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Phase 2 Study of BGB-16673 and Sonrotoclax for Untreated CLL

This study is testing a new combination of two oral medications, BGB-16673 and BGB-11417 (also called sonrotoclax), for people with chronic lymphocytic leukemia (CLL) who have not yet received treatment. The study aims to see how safe and effective this combination is in treating CLL. Researchers will be looking at how well the treatment reduces the amount of cancer cells in your body and how long you stay free from the disease. You may be able to join if you are 18 or older and have been diagnosed with CLL/SLL that meets specific criteria for treatment.

Study design
This is an open-label, single-arm, phase 2 study planning to enroll 40 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and side effects will be measured through study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07508995

A Phase 2 Trial Of The Bruton Tyrosine Kinase Degrader BGB-16673 In Combination With BCL-2 Inhibitor Sonrotoclax For Patients With Treatment-Naive Chronic Lymphocytic Leukemia (CLL)

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~40 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:BGB-16673BGB-11417

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Adverse Events (AEs)
Measured over Through study completion; an average of 1 year

Conditions

Chronic Lymphocytic Leukemia (CLL)

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Chronic Lymphocytic Leukemia

NCT07508995

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • UT MD Anderson

    Houston, Texasstudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Nitin Jain, MBBS · PRINCIPAL_INVESTIGATOR · UT MD Anderson

Who to contact

Nitin Jain, MBBS
[email protected]
(713) 745-6080
Email the study team

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Eligibility criteria

Inclusion

Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
History of bilateral tubal ligation or another surgical sterilization procedure.
Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Contraception should used for the duration of the study and up to 30 days after completion of BGB-16673 and/or sonrotoclax administration.
Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and up to 30 days after completion of BGB-16673 and/or sonnrotoclax administration. 11. Ability to understand and the willingness to sign a written informed consent document.

What this trial measures

  • Safety and Adverse Events (AEs)Through study completion; an average of 1 year

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0