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

NCT ID: NCT06347653

Last Updated: 2024-04-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-28
• Study Completion Date: 2030-01-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

linperlisib combined with CHOP regimen

Group Type: EXPERIMENTAL

linperlisib combined with CHOP regimen

Intervention Type: 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.

Interventions

linperlisib combined with CHOP regimen

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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

2. Patients planning to receive autologous hematopoietic stem cell transplantation;

3. No previous systemic treatment before enrollment.;

4. 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);

5. Age range from 18 to 65 years old, regardless of gender;

6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)≤2;

7. Expected survival time≥12 weeks;

8. 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.

9. 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):

1. 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;

2. 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);

3. 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.

10. Volunteer to participate in clinical research and sign an informed consent form, willing to follow and capable of completing all trial procedures.

Exclusion Criteria

If a patient has any of the following conditions should not be included in this study:

1. Known allergy to the active ingredients or excipients of linperlisib and CHOP regimens.

2. Patients with factors that affect oral medications (such as inability to swallow, chronic diarrhea, and intestinal obstruction);

3. Medical History and comorbidity

1. 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;

2. Known history of interstitial pneumonia;

3. 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

4. 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.

5. Received autologous or allogeneic hematopoietic stem cell transplantation;

6. Patients with active tuberculosis (TB) should be excluded.

7. Severe acute or chronic infections requiring systemic treatment;

8. Patients with hypertension that is not well controlled with antihypertensive medications (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg)

9. Poor diabetes control (fasting blood glucose (FBG) > 10mmol/L);

10. 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;

11. 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;

12. Renal failure requiring hemodialysis or peritoneal dialysis;

13. Urine routine indicated urinary protein ≥++, and 24-hour urinary protein quantity > 1.0 g；

14. 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；

15. Complicated interstitial lung disease or history of severely impaired lung function;

16. 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 adrenal hormone replacement at doses > 10 mg/day prednisone efficacy dose are allowed in the absence of active autoimmune disease;

4. Physical and laboratory findings

1. A known history of human immunodeficiency virus (HIV) infection (i.e., HIV antibody positive).

2. 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 the upper limit of detection]; co-infection with Hepatitis B and Hepatitis C;

5. Any medical history or disease evidence that may interfere with the study results or other conditions that investigators consider inappropriate for the study.

6. Pregnant or lactating women.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Jun Zhu

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

PING WEI LIU, Master

Role: STUDY_DIRECTOR

Peking University Cancer Hospital & Institute

Locations

Bejing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

PING WEI LIU, Master

Role: CONTACT

dreaming2217@hotmail.com

0086-13522796323

Facility Contacts

PING WEI LIU, master

Role: primary

0086-13522796323

Other Identifiers

2023KT127

Identifier Type: -

Identifier Source: org_study_id