city>Dresden</city>
        <zip>1307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helios Klinikum Erfurt</name>
      <address>
        <city>Erfurt</city>
        <zip>99089</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Jena</name>
      <address>
        <city>Jena</city>
        <zip>7747</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis fuer Haematologie und Onkologie</name>
      <address>
        <city>Koblenz</city>
        <zip>56068</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinik Köln</name>
      <address>
        <city>Köln</city>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gemeinschaftspraxis Haemato/ Onkologie Lebach</name>
      <address>
        <city>Lebach</city>
        <zip>66822</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Leverkusen GmbH</name>
      <address>
        <city>Leverkusen</city>
        <zip>51375</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krankenhaus Muenchen-Schwabing</name>
      <address>
        <city>Munich</city>
        <zip>80804</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ludwig-Maximilians-Universitaet Muenchen</name>
      <address>
        <city>München</city>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Dr. Uhlig</name>
      <address>
        <city>Naunhof</city>
        <zip>4683</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinik Rostock</name>
      <address>
        <city>Rostock</city>
        <zip>18057</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ZAHO-Rheinland</name>
      <address>
        <city>Siegburg</city>
        <zip>53721</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinik Tuebingen</name>
      <address>
        <city>Tübingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Ulm</name>
      <address>
        <city>Ulm</city>
        <zip>89081</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://www.dcllsg.de/en/trial/cll2-baag/index.php</url>
    <description>Click here for more information about this study: CLL2-BAAG (German CLL Study Group)</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 22, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>July 4, 2023</last_update_submitted>
  <last_update_submitted_qc>July 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia, Lymphoid</mesh_term>
    <mesh_term>Leukemia, Lymphocytic, Chronic, B-Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Venetoclax</mesh_term>
    <mesh_term>Bendamustine Hydrochloride</mesh_term>
    <mesh_term>Obinutuzumab</mesh_term>
    <mesh_term>Acalabrutinib</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03787264
org study id: CLL2-BAAG
nct id: NCT03787264
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
CLL2-BAAG is a prospective, open-label, multicenter phase-II trial to evaluate the efficacy
      and safety of a sequential regimen of debulking with bendamustine followed by induction and
      maintenance with GA101 (obinutuzumab), acalabrutinib (ACP-196) and venetoclax (ABT-199) in
      patients with relapsed/refractory CLL.
In the CLL2-BAAG trial will be included a total of 46 patients with relapsed or refractory
      CLL in need of treatment.This trial will evaluate a debulking with two cycles bendamustine
      (only for patients with a higher tumor load), followed by an induction and a maintenance
      treatment with obinutuzumab, acalabrutinib and venetoclax in patients with
      re-lapsed/refractory CLL. The duration of maintenance treatment is depending on MRD levels.
      This trial combines one old (chemotherapy) and three novel, synergistic (antibody,
      BTK-inhibitor and Bcl-2 antagonist) principles of action in order to achieve deep and long
      lasting remissions with a short duration of treatment. Additionally, this trial has an
      extensive accompanying scientific program aiming at a better understanding of the kinetics of
      response and clonal evolution of CLL.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 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
description: 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).
measure: Overall response rate (ORR)
time frame: At final restaging (RE): 12 weeks after the start of the last induction cycle
description: 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.
measure: CR / CRi rate
time frame: At final restaging (RE): 12 weeks after the start of the last induction cycle
description: Proportion of patients having achieved a CR or CRi as best response
measure: 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.
description: 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)
measure: 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
description: Type, frequency, and severity of AEs, SAEs and AESIs and their relationship to study treatment.
arm group label: BAAG
arm group type: Experimental
description: 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):
12 weeks (approx. 3 months) after confirmation of achievement of a CR/CRi and MRD negativity
maintenance cycle 8
progression of CLL or start of a subsequent therapy
unacceptable toxicity
intervention type: Drug
intervention name: Bendamustine
description: Debulking: Cycles 1-2: d1+2 - 70mg/m² i.v.
arm group label: BAAG
intervention type: Biological
intervention name: Obinutuzumab
description: 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.
arm group label: BAAG
other name: GA101
other name: Gazyvaro
intervention type: Biological
intervention name: Acalabrutinib
description: Induction: Cycle 1: --; Cycles 2 - 6: d1-28: 2 x 100mg p.o.
Maintenance: Cycle 1 - 8: d1-84: 2 x 100mg p.o.
arm group label: BAAG
other name: ACP-196
other name: Calquence
intervention type: Biological
intervention name: Venetoclax
description: 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.
arm group label: BAAG
other name: ABT-199
other name: Venclyxto
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paula Cramer, Dr. med.
role: Principal Investigator
affiliation: German CLL Study Group
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country: Germany
url: http://www.dcllsg.de/en/trial/cll2-baag/index.php
description: Click here for more information about this study: CLL2-BAAG (German CLL Study Group)
responsible party type: Sponsor
mesh term: Leukemia, Lymphoid
mesh term: Leukemia, Lymphocytic, Chronic, B-Cell
mesh term: Venetoclax
mesh term: Bendamustine Hydrochloride
mesh term: Obinutuzumab
mesh term: Acalabrutinib