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Chronic Lymphocytic Leukemia (CLL)Phase 2NCT04447768

The Combination of Venetoclax and Obinutuzumab in People With Chronic Lymphocytic Leukemia (CLL)

A Phase 2 study testing Obinutuzumab and Venetoclax in people with Chronic Lymphocytic Leukemia (CLL), 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 help researchers collect more information about how effective the combination of venetoclax and obinutuzumab is in treating CLL in people who have not received a previous treatment for their cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia (CLL)
What is being tested?
Obinutuzumab and Venetoclax
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
8 sitesUnited States
Study dates
3 Dec 2020to Jul 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.
  • Ability and willingness to comply with the requirements of the study protocol.
  • Age ≥18 years.
  • Have documented previously untreated chronic lymphocytic leukemia according to iwCLL / WHO criteria.
  • Require treatment of CLL per iwCLL guidelines.
  • CIRS score ≤ 6 (patient's CLL diagnosis is not included in CIRS score).
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  • Eastern Cooperative Oncology Group Performance Status of 0 or 1.
  • Adequate hematologic function (unless caused by underlying disease, as established by extensive bone marrow involvement or as a result of hypersplenism secondary to the involvement of the spleen by CLL per the investigator) defined as follows:
  • Hemoglobin ≥ 8 g/dL without transfusion support, unless anemia is due to marrow involvement of CLL.
  • Absolute neutrophil count ≥ 1.0 x 10^9/L.
  • Platelet count ≥ 30 x 10^9/L; in cases of thrombocytopenia clearly due to marrow involvement of CLL (per the discretion of the investigator), platelet count should be ≥ 10 x 10^9/L if there is bone marrow involvement.
  • Adequate renal function, as indicated by modified Cockcroft-Gault equation (eCCR; with the use of ideal body mass [IBM] instead of mass) of > 50mL/min
  • Adequate liver function, as indicated by:
  • AST or ALT ≤ 2.5 x ULN.
  • Total bilirubin ≤ 1.5 x ULN (or ≤ 5 x ULN for patients with documented Gilbert syndrome).
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 30 days after the last dose of venetoclax or 18 months after the last dose of obinutuzumab, whichever is longer.
  • Women must refrain from donating eggs during this same period.
  • A woman is considered to be 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.
  • 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 postovulation methods) and withdrawal are not acceptable methods of contraception.
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:
  • 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 90 days after the last dose of venetoclax or 18 months after the last dose of obinutuzumab, whichever is longer. Men must refrain from donating sperm during this same period.
  • With pregnant female partners, men must remain abstinent or use a condom for the duration of the pregnancy 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 postovulation methods) and withdrawal are not acceptable methods of contraception.

Who cannot join

  • Prior CLL-directed therapy. Patients may have received a brief (≤7 days) course of systemic steroids prior to initiation of study therapy for control of lymphoma-related symptoms.
  • Transformation of CLL to aggressive NHL (Richter's transformation or prolymphocytic leukemia).
  • Known hypersensitivity to any of the study drugs.
  • History of prior malignancy, except for conditions as listed below if patients have recovered from the acute side effects incurred as a result of previous therapy:
  • Malignancies treated with curative intent and with no known active disease within 2 years
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease (no time constraint).
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  • Adequately treated cervical carcinoma in situ without evidence of disease (no time constraint).
  • Surgically/adequately treated low grade, early stage, localized prostate cancer without evidence of disease (no time constraint).
  • 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 4 weeks prior to Cycle 1 Day 1.
  • Requires the use of warfarin (because of potential drug-drug interactions that may potentially increase the exposure of warfarin).
  • Received the following agents within 7 days prior to the first dose of venetoclax:
  • Strong and moderate CYP3A inhibitors.
  • Strong and moderate CYP3A inducers.
  • Consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges), or star fruit within 3 days prior to the first dose of venetoclax.
  • Clinically significant history of liver disease, including active viral or other hepatitis, current alcohol abuse, or cirrhosis
  • Presence of positive test results for hepatitis B virus (HBV), hepatitis B surface antigen (HBsAg), or hepatitis C (HCV) antibody
  • 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. These patients must be willing to undergo monthly DNA testing and should consider antiviral prophylaxis as per institutional standards.
  • Known infection with HIV or human T-cell leukemia virus 1 (HTLV-1)
  • Receipt of live-virus vaccines within 28 days prior to the initiation of study treatment or need for live-virus vaccines at any time during study treatment
  • Pregnant or lactating, or intending to become pregnant during the study
  • °Women of childbearing potential must have a negative serum pregnancy test result within 21 days prior to initiation of study drug per institutional standards.
  • Recent major surgery (within 4 weeks prior to the start of Cycle 1, Day 1) other than for diagnosis.
  • Inability to swallow a large number of tablets.
  • Malabsorption syndrome or other condition that precludes enteral route of administration. This is subject to investigator discretion.
  • Known allergy to both xanthine oxidase inhibitors and rasburicase.

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

  • University of North Carolina

    Chapel Hill, North Carolina, 27514

  • Memorial Sloan Kettering Commack (All protocol activities)

    Commack, New York, 11725

  • 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 Cancer Center (All Protocol Activities)

    New York, New York, 10065

  • Stanford University Medical Center (Data collection only)

    Stanford, California, 94305-5408

  • Memorial Sloan Kettering Nassau (All protocol activities)

    Uniondale, New York, 11553

Other trials in United States

About this study

Official title: A Phase II: Venetoclax-Based Therapy for the Treatment of Fit Patients With Chronic Lymphocytic Leukemia (CLL) in the Front-Line Setting

This study will help researchers collect more information about how effective the combination of venetoclax and obinutuzumab is in treating CLL in people who have not received a previous treatment for their cancer.

Keywords
Venetoclax, Obinutuzumab, 20-044
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.

  • ObinutuzumabDrug

    Cycle 1, Day 1- 100 mg

    Cycle 1, Day 2 - 900 mg

    Cycle 1, Day 8 - 1000 mg

    Cycle 1, Day 15 -1000 mg

    Cycle 2, Day 1 to Cycle 6, Day 1- 1000 mg

  • VenetoclaxDrug

    Cycle 1, Day 22 to 28 -20 mg daily

    Cycle 2, Day 1 to Day 7 -50 mg daily

    Cycle 2, Day 8 to Day 14- 100 mg daily

    Cycle 2, Day 15 to Day 21- 200 mg daily

    Cycle 2, Day 22 to Day 28 - 400 mg daily

    Cycle 3, Day 1 to end of Cycle 12-24 - 400 mg daily

Study groups in NCT04447768
Study groupRoleWhat they receive
Venetoclax and ObinutuzumabExperimentalAll patients will receive a minimum of 9 cycles (cycle = 28 days) of therapy with venetoclax and obinutuzumab during the treatment period. For patients who remain MRD positive at Cycle 9 of therapy, an additional 12 cycles of venetoclax monotherapy will be given.
Receives: Drug: Obinutuzumab; Drug: Venetoclax

What is being measured

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

  1. progression-free survival (PFS)

    Measured: 36 months

Secondary outcomes (1)

  1. Overall response rate

    Overall response rate (ORR) is defined as the proportion of patients with a best overall response of partial response (PR) or complete response (CR). Patients who do not have a tumor response assessment for any reason will be considered non-responders and will be included in the denominator when calculating the ORR.

    Measured: 2 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 Jun 2020
  2. Study start3 Dec 2020
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 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
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04447768
Sponsor's protocol ID
20-044
Status last verified
Jul 2026
First submitted
24 Jun 2020
Last updated
7 Jul 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 Obinutuzumab and Venetoclax in people with Chronic Lymphocytic Leukemia (CLL), 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 24 inclusion and 26 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 7 Jul 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 NCT04447768.

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 7 Jul 2026.

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