NCT07831395Not yet recruitingPhase 2
Rituximab, Pirtobrutinib, Lisaftoclax and Liposomal Mitoxantrone for for Richter Syndrome Transformed From CLL
Single-Arm, Multicenter, Prospective Phase II Clinical Study of Rituximab Combined With Pirtobrutinib, Lisaftoclax and Liposomal Mitoxantrone for Richter Syndrome Transformed From Chronic Lymphocytic Leukemia
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
This single-arm, multicenter, open-label phase II trial evaluates the efficacy and safety of rituximab + pirtobrutinib + lisaftoclax + liposomal mitoxantrone in adults with CLL-transformed Richter syndrome (CLL-RS). All eligible patients receive 4 cycles (21 days each) of the quadruple regimen: rituximab 375 mg/m² IV on Day 0, pirtobrutinib 200 mg PO daily (D1-21), lisaftoclax ramp-up to 600 mg QD (D1-21), and liposomal mitoxantrone 18 mg/m² IV on D1, with TLS prophylaxis/monitoring. Primary endpoint: CR rate after 4 cycles. Secondary endpoints: ORR, DOR, PFS, OS, MRD negativity, and safety. Post-induction: CR/PR patients proceed to allo-HSCT, CAR-T, or maintenance; SD/PD receive alternative/palliative care. Long-term follow-up starts after discontinuation.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 23 (estimated)
- First submitted
- 12 Aug 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Diseases
- Chronic lymphocytic leukaemia
- NCT number
- NCT07831395
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 23
- From 1 Sept 2026 to the primary completion date, 31 Dec 2030
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with pirtobrutinib or lisaftoclax.
- Prior chimeric antigen receptor T-cell (CAR-T) therapy or allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- Requirement for concurrent warfarin or other vitamin K antagonist anticoagulation; concurrent treatment with strong CYP3A4/5 inhibitors.
Other illness
- Uncontrolled active infection requiring intravenous antibiotic therapy.
- Severe cardiopulmonary disease: uncontrolled hypertension (systolic BP ≥ 180 mmHg or diastolic BP ≥ 110 mmHg), unstable angina, myocardial infarction or cerebral infarction within the past 6 months.
- Medical history of stroke, intracranial hemorrhage, or other severe bleeding events.
- Severe hepatic or renal impairment failing to meet the organ function thresholds listed in inclusion criteria.
- Known hypersensitivity to any component of the study regimen.
- Psychiatric disorder or cognitive impairment precluding adherence to study procedures.
- Any other condition deemed inappropriate for trial participation by the investigator (e.g., substance abuse, unresolved legal issues).
Other
- RS transformation to histologic subtypes other than DLBCL (e.g., Hodgkin lymphoma, Burkitt lymphoma).
- Non-CLL clonal DLBCL transformation confirmed via Immunoglobulin Heavy Chain Variable (IgHV) sequencing analysis.
- Central Nervous System (CNS) lymphoma involvement (lymphoma cells detected in cerebrospinal fluid or intracranial lesions identified on brain MRI/CT).
- Pregnant or breastfeeding female patients.
Who the study is looking for
- Age ≥ 18 years, any gender.
- Histopathologically confirmed clonally related Chronic Lymphocytic Leukemia (CLL)-derived Richter Syndrome (RS) with diffuse large B-cell lymphoma (DLBCL) transformation.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2.
- Estimated survival ≥ 3 months.
- Adequate organ function as defined below:
- Hematologic: Absolute Neutrophil Count (ANC) ≥ 1.0 × 10⁹/L; Platelet (PLT) ≥ 30 × 10⁹/L. Cytopenias secondary to CLL bone marrow infiltration are acceptable.
- Hepatic: Total bilirubin ≤ 2.0 × Upper Limit of Normal (ULN); ≤ 3.0 × ULN for patients with CLL liver involvement or Gilbert syndrome. Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) ≤ 2.5 × ULN; ≤ 5.0 × ULN for patients with CLL liver infiltration.
- Renal: estimated Glomerular Filtration Rate (eGFR) ≥ 50 mL/min.
- Voluntarily provides written informed consent prior to any study-related procedures.
- Able to take oral study medications, communicate with investigators, and complete all scheduled study assessments and follow-up visits.
- Willing and able to comply with all protocol-specified restrictions and prohibitions.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The First Affiliated Hospital of NanChang University Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Jiangsu Province Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.