Linperlisib-based Treatment Regimen in Newly Diagnosed Nodal T-follicular Helper Cell Lymphoma (nTFHL)

NCT06347653 | Recruiting Phase 2

• 1 other identifier: 2023KT127
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nodal T-follicular Helper Cell Lymphoma

Keywords

nodal T-follicular helper cell lymphoma; linperlisib; autologous hematopoietic stem cell transplantation; maintenance treatment

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  PFS will be calculated from the start of study drug treatment to the date of disease progression, death, or last follow-up, as appropriate.

  2 year

Secondary Outcomes (6)

• ORR

  After 6 cycles of induction therapy ，average of 4.2 month and post transplantation

• CR rate

  After 6 cycles of induction therapy ，average of 4.2 month and post transplantation

• Success rate of stem cell collection

  1day before performing an autologous hematopoietic stem cell transplant

• overall survival (OS)

  2 year

• time to next anti-lymphoma treatment

  2 year

Study Arms (1)

linperlisib combined with CHOP regimen

EXPERIMENTAL

Drug: linperlisib combined with CHOP regimen

Interventions

linperlisib combined with CHOP regimen DRUG

Induction therapy: cyclophosphamide 750 mg/m2 day1, doxorubicin 40-50 mg/m2 day1, vincristine 1.4 mg/m2 (max 2 mg) day1, prednisone 100 mg day1-5, linperlisib 80mg once a day，day1-21, repeat every 21 days, for 6 cycle. Consolidation therapy: high dose chemotherapy followed by autologous hematopoietic stem cell transplantation. Maintenance therapy: linperlisib 80 mg day1-28, up to 12 cycles.

linperlisib combined with CHOP regimen

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 classification);
• 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 (day 1 of cycle 1). If a urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required.WOCBP subjects and male subjects whose partners are WOCBP should agree to use effective contraception from the time of signing the ICF until 6 months after the last dose of study 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 factor or other related medical support within 14 days prior to administration of study drug):
• 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; platelets (PLT) ≥ 100 x 109/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 creatinine clearance ≥60 mL/min (Cockcroft-Gault formula);
• 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 ratio (INR) ≤ 1.5 x ULN; activated partial thromboplastin time (APTT) ≤ 1.5 x ULN.
• Volunteer to participate in clinical research and sign an informed consent form, willing to follow and capable of completing all trial procedures.

You may not qualify 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. Subjects 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 the breast and carcinoma in situ of the cervix, excepted
• 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 receiving appropriate medication;
• 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 vasculitis;

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Bejing Cancer Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Interventions

VAP-cyclo protocol

Study Officials

• PING WEI LIU, Master

  Peking University Cancer Hospital & Institute

  STUDY DIRECTOR

Central Study Contacts

PING WEI LIU, Master

CONTACT

0086-13522796323; dreaming2217@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: April 4, 2024
• Study Start: November 28, 2023
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2030
• Last Updated: April 4, 2024

Record last verified: 2024-04

Locations

CN (1)