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Four drugs aimed at a leukemia that turns aggressive

NCT ID NCT07831395

NEW Disease control Sponsor: Institute of Hematology & Blood Diseases Hospital, China Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are testing whether a combination of rituximab, pirtobrutinib, lisaftoclax and liposomal mitoxantrone can shrink tumors in adults whose chronic lymphocytic leukemia has transformed into the aggressive cancer Richter syndrome. The trial plans to enroll 23 adults who will receive four 21-day cycles of the regimen, with close monitoring for tumor lysis syndrome. The main goal is to see how many participants achieve a complete response after four cycles, and researchers will also track overall response, survival and safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a four-drug combination of rituximab, pirtobrutinib, lisaftoclax and liposomal mitoxantrone
What this could lead to
If the regimen works, it could offer a stronger first treatment for people whose chronic lymphocytic leukemia has turned into the aggressive Richter syndrome, possibly helping more of them reach a remission deep enough for a stem cell transplant or CAR-T therapy.
What could go wrong
This is a small phase 2 trial with 23 planned participants and no comparison group, so any benefit seen may not hold up in larger studies. The four drugs can cause serious side effects, including tumor lysis syndrome, infusion reactions and low blood counts.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 23 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Inclusion Criteria 1. Age ≥ 18 years, any gender. 2. Histopathologically confirmed clonally related Chronic Lymphocytic Leukemia (CLL)-derived Richter Syndrome (RS) with diffuse large B-cell lymphoma (DLBCL) transformation. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2. 4. Estimated survival ≥ 3 months. 5. Adequate organ function as defined below: 1. Hematologic: Absolute Neutrophil Count (ANC) ≥ 1.0 × 10⁹/L; Platelet (PLT) ≥ 30 × 10⁹/L. Cytopenias secondary to CLL bone marrow infiltration are acceptable. 2. 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. 3. Renal: estimated Glomerular Filtration Rate (eGFR) ≥ 50 mL/min. 6. Voluntarily provides written informed consent prior to any study-related procedures. 7. Able to take oral study medications, communicate with investigators, and complete all scheduled study assessments and follow-up visits. 8. Willing and able to comply with all protocol-specified restrictions and prohibitions. Exclusion Criteria: 1. RS transformation to histologic subtypes other than DLBCL (e.g., Hodgkin lymphoma, Burkitt lymphoma). 2. Non-CLL clonal DLBCL transformation confirmed via Immunoglobulin Heavy Chain Variable (IgHV) sequencing analysis. 3. Central Nervous System (CNS) lymphoma involvement (lymphoma cells detected in cerebrospinal fluid or intracranial lesions identified on brain MRI/CT). 4. Prior treatment with pirtobrutinib or lisaftoclax. 5. Prior chimeric antigen receptor T-cell (CAR-T) therapy or allogeneic hematopoietic stem cell transplantation (allo-HSCT). 6. Uncontrolled active infection requiring intravenous antibiotic therapy. 7. 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. 8. Requirement for concurrent warfarin or other vitamin K antagonist anticoagulation; concurrent treatment with strong CYP3A4/5 inhibitors. 9. Medical history of stroke, intracranial hemorrhage, or other severe bleeding events. 10. Severe hepatic or renal impairment failing to meet the organ function thresholds listed in inclusion criteria. 11. Known hypersensitivity to any component of the study regimen. 12. Pregnant or breastfeeding female patients. 13. Psychiatric disorder or cognitive impairment precluding adherence to study procedures. 14. Any other condition deemed inappropriate for trial participation by the investigator (e.g., substance abuse, unresolved legal issues).

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Conditions

The condition(s) this trial relates to.

Richter transformation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Richter syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008, China

  • Jiangsu Province Hospital

    Nanjing, China

  • Nanfang Hospital Southern Medical University

    Guangzhou, China

  • The First affiliated hospital of Nanchang University

    Nanchang, Jiangxi, 330006, China

  • The second Xiangya hospital of central south university

    Changsha, Hunan, 410012, China

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, China

More trials for these conditions

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