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
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.
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.
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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):
Exclusion Criteria:
If a patient has any of the following conditions should not be included in this study:
Medical History and comorbidity
Physical and laboratory findings
Drug: 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.
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
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
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
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
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
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
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.
Started Nov 2023 (actual). Primary completion is estimated for Jan 2027, 38 months after the start.
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