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AzTrials

Chronic Lymphocytic LeukemiaPhase 3ElevateTNNCT02475681

Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL

A Phase 3 study testing Acalabrutinib, Obinutuzumab and Chlorambucil in people with Chronic Lymphocytic Leukemia, run by Acerta Pharma BV at 155 sites in 18 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
Acalabrutinib, Obinutuzumab and Chlorambucil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
535 participants
Where
155 sitesin 18 countries
Study dates
26 Jun 2015to 15 Sep 2026
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women:
  • ≥ 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).
  • ECOG performance status of 0, 1, or 2.
  • Diagnosis of CD20+ CLL that meets published diagnostic criteria (Hallek 2008):
  • 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.
  • Prolymphocytes may comprise ≤ 55% of blood lymphocytes.
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  • Presence of ≥ 5 x 109 B lymphocytes/L (5000 μL) in the peripheral blood (at any point since diagnosis)
  • Active disease meeting ≥ 1 of the following IWCLL 2008 criteria for requiring treatment:
  • 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).
  • Massive (i.e., ≥ 6 cm below the left costal margin), progressive, or symptomatic splenomegaly.
  • Massive nodes (i.e., ≥ 10 cm in the longest diameter), progressive, or symptomatic lymphadenopathy.
  • 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.
  • Autoimmune anemia and/or thrombocytopenia that is poorly responsive to standard therapy.
  • 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:
  • Unintentional weight loss ≥ 10% within the previous 6 months before Screening.
  • Significant fatigue (i.e., ECOG performance status 2; inability to work or perform usual activities).
  • Fevers higher than 100.5°F or 38.0°C for 2 or more weeks before Screening without evidence of infection.
  • Night sweats for > 1 month before Screening without evidence of infection.
  • This criterion was deleted as of Protocol Amendment 3.
  • Meet the following laboratory parameters:
  • 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.
  • 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.
  • Serum AST and ALT/SGPT ≤ 3.0 x ULN.
  • Total bilirubin ≤ 1.5 x ULN.
  • Estimated creatinine clearance (i.e., eGFR using Cockcroft-Gault) ≥ 30 mL/min
  • Able to receive all outpatient treatment, all laboratory monitoring, and all radiologic evaluations.
  • 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.
  • 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.
  • 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.
  • 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).

Who cannot join

  • Any prior systemic treatment for CLL (note: Prior localized radiotherapy is allowed).
  • Known CNS lymphoma or leukemia.
  • Known prolymphocytic leukemia or history of, or currently suspected, Richter's syndrome.
  • 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.
  • 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).
  • 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.
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  • Major surgery within 4 weeks before first dose of study drug.
  • History of prior malignancy except for the following:
  • 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.
  • Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled non-melanomatous skin cancer.
  • Adequately treated cervical carcinoma in situ without current evidence of disease.
  • 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.
  • 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.
  • 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.
  • 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.

Trial locations and contacts

155 sites in 18 countries.

155 sites in 18 countries

United States51 sites

  • Research Site

    Anaheim, California, 92801

  • Research Site

    Aurora, Colorado, 80045

  • Research Site

    Austin, Texas, 78705

  • Research Site

    Bedford, Texas, 76022

  • Research Site

    Billings, Montana, 59102

  • Research Site

    Blue Ash, Ohio, 45242

  • Research Site

    Brick, New Jersey, 08724

  • Research Site

    Canton, Ohio, 44719

  • Research Site

    COL, Maryland, 21044

  • Research Site

    Columbus, Ohio, 43210

  • Research Site

    Dallas, Texas, 75230

  • Research Site

    Fort Myers, Florida, 33901-8101

  • Research Site

    Fort Sam Houston, Texas, 78234

  • Research Site

    Goodyear, Arizona, 85395

  • Research Site

    Hackensack, New Jersey, ?07601

  • Research Site

    Houston, Texas, 77030

  • Research Site

    Jacksonville, Florida, 32224

  • Research Site

    Lafayette, Indiana, 47904

  • Research Site

    Lake Success, New York, 11042

  • Research Site

    Lone Tree, Colorado, 80124

  • Research Site

    Los Angeles, California, 90017

  • Research Site

    Los Angeles, California, 90033

  • Research Site

    Los Angeles, California, 90095

  • Research Site

    Louisville, Kentucky, 40207

  • Research Site

    Nashville, Tennessee, 37203

  • Research Site

    New Braunfels, Texas, 78130

  • Research Site

    New Orleans, Louisiana, 70112

  • Research Site

    New York, New York, 10029

  • Research Site

    Niles, Illinois, 60714

  • Research Site

    Northwest WA, Wisconsin, 20007

  • Research Site

    Oxnard, California, 93030

  • Research Site

    Palo Alto, California, 94304

  • Research Site

    Phoenix, Arizona, 85016

  • Research Site

    Roanoke, Virginia, 24014

  • Research Site

    Rochester, Minnesota, 55905

  • Research Site

    Round Rock, Texas, 76508

  • Research Site

    Saint Cloud, Minnesota, 56303

  • Research Site

    Salt Lake City, Utah, 84112

  • Research Site

    San Antonio, Texas, 78258

  • Research Site

    Seattle, Washington, 98109

  • Research Site

    Seattle, Washington, 98122

  • Research Site

    Spokane, Washington, 99208

  • Research Site

    Tacoma, Washington, 98405

  • Research Site

    Tallahassee, Florida, 32308-5304

  • Research Site

    Tallahassee, Florida, 32308

  • Research Site

    Tampa, Florida, 33612

  • Research Site

    Texas City, Texas, 77591

  • Research Site

    Tyler, Texas, 75702

  • Research Site

    Washington D.C., District of Columbia, 20007

  • Research Site

    Wichita, Kansas, 67214

  • Research Site

    Yakima, Washington, 98902

Other trials in United States

Israel13 sites

  • Research Site

    Ashkelon, 7830604

  • Research Site

    Beersheba, 84101

  • Research Site

    Haifa, 31000

  • Research Site

    Haifa, 31096

  • Research Site

    Haifa, 34362

  • Research Site

    Jerusalem, 9103102

  • Research Site

    Nahariya, 22100

  • Research Site

    Petah Tikvah, 49100

  • Research Site

    Petah Tikvah, 49102

  • Research Site

    Rehovot, 76100

  • Research Site

    Tel Aviv, 64239

  • Research Site

    Tel HaShomer, 52621

  • Research Site

    Tiberias, 15208

Other trials in Israel

Italy11 sites

  • Research Site

    Alessandria, 15100

  • Research Site

    Aviano, 33081

  • Research Site

    Brescia, 25123

  • Research Site

    Florence, 50134

  • Research Site

    Meldola, 47014

  • Research Site

    Milan, 20132

  • Research Site

    Parma

  • Research Site

    Ravenna, 48121

  • Research Site

    Rimini, 47900

  • Research Site

    Rome, 168

  • Research Site

    Rozzano, 20089

Other trials in Italy

Belgium9 sites

  • Research Site

    Bruges, 8000

  • Research Site

    Brussels, 1090

  • Research Site

    Brussels, 1200

  • Research Site

    Ghent, 9000

  • Research Site

    Kortrijk, 8500

  • Research Site

    Leuven, 3000

  • Research Site

    Roeselare, 8900

  • Research Site

    Wilrijk, 2610

  • Research Site

    Yvoir, 5530

Other trials in Belgium

Poland9 sites

  • Research Site

    Bydgoszcz, 85-168

  • Research Site

    Gdansk, 80-129

  • Research Site

    Gdynia, 81-519

  • Research Site

    Krakow, 30-727

  • Research Site

    Lodz, 93-510

  • Research Site

    Lublin, 20-081

  • Research Site

    Olsztyn, 10-228

  • Research Site

    Opole, 46-020

  • Research Site

    Słupsk, 76-200

Other trials in Poland

United Kingdom9 sites

  • Research Site

    Bournemouth, BH7 7DW

  • Research Site

    Cambridge, CB2 0QQ

  • Research Site

    Leeds, LS9 7TF

  • Research Site

    Leicester, LE1 7RH

  • Research Site

    London, SE5 9RS

  • Research Site

    Plymouth, PL6 8DH

  • Research Site

    Southampton, SO16 6YD

  • Research Site

    Truro, TR1 3LJ

  • Research Site

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Australia7 sites

  • Research Site

    Darlinghurst, 2010

  • Research Site

    Frankston, 3199

  • Research Site

    Geelong, 3220

  • Research Site

    South Brisbane, QLD 4101

  • Research Site

    Waratah NSW, 2298

  • Research Site

    Wollongong, 2500

  • Research Site

    Woodville, 5011

Other trials in Australia

Brazil6 sites

  • Research Site

    Barretos, 14784-400

  • Research Site

    Florianópolis, 88034-000

  • Research Site

    Passo Fundo, 99010-260

  • Research Site

    Porto Alegre, 90035-903

  • Research Site

    Porto Alegre, 90470-340

  • Research Site

    São Paulo, 155

Other trials in Brazil

Spain6 sites

  • Research Site

    Barcelona, ?08041

  • Research Site

    Madrid, 28006

  • Research Site

    Madrid, 28031

  • Research Site

    Madrid, 28041

  • Research Site

    Majadahonda, 28222

  • Research Site

    Santander, 39008

Other trials in Spain

Canada5 sites

  • Research Site

    Halifax, Nova Scotia, B3H2Y9

  • Research Site

    Québec, G1J 1Z4

  • Research Site

    Saint John, E2L 4L2

  • Research Site

    Vancouver, British Columbia, V5Z 4E6

  • Research Site

    Winnipeg, R3E 0V9

Other trials in Canada

France5 sites

  • Research Site

    Bobigny, 93000

  • Research Site

    Dijon, 21000

  • Research Site

    Pierre-Bénite, 69310

  • Research Site

    Strasbourg, 67098

  • Research Site

    Villejuif, 94800

Other trials in France

Germany5 sites

  • Research Site

    Aschaffenburg, 63739

  • Research Site

    Bielefeld, 33604

  • Research Site

    Erlangen, 91052

  • Research Site

    Heilbronn, 74078

  • Research Site

    Warzburg, 97080

Other trials in Germany

Hungary5 sites

  • Research Site

    Budapest, 1085

  • Research Site

    Budapest, 1122

  • Research Site

    Debrecen, 4032

  • Research Site

    Kaposvár, 7400

  • Research Site

    Szolnok, 5004

Other trials in Hungary

Sweden4 sites

  • Research Site

    Gothenburg, 41345

  • Research Site

    Linköping, 58185

  • Research Site

    Lund, SE-22185

  • Research Site

    Örebro, 701 85

Other trials in Sweden

Lithuania3 sites

  • Research Site

    Kaunas, LT-50009

  • Research Site

    Klaipėda, LT-92288

  • Research Site

    Vilnius, LT-08661

Other trials in Lithuania

New Zealand3 sites

  • Research Site

    Auckland, ?0620

  • Research Site

    Otahuhu, 2025

  • Research Site

    Tauranga, 3112

Other trials in New Zealand

Chile2 sites

  • Research Site

    Santiago, 8380455

  • Research Site

    Temuco, 4810469

Other trials in Chile

Colombia2 sites

  • Research Site

    Medellín, 050034

  • Research Site

    Montería, 110221

Other trials in Colombia

About this study

Official title: 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)

Read the 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.

Being tested
Acalabrutinib, Obinutuzumab, Chlorambucil
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcalabrutinibDrug

    Also called ACP-196 (Calquence)

  • ObinutuzumabDrug

    Also called GAZYVA / GAZYVARO

  • ChlorambucilDrug

    Also called LEUKERAN

Study groups in NCT02475681
Study groupRoleWhat they receive
Arm A - Obinutuzumab in Combination with ChlorambucilActive comparatorObinutuzumab 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.
Receives: Drug: Obinutuzumab; Drug: Chlorambucil
Arm B - Acalabrutinib in Combination with ObinutuzumabExperimentalObinutuzumab 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.
Receives: Drug: Acalabrutinib; Drug: Obinutuzumab
Arm C - Acalabrutinib MonotherapyExperimentalAcalabrutinib (ACP-196) will be orally administered on Cycle 1 Day 1 until disease progression or unacceptable toxicity.
Receives: Drug: Acalabrutinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival by IRC (Independent Review Committee) Assessment in Arm A Compared to Arm B

    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.

    Measured: 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 outcomes (4)

  1. Progression-free Survival by IRC Assessment Arm A Versus Arm C

    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.

    Measured: 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.

  2. IRC-assessed Objective Response Rate (ORR) in Arm A Versus Arm B and Arm A Versus Arm C

    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

    Measured: 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.

  3. Time to Next Treatment (TTNT) in Arm A Versus Arm B and Arm A Versus Arm C

    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

    Measured: 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.

  4. Overall Survival (OS) in Arm A Versus Arm B and Arm A Versus Arm C

    OS was defined as the time from the date of randomization to death due to any cause.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2015 (estimated)
  2. Study start26 Jun 2015
  3. Primary completion8 Feb 2019
  4. Study completion15 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
535 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02475681
Sponsor's protocol ID
ACE-CL-007
Other IDs
2023-509348-84-00, 2014-005582-73, 2014, 2023
Acronym
ElevateTN
Status last verified
Aug 2026
First submitted
12 Jun 2015
Last updated
25 Aug 2026
Data monitoring committee
Yes
Individual data sharing
Yes: 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.

Publications

  • Sharman JP, Egyed M, Jurczak W, Skarbnik A, Patel K, Flinn IW, Kamdar M, Munir T, Walewska R, Hughes M, Fogliatto LM, Herishanu Y, Banerji V, Follows G, Walker P, Ghia P, Janssens A, Byrd JC, Ferrant E, Ferrajoli A, Wierda WG, Wachira CW, Suterwala BT, Miranda P, Munugalavadla V, Wun CC, Woyach JA. Acalabrutinib-obinutuzumab improves survival vs chemoimmunotherapy in treatment-naive CLL in the 6-year follow-up of ELEVATE-TN. Blood. 2025 Sep 11;146(11):1276-1285. doi: 10.1182/blood.2024024476.

    PubMed 40198878

  • Kittai AS, Allan JN, James D, Bridge H, Miranda M, Yong ASM, Fam F, Roos J, Shetty V, Skarbnik A, Davids MS. An indirect comparison of acalabrutinib with and without obinutuzumab vs zanubrutinib in treatment-naive CLL. Blood Adv. 2024 Jun 11;8(11):2861-2869. doi: 10.1182/bloodadvances.2023012142.

    PubMed 38598745

  • Sharman JP, Egyed M, Jurczak W, Skarbnik A, Pagel JM, Flinn IW, Kamdar M, Munir T, Walewska R, Corbett G, Fogliatto LM, Herishanu Y, Banerji V, Coutre S, Follows G, Walker P, Karlsson K, Ghia P, Janssens A, Cymbalista F, Woyach JA, Salles G, Wierda WG, Izumi R, Munugalavadla V, Patel P, Wang MH, Wong S, Byrd JC. Acalabrutinib with or without obinutuzumab versus chlorambucil and obinutuzmab for treatment-naive chronic lymphocytic leukaemia (ELEVATE TN): a randomised, controlled, phase 3 trial. Lancet. 2020 Apr 18;395(10232):1278-1291. doi: 10.1016/S0140-6736(20)30262-2.

    PubMed 32305093

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Acalabrutinib, Obinutuzumab and Chlorambucil in people with Chronic Lymphocytic Leukemia, run by Acerta Pharma BV at 155 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 30 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 155 sites in United States, Israel, Italy, Belgium, Poland and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02475681, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.

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