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RecruitingNCT06347653Updated Apr 4, 2024

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

A Phase 2 interventional study of linperlisib combined with CHOP regimen in Nodal T-follicular Helper Cell Lymphoma, sponsored by Peking University. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-04-04.

Sponsored by Peking University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2023; still recruiting 2 years 10 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
54
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Nodal T-follicular Helper Cell Lymphoma

Keywords

  • nodal T-follicular helper cell lymphoma
  • linperlisib
  • autologous hematopoietic stem cell transplantation
  • maintenance treatment
03

In context

Lead sponsor

Peking University is the lead sponsor of 418 studies on the registry; 122 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
54 participants (estimated)

Study arms

  • Experimental
    linperlisib combined with CHOP regimen

    Drug: linperlisib combined with CHOP regimen

Interventions

  • Druglinperlisib 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.

06

What researchers measure

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.

    Time frame: 2 year

Secondary outcomes

  1. ORR

    ORR is defined as sum of CR and PR rates, as assessed by the Investigator according to the Lugano Classification

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

  2. CR rate

    CR rate is defined as the percentage of patients showing complete response as assessed by the Investigator according to the Lugano Classification.

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

  3. Success rate of stem cell collection

    Success rate was assessed as the number of participants who achieved the target collection of CD34+cells ≥ 2×10\^6/kg .

    Time frame: 1day before performing an autologous hematopoietic stem cell transplant

  4. overall survival (OS)

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

    Time frame: 2 year

  5. time to next anti-lymphoma treatment

    TTNLT will be calculated from the start of study drug treatment to the date of starting next anti-lymphoma treatment

    Time frame: 2 year

  6. adverse events

    incidence of adverse event, proportion of patients with dose adjustment of linperlisib

    Time frame: Toxicity will be graded according to the NCI-CTCAC version 4.0, from the first day of the first cycle of induction therapy to 30 days after the last dose of study drug.

07

Study locations

1 of 1 sites recruiting
  • Bejing Cancer Hospital
    Beijing, Beijing Municipality, China
    • PING WEI LIU, master · Contact · 0086-13522796323
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2023 (actual). Primary completion is estimated for Jan 2027, 38 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 13, 2023
First posted
Apr 4, 2024
StartActual
Nov 28, 2023
Primary completionEst.
Jan 31, 2027
CompletionEst.
Jan 31, 2030
Last update
Apr 4, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06347653
Lead sponsor
Peking University
Responsible party
Jun Zhu (Director, Peking University) — Principal investigator
First posted
Apr 4, 2024
Start date
Nov 28, 2023
Primary completion
Jan 31, 2027 (estimated)
Completion
Jan 31, 2030 (estimated)
Last update
Apr 4, 2024

Study contacts

PING WEI LIU, Master
Contact
dreaming2217@hotmail.com
0086-13522796323
PING WEI LIU, Master
study director · Peking University Cancer Hospital & Institute

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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