Pirtobrutinib Maintenance After CAR-T Therapy in Relapsed or Refractory B-Cell Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University
About this trial
This is a single-arm, open-label, multicenter clinical study to evaluate the efficacy and safety of pirtobrutinib as maintenance therapy in patients with relapsed or refractory B-cell lymphoma after commercial anti-CD19 CAR-T cell therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Able to understand and voluntarily sign the informed consent form.
Age 18 years or older, male or female.
Histologically confirmed large B-cell lymphoma, including diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, or transformed follicular lymphoma (tFL).
Eastern Cooperative Oncology Group performance status of 0 to 2.
Disqualifiers
History of other malignancies, except non-melanoma skin cancer without recurrence for more than 3 years, carcinoma in situ, such as cervical, bladder, or breast carcinoma, or follicular lymphoma.
Prior autologous or allogeneic hematopoietic stem cell transplantation.
Active or suspected uncontrolled fungal, bacterial, viral, or other infection requiring intravenous treatment. Patients with uncomplicated urinary tract infection or uncomplicated bacterial pharyngitis may be enrolled if responding to active treatment.
History of immunodeficiency, including human immunodeficiency virus infection; positive treponema pallidum antibody; active hepatitis B virus infection; or active hepatitis C virus infection.
Trial design
Design model
Single group
Treatments tested in this trial
Pirtobrutinib
DrugPirtobrutinib will be administered orally at a dose of 200 mg once daily for 6 months, beginning on Day 30 after commercial anti-CD19 CAR-T cell infusion. Dose interruption, dose reduction, or treatment discontinuation will be performed according to protocol-specified toxicity management rules.
Second Infusion of Commercial Anti-CD19 CAR-T Cells
Biological/VaccineA second infusion of commercial anti-CD19 CAR-T cells may be administered after completion of 6 months of pirtobrutinib maintenance therapy in selected patients who do not achieve complete response, or who achieve complete response but remain ctDNA-positive, based on investigator assessment and protocol-defined criteria.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Pirtobrutinib Maintenance After CAR-T Cell TherapyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Complete response rate (CRR)
CRR is defined as the proportion of patients who achieve complete response according to the Lugano 2014 criteria at 6 months after initiation of pirtobrutinib maintenance therapy.
Time frame
At 6 months after initiation of pirtobrutinib maintenance therapySecondary outcomes
1
Best complete response rate (bCRR)
bCRR is defined as the proportion of patients whose best response is complete response according to the Lugano 2014 criteria.
Time frame
Up to 24 months2
Best objective response rate (bORR)
bORR is defined as the proportion of patients whose best response is complete response or partial response according to the Lugano 2014 criteria.
Time frame
Up to 24 months3
Objective response rate (ORR)
ORR is defined as the proportion of patients who achieve complete response or partial response according to the Lugano 2014 criteria at 6 months after initiation of pirtobrutinib maintenance therapy.
Time frame
At 6 months after initiation of pirtobrutinib maintenance therapy4
Duration of complete response (DoCR)
DoCR is defined as the time from the first documented complete response to disease progression or death from any cause, whichever occurs first.
Time frame
Up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: