New triple therapy hopes to tackle tough lymphoma
NCT ID NCT07255963
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a combination of three drugs (pirtobrutinib, lisaftoclax, and rituximab) in adults with diffuse large B-cell lymphoma that has come back or not responded to at least one prior treatment. The goal is to see if this combination can shrink or eliminate tumors. About 29 participants will receive the treatment, and researchers will monitor how many respond 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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 29 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2025
An estimate. Start dates often move.
- Expected to finish
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Sep 2030
An estimate. End dates often move.
- Lead sponsor
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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
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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. ≥18 years old. 2. Capable of understanding and voluntarily signing written informed consent. 3. ECOG performance 0 \~ 3. 4. Anticipated survival ≥3 months 5. Histologically or cytologically confirmed DLBCL. 6. PET-CT-defined measurable disease with a short axis diameter of ≥1.5 cm. 7. Have received at least one prior line of systemic therapy for DLBCL. 8. Resolution of any prior treatment-related non-hematologic toxicities to Grade ≤1 or baseline. 9. Adequate Bone Marrow and Organ Function, defined as: Bone Marrow Function: ANC≥1.5 × 10⁹/L, Platelets ≥80 × 10⁹/L, Hemoglobin ≥80 g/L Hepatic Function: Total bilirubin ≤1.5 × ULN (≤3.0 × ULN if liver metastases present); AST/SGOT and ALT/SGPT ≤2.5 × ULN (≤5.0 × ULN if liver metastases present) Coagulation: INR and aPTT≤1.5 × ULN Renal Function: Serum creatinine ≤1.5 × ULN or estimated creatinine clearance (CrCl) ≥60 mL/min; 10. Subjects with childbearing or childbearing potential must be willing to practice birth control from the date of registration in this study to the follow-up period of the study. 11. Able to swallow tablets/capsules without difficulty. 12. Adhere to scheduled visits, treatment plans, laboratory tests, and other study procedures. Exclusion Criteria: 1. Prior treatment failure or resistance to pirtobrutinib or BCL2 inhibitors. 2. Prior Anticancer Therapy:Chemotherapy, radiotherapy, immunotherapy, or antibody-based anticancer therapy within the specified washout period.Traditional Chinese herbal medicine with antitumor indications.Small-molecule targeted therapy within 2 weeks before study treatment initiation. ADCs or cytotoxic therapy within 10 weeks before study treatment initiation. 3. Participation in another investigational drug study within 4 weeks prior to the first dose of study treatment. 4. Systemic corticosteroid therapy (\>5 days within 14 days prior to treatment) at doses exceeding \>10 mg/day dexamethasone (or equivalent) for CNS disease control. 5. Requiring ongoing anticancer therapy. 6. Uncontrolled or Severe Cardiovascular Disease, 7. Active infection requiring IV antibiotics or systemic antimicrobial therapy. 8. Active HBV/HCV:Exceptions. Inactive HBsAg carriers, HBV patients with sustained viral suppression (HBV-DNA \< LLOD),HCV-cured patients are allowed. 9. Clinically significant abnormalities affecting drug absorption or prior total gastrectomy/gastric banding. 10. History of hemorrhagic diathesis or requirement for long-term oral anticoagulation. 11. Prior allogeneic hematopoietic stem cell transplantation (HSCT) or planned allogeneic HSCT. 12. Women who are pregnant or breastfeeding. 13. Known allergy to the study drug or its excipients. 14. Active psychiatric illness or history of alcohol/drug abuse . 15. Any uncontrolled illness, organ dysfunction, or medical condition that, in the investigator's judgment, jeopardizes patient safety or adherence to study procedures. 16. Other conditions deemed inappropriate for study participation by the investigator.
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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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The First Affiliated Hospital of Soochow University
RECRUITINGSuzhou, Jiangsu, 215006, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a new drug combo reach lymphoma hiding in the brain?
- Can a new drug combo boost remission in aggressive lymphoma?
- Can a new drug shrink Hard-to-Treat lymphoma tumors?
- Can a Four-Pronged attack beat brain lymphoma?
- Can a new drug combo outsmart resistant lymphomas?