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New treatment option for Pirtobrutinib
Official title Thiotepa in Combination With Pirtobrutinib (a BTK Inhibitor) and Sintilimab (a PD-1 Inhibitor) for Frail or Relapsed/Refractory Primary or Secondary Central Nervous System Lymphoma
ClinicalTrials.gov ID: NCT07416890
What this study is testing
What is Thiotepa, Pirtobrutinib , Sintilimab(TPS)?
Thiotepa, Pirtobrutinib , Sintilimab(TPS) is an investigational medicine, being studied as a potential treatment for pirtobrutinib.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a prospective, single-Arm, phase II clinical study evaluating the efficacy and safety of thiotepa in combination with pirtobrutinib (a BTK Inhibitor) and sintilimab (a PD-1 Inhibitor) for frail or relapsed/refractory primary or secondary central nervous system lymphoma.It includes screening phase， induction therapy phase, and maintenance therapy phase.The screening period is defined as within 14 days prior to the first dose.Induction Treatment Phase: Enrolled subjects will receive a combination regimen of thiotepa, pirtobrutinib, and sintilimab. Treatment is administered in 21-day cycles for up to 6 cycles.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 1 year
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Histopathologically confirmed relapsed primary central nervous system lymphoma (PCNSL) of B-cell lineage, or secondary central nervous system...
- The patients or their legal guardians provide voluntary written informed consent.
- Age\>=18 years, both male and female.
- Karnofsky Performance Status (KPS) score\>=40.
- Patients deemed unsuitable for methotrexate (MTX)-based systemic chemotherapy ("unfit"), including but not limited to: patients assessed as...
You likely can't join if
- The patients with secondary central nervous system lymphoma (SCNSL) who have lesions outside the CNS and require systemic treatment.
- Received chemotherapy, radiotherapy, immunotherapy or antibody-based treatments for anti-tumor purposes within 4 weeks prior to the first...
- Receipt of any vaccine (including but not limited to vaccines for COVID-19, influenza, pneumonia, shingles, hepatitis B, etc.) within 4 weeks before...
- Concurrent enrollment in another treatment clinical study, or less than 4 weeks between the last dose of prior clinical trial treatment and the first...
- Previous treatment with thiotepa, PD-1 inhibitors, or BTK inhibitors is not excluded by default but requires benefit-risk assessment by the...
- History of active bleeding within 4 weeks before the first dose; need for therapeutic anticoagulation during the study (e.g., warfarin or vitamin K...
See the full eligibility criteria
Who can join
- Histopathologically confirmed relapsed primary central nervous system lymphoma (PCNSL) of B-cell lineage, or secondary central nervous system lymphoma (SCNSL) with a previously confirmed B-cell origin primary lesion but...
- The patients or their legal guardians provide voluntary written informed consent.
- Age\>=18 years, both male and female.
- Karnofsky Performance Status (KPS) score\>=40.
- Patients deemed unsuitable for methotrexate (MTX)-based systemic chemotherapy ("unfit"), including but not limited to: patients assessed as unsuitable for chemotherapy or frail according to a simplified Geriatric...
- Life expectancy of greater than 3 months, as judged by the investigator.
- Patients with parenchymal lesions (\>10\ 10mm ) on contrast-enhanced cranial MRI or those with leptomeningeal disease only, require cytological examination of cerebrospinal fluid (CSF) to confirm the presence of...
- If the patients have received prior anti-tumor therapy, all treatment-related non-hematologic toxicities must have recovered to Grade 1 or baseline (according to NCI CTCAE version 5.0, with the exception of alopecia).
- Bone marrow and organ function must meet the following criteria (without transfusion, G-CSF support, or corrective therapy within 14 days prior to informed consent):
- Hematological: Absolute neutrophil count (ANC) \>=1.5\ 10\^9/L (1500/mm\^3), platelets \>=75\ 10\^9/L, hemoglobin\>=8 g/dL (If bone marrow is involved, then platelets\>=50\ 10\^9/L, ANC \>=1.0\ 10\^9/L, and...
- Hepatic: Total bilirubin \<=1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<=2.5 × ULN.
- Renal: Serum creatinine \ =60 mL/min.
- Coagulation: INR \<=1.5 × ULN; PT and APTT \<=1.5 × ULN (unless the subject is receiving anticoagulant therapy and, at screening, PT and APTT are within the anticipated therapeutic range for the anticoagulant regimen).
- For the people of reproductive age women and fertile men, during the entire study period and within 3 months after the interruption of treatment, they must not have any conception plans with their partners. During the...
- Willingness and ability to undergo multiple MRI/CT scans and an expected ability to undergo lumbar puncture. Ability to swallow oral medication without difficulty.
What rules you out
- The patients with secondary central nervous system lymphoma (SCNSL) who have lesions outside the CNS and require systemic treatment.
- Received chemotherapy, radiotherapy, immunotherapy or antibody-based treatments for anti-tumor purposes within 4 weeks prior to the first administration (or within 5 half-lives), those who had used small molecule...
- Receipt of any vaccine (including but not limited to vaccines for COVID-19, influenza, pneumonia, shingles, hepatitis B, etc.) within 4 weeks before taking the medicine for the first time.
- Concurrent enrollment in another treatment clinical study, or less than 4 weeks between the last dose of prior clinical trial treatment and the first dose in this study.
- Previous treatment with thiotepa, PD-1 inhibitors, or BTK inhibitors is not excluded by default but requires benefit-risk assessment by the investigator. people with a history of Grade \>=3 immune-related adverse events...
- History of active bleeding within 4 weeks before the first dose; need for therapeutic anticoagulation during the study (e.g., warfarin or vitamin K antagonists); or any condition associated with elevated bleeding risk...
- Treatment with moderate or strong CYP3A4/5 inhibitors or inducers is required within 2 weeks before the first administration or during the study period.
- Concurrent presence of other malignant tumors requiring antineoplastic treatment.
- Having uncontrolled or significant cardiovascular diseases, including (but not limited to):
- Any of the following conditions occurring within 6 months before the first administration: congestive heart failure with New York Heart Association class \>= 3, myocardial infarction, unstable angina pectoris...
- Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, unclassified cardiomyopathy);
- A history of clinically significant QTc interval prolongation, second-degree type II atrioventricular block, third-degree atrioventricular block, or a QTc interval \> 470ms (for females) and \> 450ms (for males);
- Atrial fibrillation (EHRA class\>= 2b);
- Poorly controlled hypertension, which is deemed unsuitable for study participation by the investigator.
- Active uncontrolled infection requiring intravenous antimicrobial treatment.
- Patients with active chronic hepatitis B, active chronic hepatitis C, or syphilis. Patients who test positive for hepatitis B surface antigen or hepatitis C virus antibody during the screening period must undergo...
- Patients with a known history of HIV infection and/or AIDS.
- Clinically significant gastrointestinal abnormalities that may affect drug intake, transport, or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction), or total gastrectomy.
- Autologous transplantation within 3 months, or organ or allogeneic stem cell transplantation within 6 months, before signing the informed consent form.
- Pregnancy or lactation.
- Stroke or intracranial hemorrhage within 6 months before first dosing, excluding post-surgical sequelae of intracranial bleeding.
- History or current presence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, or similar conditions, deemed by the researcher as rendering the subject unsuitable for participation in...
- Participants whom the investigator considers unsuitable for the study due to existing kidney, nerve/mental, liver, or endocrine diseases, or for any other reason judged by the researcher.
- Exclude patients with active autoimmune disease or a history of it, including but not limited to: immune-related neurologic disorders, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barré syndrome...
- Major surgery within 28 days prior to the first study dose, as determined by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.