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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| linperlisib combined with CHOP regimen | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | ORR is defined as sum of CR and PR rates, as assessed by the Investigator according to the Lugano Classification | After 6 cycles of induction therapy ,average of 4.2 month and post transplantation |
| CR rate |
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Inclusion 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 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):
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:
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
Physical and laboratory findings
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| PING WEI LIU, Master | Contact | 0086-13522796323 | dreaming2217@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| PING WEI LIU, Master | Peking University Cancer Hospital & Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bejing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| C036337 | VAP-cyclo protocol |
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CR rate is defined as the percentage of patients showing complete response as assessed by the Investigator according to the Lugano Classification.
| 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 . | 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. | 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 | 2 year |
| adverse events | incidence of adverse event, proportion of patients with dose adjustment of linperlisib | 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. |