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Can a targeted drug boost the power of stem cell transplants for tough lymphoma?

NCT ID NCT07774299

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This phase 2 trial is testing whether adding the targeted drug pirtobrutinib to a standard chemotherapy conditioning regimen (BEAM) before an autologous stem cell transplant can improve outcomes for people with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The study will enroll about 28 adults aged 18-70 who have achieved a partial or complete response after second-line or later therapy. The main goal is to see how long participants live without their disease progressing after the transplant, with secondary goals including overall survival, complete remission rates, and how quickly blood cells recover.

What this could mean

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

Active substance
pirtobrutinib combined with BEAM (carmustine, etoposide, cytarabine, melphalan)
What this could lead to
If successful, this combination could improve the effectiveness of stem cell transplants for people with hard-to-treat DLBCL, potentially leading to longer remission.
What could go wrong
This is a small, early-phase study, so results may not apply broadly. The intensive chemotherapy carries risks like infection and organ damage, and the added benefit of pirtobrutinib is not yet proven.

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 28 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2029

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 to 70 years

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: 1. According to world Health Organization (WHO) classification of disease, diffuse large B-cell lymphoma was confirmed by histology, CR or PR after second-line and above treatment; 2. 18≤ age ≤70 years old, male or female; 3. ECOG score 0-2; 4. No serious organic lesions in the main organs, meeting the requirements of the following laboratory examination indicators (conducted within 7 days before treatment) : 1. White blood cell count ≥3.0×109/L, absolute neutrophil count ≥1.5×109/L, Hemoglobin ≥90g/L, platelet ≥75×109/L; 2. Total bilirubin ≤1.5× upper normal value (ULN); 3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5× ULN; Bilirubin ≤1.5× ULN 4. Creatinine clearance was 44-133 mmol/L; 5. No cardiac dysfunction; 6. Life expectancy over 3 months; 7. The subject or his/her legal representative must provide written informed consent prior to conducting a special study examination or procedure. Exclusion Criteria: 1. Previously received autologous hematopoietic stem cell transplantation; 2. Suffering from serious complications or severe infection; 3. Central nervous system lymphoma was excluded; 4. A history of other malignant tumors within 5 years, excluding early tumors treated for curative purposes; 5. Patients with uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases, etc.; 6. HBsAg, HCV or HIV positive. Positive HBV and HCV serology is allowed, but DNA/RNA testing must be negative; 7. Left ventricular ejection fraction ≦ 50%; 8. Laboratory test value during screening; ① Neutrophils \<1.5×109/L; Platelet \<75×109/L; ② Bilirubin was 1.5 times higher than the normal upper limit, transaminase was 2.5 times higher than the normal upper limit; ③ The creatinine level is higher than 1.5 times the upper limit of normal value; 9. Other concurrent and uncontrolled medical conditions considered by the investigator would affect the patient's participation in the study; 10. Psychiatric patients or other patients known or suspected to be unable to fully comply with the study protocol; 11. Pregnant or lactating women; 12. The researcher judged that the patients were not suitable for this study.

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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

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  1. 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 ↗

  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.