Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Promising combo targets CLL in untreated patients

NCT ID NCT04447768

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times

Summary

This study is testing a combination of two drugs, venetoclax and obinutuzumab, in people with chronic lymphocytic leukemia (CLL) who have not yet had treatment. The goal is to see how well this therapy controls the disease and improves survival. About 100 fit adults with CLL will take part, and researchers will monitor their response and any side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

100 people

The number who actually took part.

Started

Dec 2020

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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). * 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. Exclusion Criteria: * 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). * 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Chronic lymphocytic leukemia (CLL) are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Memorial Sloan Kettering Basking Ridge (All protocol activities)

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Commack (All protocol activities)

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth (All protocol activities)

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau (All protocol activities)

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Westchester (All protocol activities)

    Harrison, New York, 10604, United States

  • Stanford University Medical Center (Data collection only)

    Stanford, California, 94305-5408, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27514, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.