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New treatment option for DLBCL - Diffuse Large B Cell Lymphoma
Official title Pirtobrutinib, Lisaftoclax, and Rituximab in the Treatment of R/R DLBCL
ClinicalTrials.gov ID: NCT07255963
What this study is testing
What is Pirtobrutinib?
Pirtobrutinib is an investigational medicine, being studied as a potential treatment for dlbcl - diffuse large b cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to evaluate the efficacy of combining pirtobrutinib, lisaftoclax, and rituximab (PVR) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have received at least one prior line of systemic therapy and to explore a more effective treatment strategy for this patient population.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥18 years old.
- Capable of understanding and voluntarily signing written informed consent.
- ECOG performance 0 \~ 3.
- Anticipated survival ≥3 months
- Histologically or cytologically confirmed DLBCL.
You likely can't join if
- Prior treatment failure or resistance to pirtobrutinib or BCL2 inhibitors.
- Prior Anticancer Therapy:Chemotherapy, radiotherapy, immunotherapy, or antibody-based anticancer therapy within the specified washout...
- Participation in another investigational drug study within 4 weeks prior to the first dose of study treatment.
- Systemic corticosteroid therapy (\>5 days within 14 days prior to treatment) at doses exceeding \>10 mg/day dexamethasone (or equivalent) for CNS...
- Requiring ongoing anticancer therapy.
- Uncontrolled or Severe Cardiovascular Disease,
See the full eligibility criteria
- ≥18 years old.
- Capable of understanding and voluntarily signing written informed consent.
- ECOG performance 0 \~ 3.
- Anticipated survival ≥3 months
- Histologically or cytologically confirmed DLBCL.
- PET-CT-defined measurable disease with a short axis diameter of ≥1.5 cm.
- Have received at least one prior line of systemic therapy for DLBCL.
- Resolution of any prior treatment-related non-hematologic toxicities to Grade ≤1 or baseline.
- 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...
- people 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.
- Able to swallow tablets/capsules without difficulty.
- Adhere to scheduled visits, treatment plans, laboratory tests, and other study procedures.
- Prior treatment failure or resistance to pirtobrutinib or BCL2 inhibitors.
- 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...
- Participation in another investigational drug study within 4 weeks prior to the first dose of study treatment.
- Systemic corticosteroid therapy (\>5 days within 14 days prior to treatment) at doses exceeding \>10 mg/day dexamethasone (or equivalent) for CNS disease control.
- Requiring ongoing anticancer therapy.
- Uncontrolled or Severe Cardiovascular Disease,
- Active infection requiring IV antibiotics or systemic antimicrobial therapy.
- Active HBV/HCV:Exceptions. Inactive HBsAg carriers, HBV patients with sustained viral suppression (HBV-DNA \< LLOD),HCV-cured patients are allowed.
- Clinically significant abnormalities affecting drug absorption or prior total gastrectomy/gastric banding.
- History of hemorrhagic diathesis or requirement for long-term oral anticoagulation.
- Prior allogeneic hematopoietic stem cell transplantation (HSCT) or planned allogeneic HSCT.
- Women who are pregnant or breastfeeding.
- Known allergy to the study drug or its excipients.
- Active psychiatric illness or history of alcohol/drug abuse .
- Any uncontrolled illness, organ dysfunction, or medical condition that, in the investigator's judgment, jeopardizes patient safety or adherence to study procedures.
- Other conditions deemed inappropriate for study participation by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhou, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.