Can a targeted drug boost the power of stem cell transplants for tough lymphoma?
NCT ID NCT07774299
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
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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 28 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2029
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 to 70 years
- 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. 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
Only the study team decides who joins. These are the ways to reach them.
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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.
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