New combo pill attack aims to control blood cancers
NCT ID NCT07609862
First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times
Summary
This study tests two experimental drugs (rocbrutinib and lacutoclax) taken together to treat several types of blood cancers, including lymphoma and leukemia. The goal is to see if the combination is safe and can shrink or control the cancer. About 92 adults who have already tried other treatments will take part. This is not a cure; patients may need ongoing therapy.
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 92 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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May 2033
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: 1. Age ≥18 years, regardless of sex. 2. Ib: Histologically confirmed diagnosis of CLL/SLL (per 2018 iwCLL criteria) or B-cell malignancies (per 2022 WHO classification), including: MCL, DLBCL, FL, and WM. Must have received at least one prior line of systemic therapy, with documented disease progression or intolerance. II: For Treatment-naïve (TN) CLL/SLL patients: Must meet iwCLL treatment indications and no prior systemic therapy. For R/R CLL/SLL patients: at least one prior systemic therapy with documented disease progression or intolerance. 3. Have at least one measurable lesion. 4. Phase Ib: ECOG performance status ≤1; phase II: ECOG performance status ≤2. 5. Life expectancy ≥ 12 weeks. 6. Adequate coagulation function, liver and kidney function, bone marrow hematopoietic function. 7. Male patients and female patients of childbearing potential must agree to use effective contraception during the study and for 90 days after the last dose of study treatment. Female patients of childbearing potential must have a negative pregnancy test before study treatment and must not be breastfeeding. Male patients must not donate sperm during the study and for 90 days after the last dose. 8. Participation is voluntary, requiring signed informed consent and compliance with the treatment regimen and visit schedule. Exclusion Criteria: 1. Known hypersensitivity or intolerance to Rocbrutinib, Lacutoclax, or any of their excipients; prior treatment with any BCL-2 inhibitor; or prior treatment with both covalent and non-covalent BTK inhibitors. 2. Use of systemic corticosteroids at doses equivalent to \>20 mg/day of prednisone for ≥3 days within 7 days prior to the first dose. 3. History of or currently suspected Richter's syndrome. 4. Known or suspected central nervous system (CNS) involvement. 5. Prior allogeneic hematopoietic stem cell transplantation (allo-HSCT), or autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptor T-cell (CAR-T) therapy within 90 days before the first dose of study treatment. 6. Received antitumor therapy, investigational agents, major surgery, severe trauma, or live attenuated vaccines within 4 weeks or 5 half-lives prior to the first dose of study treatment. 7. Received herbal medicines for antitumor treatment, or localized radiotherapy within 14 days prior to the first dose of study treatment. 8. Use of moderate or strong CYP3A inhibitors within 7 days prior to the first dose of study treatment, or consumption of grapefruit, grapefruit juice, starfruit, or Seville oranges within 3 days prior to prior to the first dose. 9. History of other active malignancies within the past 3 years, except for curatively treated basal cell carcinoma, localized squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or other malignancies considered cured. 10. Any severe and/or uncontrolled systemic disease, or any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the study. 11. Any of the following events within 6 months prior to the first dose: Symptomatic arrhythmia, myocardial infarction, intracranial hemorrhage, or Stroke. 12. Impaired cardiac function. 13. Any uncontrolled systemic infection. 14. Conditions that may impair oral drug administration or significantly affect absorption or pharmacokinetics of the study drug. 15. Unable to discontinue moderate or strong CYP3A inhibitors or inducers, P-gp (P-glycoprotein) inhibitors, sensitive substrates of OATP1B3 or CYP2C8 during the study period. 16. Received vaccination with any live-attenuated vaccines within 4 weeks prior to the first dose of study treatment. 17. Evidence of an active bleeding constitution or a history of significant hemorrhagic disorders. 18. Requirement for ongoing therapy with warfarin or other vitamin K antagonists. 19. Presence of an active, uncontrolled, or symptomatic autoimmune disease that requires systemic treatment. 20. Any other condition that, in the investigator's judgment, makes the patient unsuitable for study participation.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
RECRUITINGTianjin, China
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Other studies related to the condition(s) this trial covers.
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- Can a 'Universal' cancer target outsmart resistant blood cancers?