Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL (ElevateTN)

August 26, 2025 updated by: Acerta Pharma BV

A Randomized, Multicenter, Open-Label, 3 Arm Phase 3 Study of Obinutuzumab in Combination With Chlorambucil, Acalabrutinib (ACP-196) in Combination With Obinutuzumab, and Acalabrutinib Monotherapy in Subjects With Previously Untreated CLL

This Primary objective is evaluating the efficacy of obinutuzumab in combination with chlorambucil (Arm A) compared with acalabrutinib in combination with obinutuzumab (Arm B) for the treatment of previously untreated chronic lymphocytic leukemia (CLL). Secondary objectives: 1) To evaluate the efficacy of obinutuzumab in combination with chlorambucil (Arm A) versus acalabrutinib monotherapy (Arm C) based on IRC assessment of PFS per IWCLL 2008 criteria.

2)To compare obinutuzumab plus chlorambucil (Arm A) versus acalabrutinib plus obinutuzumab (Arm B) and obinutuzumab plus chlorambucil (Arm A) versus acalabrutinib monotherapy (Arm C) in terms of: IRC-assessed objective response rate (ORR); Tine to next treatment (TTNT); Overall Survival (OS)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

ELEVATE-TN is a global, phase 3, multicenter, open-label study in patients with treatment-naive chronic lymphocytic leukemia (CLL). Study enrollment is completed. The study randomized a total of 535 subjects in 142 study sites in 18 countries between 14 September 2015 through 08 February 2017. Patients were randomly assigned to receive Acalabrutinib and Obinutuzumab, Acalabrutinib monotherapy, or Obinutuzumab and oral Chlorambucil. The primary endpoint was progression-free survival between the two combination-therapy groups, defined as the time from randomization until disease progression by use of iwCLL 2008 criteria, or death, assessed by independent review committee (IRC). Crossover to Acalabrutinib was allowed in patients who progressed on Obinutuzumab-Chlorambucil.

The results of this study provide new evidence for therapy in patients with treatment-naive chronic lymphocytic leukemia by showing the efficacy of Acalabrutinib used with or without Obinutuzumab compared with chemoimmunotherapy.

Currently the study is in maintenance phase, with more than 430 subjects on study, to generate more evidence. We are not expecting any significant change in the near future.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
535

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Darlinghurst, Australia, 2010
        • Research Site
      • Frankston, Australia, 3199
        • Research Site
      • Geelong, Australia, 3220
        • Research Site
      • South Brisbane, Australia, QLD 4101
        • Research Site
      • Waratah NSW, Australia, 2298
        • Research Site
      • Wollongong, Australia, 2500
        • Research Site
      • Woodville, Australia, 5011
        • Research Site
  • Belgium
      • Bruges, Belgium, 8000
        • Research Site
      • Brussels, Belgium, 1090
        • Research Site
      • Brussels, Belgium, 1200
        • Research Site
      • Ghent, Belgium, 9000
        • Research Site
      • Kortrijk, Belgium, 8500
        • Research Site
      • Leuven, Belgium, 3000
        • Research Site
      • Roeselare, Belgium, 8900
        • Research Site
      • Wilrijk, Belgium, 2610
        • Research Site
      • Yvoir, Belgium, 5530
        • Research Site
  • Brazil
      • Barretos, Brazil, 14784-400
        • Research Site
      • Florianópolis, Brazil, 88034-000
        • Research Site
      • Passo Fundo, Brazil, 99010-260
        • Research Site
      • Porto Alegre, Brazil, 90035-903
        • Research Site
      • Porto Alegre, Brazil, 90470-340
        • Research Site
      • São Paulo, Brazil, 155
        • Research Site
  • Canada
      • Québec, Canada, G1J 1Z4
        • Research Site
      • Saint John, Canada, E2L 4L2
        • Research Site
      • Winnipeg, Canada, R3E 0V9
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H2Y9
        • Research Site
  • Chile
      • Santiago, Chile, 8380455
        • Research Site
      • Temuco, Chile, 4810469
        • Research Site
  • Colombia
      • Medellín, Colombia, 050034
        • Research Site
      • Montería, Colombia, 110221
        • Research Site
  • France
      • Bobigny, France, 93000
        • Research Site
      • Dijon, France, 21000
        • Research Site
      • Pierre-Bénite, France, 69310
        • Research Site
      • Strasbourg, France, 67098
        • Research Site
      • Villejuif, France, 94800
        • Research Site
  • Germany
      • Aschaffenburg, Germany, 63739
        • Research Site
      • Bielefeld, Germany, 33604
        • Research Site
      • Erlangen, Germany, 91052
        • Research Site
      • Heilbronn, Germany, 74078
        • Research Site
      • Warzburg, Germany, 97080
        • Research Site
  • Hungary
      • Budapest, Hungary, 1085
        • Research Site
      • Budapest, Hungary, 1122
        • Research Site
      • Debrecen, Hungary, 4032
        • Research Site
      • Kaposvár, Hungary, 7400
        • Research Site
      • Szolnok, Hungary, 5004
        • Research Site
  • Israel
      • Ashkelon, Israel, 7830604
        • Research Site
      • Beersheba, Israel, 84101
        • Research Site
      • Haifa, Israel, 34362
        • Research Site
      • Haifa, Israel, 31096
        • Research Site
      • Haifa, Israel, 31000
        • Research Site
      • Jerusalem, Israel, 9103102
        • Research Site
      • Nahariya, Israel, 22100
        • Research Site
      • Petah Tikvah, Israel, 49102
        • Research Site
      • Petah Tikvah, Israel, 49100
        • Research Site
      • Rehovot, Israel, 76100
        • Research Site
      • Tel Aviv, Israel, 64239
        • Research Site
      • Tel Litwinsky, Israel, 52621
        • Research Site
      • Tiberias, Israel, 15208
        • Research Site
  • Italy
      • Alessandria, Italy, 15100
        • Research Site
      • Aviano, Italy, 33081
        • Research Site
      • Brescia, Italy, 25123
        • Research Site
      • Florence, Italy, 50134
        • Research Site
      • Meldola, Italy, 47014
        • Research Site
      • Milan, Italy, 20132
        • Research Site
      • Parma, Italy
        • Research Site
      • Ravenna, Italy, 48121
        • Research Site
      • Rimini, Italy, 47900
        • Research Site
      • Rome, Italy, 168
        • Research Site
      • Rozzano, Italy, 20089
        • Research Site
  • Lithuania
      • Kaunas, Lithuania, LT-50009
        • Research Site
      • Klaipėda, Lithuania, LT-92288
        • Research Site
      • Vilnius, Lithuania, LT-08661
        • Research Site
  • New Zealand
      • Auckland, New Zealand, ?0620
        • Research Site
      • Otahuhu, New Zealand, 2025
        • Research Site
      • Tauranga, New Zealand, 3112
        • Research Site
  • Poland
      • Bydgoszcz, Poland, 85-168
        • Research Site
      • Gdansk, Poland, 80-129
        • Research Site
      • Gdynia, Poland, 81-519
        • Research Site
      • Krakow, Poland, 30-727
        • Research Site
      • Lodz, Poland, 93-510
        • Research Site
      • Lublin, Poland, 20-081
        • Research Site
      • Olsztyn, Poland, 10-228
        • Research Site
      • Opole, Poland, 46-020
        • Research Site
      • Słupsk, Poland, 76-200
        • Research Site
  • Spain
      • Barcelona, Spain, ?08041
        • Research Site
      • Madrid, Spain, 28031
        • Research Site
      • Madrid, Spain, 28041
        • Research Site
      • Madrid, Spain, 28006
        • Research Site
      • Majadahonda, Spain, 28222
        • Research Site
      • Santander, Spain, 39008
        • Research Site
  • Sweden
      • Gothenburg, Sweden, 41345
        • Research Site
      • Linköping, Sweden, 58185
        • Research Site
      • Lund, Sweden, SE-22185
        • Research Site
      • Örebro, Sweden, 701 85
        • Research Site
  • United Kingdom
      • Bournemouth, United Kingdom, BH7 7DW
        • Research Site
      • Cambridge, United Kingdom, CB2 0QQ
        • Research Site
      • Leeds, United Kingdom, LS9 7TF
        • Research Site
      • Leicester, United Kingdom, LE1 7RH
        • Research Site
      • London, United Kingdom, SE5 9RS
        • Research Site
      • Plymouth, United Kingdom, PL6 8DH
        • Research Site
      • Southampton, United Kingdom, SO16 6YD
        • Research Site
      • Truro, United Kingdom, TR1 3LJ
        • Research Site
      • Wolverhampton, United Kingdom, WV10 0QP
        • Research Site
  • United States
    • Arizona
      • Goodyear, Arizona, United States, 85395
        • Research Site
      • Phoenix, Arizona, United States, 85016
        • Research Site
    • California
      • Anaheim, California, United States, 92801
        • Research Site
      • Los Angeles, California, United States, 90017
        • Research Site
      • Los Angeles, California, United States, 90095
        • Research Site
      • Los Angeles, California, United States, 90033
        • Research Site
      • Oxnard, California, United States, 93030
        • Research Site
      • Palo Alto, California, United States, 94304
        • Research Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Research Site
      • Lone Tree, Colorado, United States, 80124
        • Research Site
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Research Site
    • Florida
      • Fort Myers, Florida, United States, 33901-8101
        • Research Site
      • Jacksonville, Florida, United States, 32224
        • Research Site
      • Tallahassee, Florida, United States, 32308
        • Research Site
      • Tallahassee, Florida, United States, 32308-5304
        • Research Site
      • Tampa, Florida, United States, 33612
        • Research Site
    • Illinois
      • Niles, Illinois, United States, 60714
        • Research Site
    • Indiana
      • Lafayette, Indiana, United States, 47904
        • Research Site
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Research Site
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Research Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Research Site
    • Maryland
      • COL, Maryland, United States, 21044
        • Research Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Research Site
      • Saint Cloud, Minnesota, United States, 56303
        • Research Site
    • Montana
      • Billings, Montana, United States, 59102
        • Research Site
    • New Jersey
      • Brick, New Jersey, United States, 08724
        • Research Site
      • Hackensack, New Jersey, United States, ?07601
        • Research Site
    • New York
      • Lake Success, New York, United States, 11042
        • Research Site
      • New York, New York, United States, 10029
        • Research Site
    • Ohio
      • Blue Ash, Ohio, United States, 45242
        • Research Site
      • Canton, Ohio, United States, 44719
        • Research Site
      • Columbus, Ohio, United States, 43210
        • Research Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Research Site
    • Texas
      • Austin, Texas, United States, 78705
        • Research Site
      • Bedford, Texas, United States, 76022
        • Research Site
      • Dallas, Texas, United States, 75230
        • Research Site
      • Fort Sam Houston, Texas, United States, 78234
        • Research Site
      • Houston, Texas, United States, 77030
        • Research Site
      • New Braunfels, Texas, United States, 78130
        • Research Site
      • Round Rock, Texas, United States, 76508
        • Research Site
      • San Antonio, Texas, United States, 78258
        • Research Site
      • Texas City, Texas, United States, 77591
        • Research Site
      • Tyler, Texas, United States, 75702
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Research Site
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Research Site
    • Washington
      • Seattle, Washington, United States, 98122
        • Research Site
      • Seattle, Washington, United States, 98109
        • Research Site
      • Spokane, Washington, United States, 99208
        • Research Site
      • Tacoma, Washington, United States, 98405
        • Research Site
      • Yakima, Washington, United States, 98902
        • Research Site
    • Wisconsin
      • Northwest WA, Wisconsin, United States, 20007
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  1. Men and women:

    a. ≥ 65 years of age OR b. > 18 and < 65 years of age, provided that they meet at least one of the following criteria: i. Creatinine clearance 30 to 69 mL/min using the Cockcroft-Gault equation ii. A score higher than 6 on the CIRS-G (Appendix L).

  2. ECOG performance status of 0, 1, or 2.

  3. Diagnosis of CD20+ CLL that meets published diagnostic criteria (Hallek 2008):

    1. Monoclonal B cells (either kappa or lambda light chain restricted) that are clonally co-expressing ≥ 1 B-cell marker (CD19, CD20, or CD23) and CD5.
    2. Prolymphocytes may comprise ≤ 55% of blood lymphocytes.
    3. Presence of ≥ 5 x 109 B lymphocytes/L (5000 μL) in the peripheral blood (at any point since diagnosis)

  4. Active disease meeting ≥ 1 of the following IWCLL 2008 criteria for requiring treatment:

    1. Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia (hemoglobin < 10 g/dL) and/or thrombocytopenia (platelets < 100,000/μL).
    2. Massive (i.e., ≥ 6 cm below the left costal margin), progressive, or symptomatic splenomegaly.
    3. Massive nodes (i.e., ≥ 10 cm in the longest diameter), progressive, or symptomatic lymphadenopathy.
    4. Progressive lymphocytosis with an increase of > 50% over a 2-month period or a LDT of < 6 months. LDT may be obtained by linear regression extrapolation of ALC obtained at intervals of 2 weeks over an observation period of 2 to 3 months. In subjects with initial blood lymphocyte counts of < 30 x 109/L (30,000/μL), LDT should not be used as a single parameter to define indication for treatment. In addition, factors contributing to lymphocytosis or lymphadenopathy other than CLL (e.g., infections) should be excluded.
    5. Autoimmune anemia and/or thrombocytopenia that is poorly responsive to standard therapy.
    6. Constitutional symptoms documented in the subject's chart with supportive objective measures, as appropriate, defined as ≥ 1 of the following disease-related symptoms or signs:

    i. Unintentional weight loss ≥ 10% within the previous 6 months before Screening.

    ii. Significant fatigue (i.e., ECOG performance status 2; inability to work or perform usual activities).

    iii. Fevers higher than 100.5°F or 38.0°C for 2 or more weeks before Screening without evidence of infection.

    iv. Night sweats for > 1 month before Screening without evidence of infection.

  5. This criterion was deleted as of Protocol Amendment 3.

  6. Meet the following laboratory parameters:

    1. ANC ≥ 750 cells/μL (0.75 x 109/L), or ≥ 500 cells/μL (0.50 x 109/L) in subjects with documented bone marrow involvement, and independent of growth factor support 7 days before assessment.
    2. Platelet count ≥ 50,000 cells/μL (50 x 109/L), or ≥ 30,000 cells/μL (30 x 109/L) in subjects with documented bone marrow involvement, and without transfusion support 7 days before assessment. Subjects with transfusion-dependent thrombocytopenia are excluded.
    3. Serum AST and ALT/SGPT ≤ 3.0 x ULN.
    4. Total bilirubin ≤ 1.5 x ULN.
    5. Estimated creatinine clearance (i.e., eGFR using Cockcroft-Gault) ≥ 30 mL/min
  7. Able to receive all outpatient treatment, all laboratory monitoring, and all radiologic evaluations.
  8. Women who are sexually active and can bear children must agree to use highly effective forms of contraception while on the study and for 2 days after the last dose of acalabrutinib or 18 months after the last dose of obinutuzumab in combination with chlorambucil, whichever is longer. Highly effective forms of contraception are defined in Section 6.4.4.
  9. Men who are sexually active and can beget children must agree to use highly effective forms of contraception during the study and for 90 days after the last dose of obinutuzumab or chlorambucil, whichever is later. Highly effective forms of contraception are defined in Section 6.4.4.
  10. Men must agree to refrain from sperm donation during the study and for 90 days after the last dose of obinutuzumab or chlorambucil, whichever is later.
  11. Must be willing and able to adhere to the study visit schedule, understand and comply with other protocol requirements, and provide written informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations). Note vulnerable subjects, as defined in International Conference on Harmonisation (ICH) GCP, are not allowed on this protocol (e.g., prisoners or institutionalized subjects).

Exclusion Criteria:

  1. Any prior systemic treatment for CLL (note: Prior localized radiotherapy is allowed).
  2. Known CNS lymphoma or leukemia.
  3. Known prolymphocytic leukemia or history of, or currently suspected, Richter's syndrome.
  4. Missing or incomplete documentation of FISH results reflecting the presence or absence of 17p del and the percentage of cells with the deletion in subject records before randomization.
  5. Uncontrolled AIHA or ITP defined as declining hemoglobin or platelet count secondary to autoimmune destruction within the screening period or requirement for high doses of steroids (> 20 mg daily of prednisone daily or equivalent).
  6. Corticosteroid use > 20 mg within 1 week before first dose of study drug, except as indicated for other medical conditions such as inhaled steroid for asthma, topical steroid use, or as premedication for administration of study drug or contrast. For example, subjects requiring steroids at daily doses > 20 mg prednisone equivalent systemic exposure daily, or those who are administered steroids for leukemia control or WBC count lowering are excluded.
  7. Major surgery within 4 weeks before first dose of study drug.

  8. History of prior malignancy except for the following:

    1. Malignancy treated with curative intent and with no evidence of active disease present for more than 3 years before Screening and felt to be at low risk for recurrence by treating physician.
    2. Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled non-melanomatous skin cancer.
    3. Adequately treated cervical carcinoma in situ without current evidence of disease.
  9. Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or QTc > 480 msec at screening.
  10. Unable to swallow capsules or malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or gastric bypass, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
  11. Uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment) or ongoing intravenous anti-infective treatment.
  12. Known history of infection with HIV. 13. Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug.

14. Serologic status reflecting active hepatitis B or C infection. Subjects with hepatitis B core antibody positive who are surface antigen negative or who are hepatitis C antibody positive will need to have a negative PCR result before randomization. Those who are hepatitis B surface antigen positive or hepatitis B PCR positive and those who are hepatitis C PCR positive will be excluded.

15. History of stroke or intracranial hemorrhage within 6 months before randomization.

16. Known history of a bleeding diathesis (e.g., hemophilia, von Willebrand disease).

17. Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon) within 7 days of first dose of study drug.

18. Requires treatment with proton-pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole).

19. Breast feeding or pregnant. 20. Current life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the subject's safety or put the study at risk.

21. Concurrent participation in another therapeutic clinical trial. 22. Requires treatment with a strong CYP3A inhibitor/inducer. 23. Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Arm A - Obinutuzumab in Combination with Chlorambucil
Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles starting at Cycle 1 Day 1. Chlorambucil will be orally administered on Days 1 and 15 of Cycles 1 through 6.
Drug: Obinutuzumab
Other Names:
  • GAZYVA / GAZYVARO
Drug: Chlorambucil
Other Names:
  • LEUKERAN
Experimental: Arm B - Acalabrutinib in Combination with Obinutuzumab
Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles starting at Cycle 2 Day 1. Acalabrutinib (ACP-196) will be orally administered starting on Cycle 1 Day 1. Daily administration of Acalabrutinib (ACP-196) will continue until disease progression or unacceptable toxicity.
Drug: Acalabrutinib
Other Names:
  • ACP-196 (Calquence)
Drug: Obinutuzumab
Other Names:
  • GAZYVA / GAZYVARO
Experimental: Arm C - Acalabrutinib Monotherapy
Acalabrutinib (ACP-196) will be orally administered on Cycle 1 Day 1 until disease progression or unacceptable toxicity.
Drug: Acalabrutinib
Other Names:
  • ACP-196 (Calquence)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression-free Survival by IRC (Independent Review Committee) Assessment in Arm A Compared to Arm B
Time Frame: IRC assessments were done from randomization date until disease progression or death or IRC discontinuation date on 08Feb2019 (as the IA based on this data cutoff date showed the study crossing superiority boundary) whichever comes first up to 40 months.
To evaluate the efficacy of obinutuzumab in combination with chlorambucil (Arm A) compared with acalabrutinib in combination with obinutuzumab (Arm B) based on IRC assessment of progression-free survival (PFS) per International Workshop on Chronic Lymphocytic Leukemia criteria (IWCLL; Hallek et al. 2008) with incorporation of the clarification for treatment-related lymphocytosis (Cheson et al. 2012), hereafter referred to as IWCLL 2008 criteria, in subjects with previously untreated CLL. PFS, defined as the time from date of randomization to the date of first IRC-assessed disease progression or death due to any cause, whichever comes first.
IRC assessments were done from randomization date until disease progression or death or IRC discontinuation date on 08Feb2019 (as the IA based on this data cutoff date showed the study crossing superiority boundary) whichever comes first up to 40 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression-free Survival by IRC Assessment Arm A Versus Arm C
Time Frame: IRC assessments were done from randomization date until disease progression or death or IRC discontinuation date on 08Feb2019 (as the IA based on this data cutoff date showed the study crossing superiority boundary) whichever comes first up to 40 months.
To evaluate the efficacy of obinutuzumab in combination with chlorambucil (Arm A) compared with acalabrutinib monotherapy (Arm C) based on IRC assessment of progression-free survival (PFS) per International Workshop on Chronic Lymphocytic Leukemia criteria (IWCLL; Hallek et al. 2008) with incorporation of the clarification for treatment-related lymphocytosis (Cheson et al. 2012), hereafter referred to as IWCLL 2008 criteria, in subjects with previously untreated CLL. PFS, defined as the time from date of randomization to the date of first IRC-assessed disease progression or death due to any cause, whichever comes first.
IRC assessments were done from randomization date until disease progression or death or IRC discontinuation date on 08Feb2019 (as the IA based on this data cutoff date showed the study crossing superiority boundary) whichever comes first up to 40 months.
IRC-assessed Objective Response Rate (ORR) in Arm A Versus Arm B and Arm A Versus Arm C
Time Frame: IRC assessments were done from randomization date until disease progression or death or IRC discontinuation date on 08Feb2019 (as the IA based on this data cutoff date showed the study crossing superiority boundary) whichever comes first up to 40 months.
ORR was defined as the proportion of subjects who achieved a best response of CR, CRi, nPR, or PR at or before initiation of subsequent anticancer therapy. ORR including PRL was defined as the proportion of subjects who achieved a best response of CR, CRi, nPR, PR or PRL at or before initiation of subsequent anticancer therapy
IRC assessments were done from randomization date until disease progression or death or IRC discontinuation date on 08Feb2019 (as the IA based on this data cutoff date showed the study crossing superiority boundary) whichever comes first up to 40 months.
Time to Next Treatment (TTNT) in Arm A Versus Arm B and Arm A Versus Arm C
Time Frame: From randomization date to start of non-protocol specified subsequent anticancer therapy for CLL or death due to any cause, whichever came first assessed up to 40 months of follow-up.
TTNT was defined as the time from randomization to start date of non-protocol specified subsequent anticancer therapy for CLL or death due to any cause, whichever came first. TTNT was analyzed in the same fashion as that for the primary efficacy analysis
From randomization date to start of non-protocol specified subsequent anticancer therapy for CLL or death due to any cause, whichever came first assessed up to 40 months of follow-up.
Overall Survival (OS) in Arm A Versus Arm B and Arm A Versus Arm C
Time Frame: From randomization date until death, withdrawal by subject, lost to follow-up, or by analysis data cut off date on 08Feb2019 whichever comes first up to 40 months of follow-up.
OS was defined as the time from the date of randomization to death due to any cause.
From randomization date until death, withdrawal by subject, lost to follow-up, or by analysis data cut off date on 08Feb2019 whichever comes first up to 40 months of follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Acerta Pharma BV

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: AstraZeneca Clinical study Information Center, 1-877-240-9479 information.center@astrazeneca.com

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 26, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 8, 2019

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2015

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ACE-CL-007
  • 2014-005582-73 (EudraCT Number)
  • 2023-509348-84-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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