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New treatment option for Nodal T-follicular Helper Cell Lymphoma
Official title Linperlisib-based Treatment Regimen in Newly Diagnosed Nodal T-follicular Helper Cell Lymphoma (nTFHL)
ClinicalTrials.gov ID: NCT06347653
What this study is testing
What is linperlisib combined with CHOP regimen?
linperlisib combined with CHOP regimen is an investigational medicine, given as an once-daily, being studied as a potential treatment for nodal t-follicular helper cell lymphoma.
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 study is conducted to evaluate the efficacy and safety of linperlisib combined with CHOP regimen followed by autologous hematopoietic stem cell transplantation and linperlisib monotherapy maintenance for newly diagnosed nTFHL patients.
- Phase 2: a mid-size study of how well it works
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 65
You may be able to join if
- Histologically confirmed nTFHL classified by WHO-HAEM5, including nodal TFH cell lymphoma, angioimmunoblastic-type, nodal TFH cell lymphoma...
- Patients planning to receive autologous hematopoietic stem cell transplantation;
- No previous systemic treatment before enrollment.;
- There is at least one measurable lesion: the longest diameter (LDi) of the lymph node lesion is greater than 1.5 cm, or the LDi of one extra lymph...
- Age range from 18 to 65 years old, regardless of gender;
You likely can't join if
- If a patient has any of the following conditions should not be included in this study:
- Known allergy to the active ingredients or excipients of linperlisib and CHOP regimens.
- Patients with factors that affect oral medications (such as inability to swallow, chronic diarrhea, and intestinal obstruction);
- Medical History and comorbidity
- The subject had any active, known, or suspected autoimmune disease. people who are in a stable state and do not require systemic immunosuppressive...
- Known history of interstitial pneumonia;
See the full eligibility criteria
- Histologically confirmed nTFHL classified by WHO-HAEM5, including nodal TFH cell lymphoma, angioimmunoblastic-type, nodal TFH cell lymphoma, follicular-type, Nodal TFH cell lymphoma, NOS
- Patients planning to receive autologous hematopoietic stem cell transplantation;
- No previous systemic treatment before enrollment.;
- There is at least one measurable lesion: the longest diameter (LDi) of the lymph node lesion is greater than 1.5 cm, or the LDi of one extra lymph node lesion is greater than 1 cm (according to the 2014 Lugano...
- Age range from 18 to 65 years old, regardless of gender;
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)≤2;
- Expected survival time≥12 weeks;
- Adequate bone marrow and organ functions; For female participants of childbearing period, a negative urine or serum pregnancy test should be performed with 1 week prior to receiving first dose of investigational drug...
- Adequate organ and bone marrow function without severe hematopoietic abnormalities and abnormal heart, lung, liver, kidney, thyroid function and immunodeficiencies (no blood transfusion, granulocyte colony-stimulating...
- Routine blood tests (not transfused, not on granulocyte colony-stimulating factor (G-CSF), not corrected with medication within 14 days prior to screening): hemoglobin (Hb) ≥ 90 g/L; neutrophils (ANC) ≥ 1.5 x 10 9/L...
- Biochemical tests: TBIL \<1.5 × upper limit of normal range (ULN); glutamate alanine aminotransferase (ALT) and glutamate aspartate aminotransferase (AST) ≤2.5 × ULN; serum creatinine (Cr) ≤1.25 × ULN or endogenous...
- Coagulation (unless the subject is receiving anticoagulant therapy and coagulation parameters (PT/INR and APTT) are within the expected range for treatment with anticoagulants at screening): international normalized...
- Volunteer to participate in clinical research and sign an informed consent form, willing to follow and capable of completing all trial procedures.
- If a patient has any of the following conditions should not be included in this study:
- Known allergy to the active ingredients or excipients of linperlisib and CHOP regimens.
- Patients with factors that affect oral medications (such as inability to swallow, chronic diarrhea, and intestinal obstruction);
- Medical History and comorbidity
- The subject had any active, known, or suspected autoimmune disease. people who are in a stable state and do not require systemic immunosuppressive therapy are admitted;
- Known history of interstitial pneumonia;
- Current or previous history of other malignancies within 2 years prior to study enrollment.Radically treated basal cell carcinoma of the skin, papillary thyroid carcinoma, squamous skin carcinoma, carcinoma in situ of...
- Received systemic antitumor therapy, including chemotherapy, immunotherapy, and biotherapy (tumor vaccines, cytokines, or growth factors used to control cancer) within 28 days prior to study enrollment.
- Received autologous or allogeneic hematopoietic stem cell transplantation;
- Patients with active tuberculosis (TB) should be excluded.
- Severe acute or chronic infections requiring systemic treatment;
- Patients with hypertension that is not well controlled with antihypertensive medications (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg)
- Poor diabetes control (fasting blood glucose (FBG) \> 10mmol/L);
- Patients with heart failure (New York Heart Association standard Class III or IV), poor coronary artery disease control or arrhythmia, or a history of myocardial infarction within the 6 months prior to screening despite...
- Had clinically significant bleeding symptoms or definite bleeding tendency within 3 months before enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, stool occult blood ++ or above at baseline, or...
- Renal failure requiring hemodialysis or peritoneal dialysis;
- Urine routine indicated urinary protein ≥++, and 24-hour urinary protein quantity \> 1.0 g；
- Patients who have had major surgery or severe trauma have had the effects of the surgery or trauma resolved for less than 28 days prior to enrollment；
- Complicated interstitial lung disease or history of severely impaired lung function;
- Patients requiring systemic therapy with corticosteroids (\> 10 mg/day of prednisone or equivalent) or other immunosuppressive agents within 14 days prior to administration of study drug. Inhaled or topical steroids and...
- Physical and laboratory findings
- A known history of human immunodeficiency virus (HIV) infection (i.e., HIV antibody positive).
- Active hepatitis [Hepatitis B: Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive and ALT above the upper limit of detection; Hepatitis C: Hepatitis C virus (HCV) ribonucleic acid (RNA) positive and ALT above...
- Any medical history or disease evidence that may interfere with the study results or other conditions that investigators consider inappropriate for the study.
- Pregnant or lactating women.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.