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Chronic Lymphocytic LeukemiaPhase 2NCT04722172

A Study on Limiting Treatment Time With Acalabrutinib Combined With Obinutuzumab in People With CLL or SLL

A Phase 2 study testing Acalabrutinib and Obinutuzumab in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.

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 study will test the safety of limiting treatment time with acalabrutinib and obinutuzumab in people who have chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Acalabrutinib and Obinutuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
8 sitesUnited States
Study dates
21 May 2021to Feb 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Signed informed consent form (ICF). Legally Authorized Representatives are permitted.
  • Ability and willingness to comply with requirements of the study protocol
  • ≥ 18 years-old
  • Have documented previously untreated CLL or SLL per WHO criteria and require treatment per iwCLL guidelines
  • ECOG performance status of 0, 1, or 2, with no deterioration over the previous 2 weeks prior to baseline or day of first dosing
  • Participants must have adequate organ and marrow function as defined below:
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  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN), unless there is a disease involvement of the liver, hemolysis, or a known history of Gilbert's disease.
  • Hemoglobin ≥ 8 g/dL without transfusion support, unless anemia is due to marrow involvement of CLL.
  • Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L.
  • AST and ALT ≤ 2.5 times the ULN.
  • Creatinine clearance (CrCl) > 30 mL/min as calculated using modified Cockcroft- Gault or MDRD Formula
  • PT/INR ≤ 2 times the ULN and aPTT ≤ 2 times the ULN unless the elevation in PT/INR or aPTT is solely attributable to direct oral anticoagulant.
  • Platelet count without transfusion support must be ≥ 50,000 cells/mm3 or ≥ 30,000 cells/mm^3 in subjects with documented bone marrow involvement, as determined locally.
  • For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method (failure rate of < 1%) per year during the treatment period and for at least 18 months after the last dose of study medication. Women of childbearing potential must have a negative serum pregnancy test result within 3 days prior to initiation of study drug
  • Women must refrain from donating eggs during this same period
  • A woman is considered of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus)
  • Examples of contraceptive methods with a failure rate of < 1 % per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices
  • Examples of contraceptive methods with a failure rate of < 1 % per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices
  • With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period and for at least 6 months after- the last dose of obinutuzumab; men must refrain from donating sperm during this same period
  • With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 6 months after the last dose of obinutuzumab to avoid exposing the embryo
  • The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception

Who cannot join

  • Prior CLL-directed therapy
  • °Excluding corticosteroid therapy started for non-CLL related reasons or brief courses for disease related symptom management
  • Received any investigational drug within 30 days or 5 half-lives (whichever is shorter) before first dose of study drug
  • History of prior malignancy that could affect compliance with the protocol or interpretation of results, except for the following:
  • Curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or carcinoma in situ of the prostate at any time prior to study.
  • Other cancers not specified above that have been curatively treated by surgery and/or radiation therapy from which subject is disease-free for ≥3 years without further treatment.
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  • Transformation of CLL to aggressive lymphoma (Richter's transformation to NHL or Hodgkin's lymphoma, or pro-lymphocytic leukemia)
  • CLL with deletion of chromosome 17p and/or TP53 mutation. Patients must have FISH or array CGH analysis and NGS for TP53 mutations locally as per SOC within 60 days of C1D1 (peripheral blood, bone marrow or lymph node with disease involvement are acceptable sources) as SOC.
  • History of or ongoing confirmed central nervous system (CNS) lymphoma.
  • Known hypersensitivity to any active ingredient in the study drugs.
  • Active bleeding, or presence of known bleeding disorder (e.g. von Willebrand's disease) or hemophilia.
  • Any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
  • Clinically significant cardiac disease that includes symptomatic arrhythmia (subjects with controlled, asymptomatic atrial fibrillation or other atrial arrhythmias during screening are allowed to enroll on study)
  • Intracranial hemorrhage, stroke within 6 months of study enrollment
  • Symptomatic, or history of documented congestive heart failure (NY Heart Symptomatic, or history of documented congestive heart failure (NY Heart Association functional classification III-IV
  • Myocardial infarction within 6 months of enrollment
  • Concomitant use of medication known to cause QT prolongation or torsade's de pointes should be used with caution and at investigator's discretion
  • Angina not well-controlled by medication
  • Poorly controlled or clinically significant atherosclerotic vascular disease including cerebrovascular accident (CVA), transient ischemic attack (TIA), angioplasty, cardiac/vascular stenting within 6 months of study enrollment
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 2 weeks prior to cycle 1 day 1 including subjects with positive cytomegalovirus [CMV] DNA polymerase chain reaction [PCR].
  • Requires the use of warfarin or equivalent Vitamin K antagonist
  • Requires or received the following agents within 7 days prior to the first dose of acalabrutinib-obinutuzumab combination therapy:
  • Patients who are positive for HCV antibody must be negative for HCV by polymerase chain reaction (PCR) to be eligible for study participation
  • Patients with occult or prior HBV infection (defined as positive total hepatitis B core antibody [HBcAb] and negative HBsAg) may be included if HBV DNA is undetectable by PCR. These patients must be willing to undergo sequential DNA testing as per institutional standards (every 1-3 months) and antiviral prophylaxis as per institutional standards.
  • Uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenic purpura).
  • Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening, this is subject to investigator's discretion
  • Known infection with HIV (testing not required as part of screening)
  • Receipt of live-virus vaccines within 28 days prior to the initiation of study treatment
  • Pregnant or lactating, or intending to become pregnant during the study
  • Major surgical procedures within 28 days of first dose of study drug. Note: if a subject had major surgery, they must have recovered adequately from any toxicity and/or complications from the intervention before the first dose of study drug.
  • Malabsorption syndrome or other condition that precludes enteral route of administration; this is subject to investigator discretion
  • Has difficulty with or is unable to swallow oral medication
  • Concurrent participation in the treatment phase of an interventional clinical trial
  • Unwilling or unable to participate in all required study evaluations and procedures. Unable to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local patient privacy regulations).

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Memorial Sloan Kettering Basking Ridge (All protocol activities)

    Basking Ridge, New Jersey, 07920

  • Memorial Sloan Kettering Commack (All protocol activities)

    Commack, New York, 11725

  • Hackensack Meridian Health (Data collection only)

    Hackensack, New Jersey, 07601

  • Memorial Sloan Kettering Westchester (All protocol activities)

    Harrison, New York, 10604

  • Memorial Sloan Kettering Monmouth (All protocol activities)

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Bergen (All protocol activities)

    Montvale, New Jersey, 07645

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York, 10065

  • Memorial Sloan Kettering Nassau (All protocol activities)

    Uniondale, New York, 11553

Other trials in United States

About this study

Official title: A Phase 2 Time Limited Approach Based on Depth of Response to Front-Line Acalabrutinib in Combination With Obinutuzumab for CLL/SLL Patients Who Achieve Complete Remission or Partial Remission With Undetectable Minimal Residual Disease

This study will test the safety of limiting treatment time with acalabrutinib and obinutuzumab in people who have chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The researchers want to find out whether stopping the study drugs when the cancer responds to the treatment, followed by a period of observation in which no treatment is given, is better than, the same as, or worse than the usual approach. A usual treatment for CLL and SLL is to give the study drugs continuously until the cancer progresses, even if the disease is in remission. But when people receive these drugs for long periods of time, they can have serious side effects and their cancer can become resistant to treatment.

Being tested
Acalabrutinib, Obinutuzumab
Keywords
Acalabrutinib, Obinutuzumab, 20-503
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

    Acalabrutinib for a minimum of 13 cycles and maximum 26 cycles.

  • ObinutuzumabDrug

    Obinutuzumab will be administered during Cycles 2-7.

Study groups in NCT04722172
Study groupRoleWhat they receive
Acalabrutinib Combined With ObinutuzumabExperimentalPatients will receive acalabrutinib for a minimum of 13 cycles and maximum 26 cycles and Obinutuzumab will be administered during Cycles 2-7. This will be followed by treatment-free observation through the 65th cycle. Patients who progress during the observation period, per iwCLL criteria, will receive 13 cycles of acalabrutinib in combination with obinutuzumab in the retreatment phase of this study.
Receives: Drug: Acalabrutinib; Drug: Obinutuzumab

What is being measured

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

  1. progression-free survival (PFS)

    Progression free survival (PFS) will be measured from the time the patient initiates treatment, until documented progression of disease, relapse, or death due to any cause, whichever comes first.

    Measured: 36 months

Secondary outcomes (1)

  1. Adverse events from Acalabrutinib with Obinutuzumab

    Definitions found in the Common Terminology Criteria for Adverse Events version 5 (CTCAE v 5.0) will be used for grading the severity (intensity) of adverse events.

    Measured: 3 years

Timeline

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

  1. First posted25 Jan 2021
  2. Study start21 May 2021
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a phase II, multicenter clinical trial.
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04722172
Sponsor's protocol ID
20-503
Status last verified
Jun 2026
First submitted
20 Jan 2021
Last updated
4 Jun 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Acalabrutinib and Obinutuzumab in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.

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 21 inclusion and 34 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 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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 (PFS) (time frame: 36 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 NCT04722172.

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 4 Jun 2026.

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