Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Peripheral T-cell Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Apatinib

Azacitidine

Dasatinib

Antimetabolites

Enzyme Inhibitors

Protein Kinase Inhibitors

Tyrosine Kinase Inhibitors

Tyrosine

T1 subtypes based on next generation sequencing results

T2 subtypes based on next generation sequencing results

T3.1 subtypes based on next generation sequencing results

T3.2 subtypes based on next generation sequencing results

Azacitidine Injection，SC and Dasatinib PO will be administered in T1 subtypes

Azacitidine Injection

Azacitidine Injection，SC and Linperlisib PO will be administered in T2 subtypes

Linperlisib

Tucidinostat PO and SHR2554 PO will be administered in T3.1 subtypes

Tucidinostat

SHR2554

Camrelizumab and Apatinib will be administered in T3.2 subtypes

Camrelizumab

Weili Zhao

Pengpeng Xu

Weili Zhao, M.D. and Ph.D

This is a multicenter, prospective, open-label, interventional umbrella study to evaluate the efficacy and safety of targeted therapies guided by molecular subtypes in patients with relasped or refractory peripheral T-cell lymphoma.

A Umbrella Study in R/R PTCL Guided by Molecular Subtypes

A Umbrella Study in Relapsed/Refractory Peripheral T-cell Lymphoma Guided by Molecular Subtypes

Percentage of participants with complete and partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria.

Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.

Progression-free survival was defined as the time from the date of enrollment until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.

Overall survival was defined as the time from the date of enrollment to the date of death from any cause.

Duration of response was defined as the time from the date of favorable response until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

Ruijin Hospital

First Deputy Director, Hematology Department

Lymphoma, Mantle-Cell

Mantle Cell Lymphoma

Venetoclax

Obinutuzumab

Antineoplastic Agents, Immunological

Patients with relapsed refractory lymphoblastic mantle cell lymphoma who have not previously received treatment with PI3K inhibitors and BCL-2 inhibitors

Combined induction period: Linprixate: 80 mg, oral (pre - and post meal), once a day; Otuzumab: 1000 mg/dose, intravenous infusion, administered on the first day (1st cycle is 1, 8, 15 days); (Up to 6 cycles, administration cycle can be adjusted according to clinical treatment conditions); Vineclavone: increase from 40mg, 100mg, and 200mg to 400mg within 4 weeks, followed by a treatment cycle of 400mg orally once a day; (Starting from the third cycle), one cycle every 28 days, for a total of 6 cycles。 Maintenance treatment period: Linprixate: 80 mg, oral (both before and after meals), once a day; Vinecala: 400 mg, oral, once daily; Cycle every 28 days.

Linperlisib in combination with Obinutuzumab and Venetoclax

Xiuhua Sun, Doctor

This is a single arm, open label, national multicenter clinical study included patients with relapsed and refractory blastoid variant of mantle cell lymphoma (R/R BV-MCL), aiming to evaluate the efficacy of a chemotherapy free triple therapy of PI3K inhibitor (Linperlisib) combined with anti-CD20 monoclonal antibody (Obinutuzumab) and BCL-2 inhibitor (Venetoclax) in R/R BV-MCL patients.

This is a single arm, open label, national multicenter clinical study that included 10 cases of relapsed and refractory blastoid variant of mantle cell lymphoma (R/R BV-MCL). The aim was to evaluate the efficacy of a chemotherapy free triple therapy consisting of PI3K inhibitor (Linperlisib) combined with anti-CD20 monoclonal antibody (Obinutuzumab) and BCL-2 inhibitor (Venetoclax) in patients with R/R BV-MCL. It is divided into a combined induction period and a maintenance treatment period. All enrolled patients receive the following combined treatment: combined induction period: Linperlisib: 80 mg, orally (pre - and post meal), once a day; Obinutuzumab: 1000 mg/dose, intravenous infusion, administered on the first day (1st cycle is 1, 8, 15 days); (Up to 6 cycles, administration cycle can be adjusted according to clinical treatment conditions); Venetoclax: increase from 40mg, 100mg, and 200mg to 400mg within 4 weeks, followed by a treatment cycle of 400mg orally once a day; (Starting from the third cycle). Every 28 days, there are a total of 6 cycles. Maintenance treatment period: Linperlisib: 80 mg, oral (both before and after meals), once a day; Venetoclax: 400 mg, oral, once daily. Cycle every 28 days. After 6 cycles of combined treatment, the efficacy is evaluated according to the Lugano2014 standard. If complete remission (CR) or partial remission (PR) is achieved, maintenance treatment with a combination of 80 mg of linprixate and 400 mg of vinclair is administered every 28 days until disease progression, intolerable toxicity, or other reasons lead to discontinuation. If it is stable disease (SD) and progressive disease (PD), patients will be excluded from the group. The main research endpoint is Objective Response Rate (ORR). Secondary study endpoints include progression free survival (PFS); Overall survival (OS), duration of response (DOR), and safety: incidence and severity of adverse events (AE) and severe adverse events (SAE). Safety: incidence and severity of adverse events (AE) and severe adverse events (SAE).

Linperlisib Plus Obinutuzumab and Venetoclax for Relapsed and Refractory Blastoid Variant of Mantle Cell Lymphoma.

A Single-arm, Open-label, National Multi-center Clinical Study of Linperlisib in Combination With Obinutuzumab and Venetoclax in the Treatment of Relapsed and Refractory Blastoid Variant of Mantle Cell Lymphoma (R/R BV-MCL)

The ORR rate of patients with Linperlisib in combination with Obinutuzumab and Venetoclax for relapsed and refractory blastoid variant of mantle cell lymphom

The time from the start of clinical trials to the occurrence (in any aspect) of tumor progression or death due to any reason

The time from the start of tumor treatment to (for any reason) death.

The time from the first judgment of complete remission (CR) or partial remission (PR) to the discovery of disease progression (PD).

Refers to adverse medical events that occur in the clinical trial process of the subject

Dalian Medical University

Chief physician

Antirheumatic Agents

Anti-Inflammatory Agents

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Prednisone

Vincristine

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

PING WEI LIU, Master

PING WEI LIU, master

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.

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

A Single Arm, Open Label, Multicenter Clinical Trial of Linperlisib Combined With CHOP Regimen Followed by Autologous Hematopoietic Stem Cell Transplantation and Linperlisib Monotherapy Maintenance for Newly Diagnosed Nodal T-follicular Helper Cell Lymphoma (nTFHL) Patients

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

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

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

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

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

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Umbrella Study in R/R PTCL Guided by Molecular Subtypes	NCT05559008	Peripheral T Ce...	Azacitidine Inj... Dasatinib Linperlisib Tucidinostat SHR2554 Camrelizumab Apatinib	18 Years -	Ruijin Hospital
A Umbrella Study in R/R PTCL Guided by Molecular Subtypes	NCT05559008	Peripheral T Ce...	Azacitidine Inj... Dasatinib Linperlisib Tucidinostat SHR2554 Camrelizumab Apatinib	18 Years -	Ruijin Hospital
Linperlisib Plus Obinutuzumab and Venetoclax for Relapsed and Refractory Blastoid Variant of Mantle Cell Lymphoma.	NCT06324994	Mantle Cell Lym...	Linperlisib in ...	18 Years -	Dalian Medical University
Linperlisib-based Treatment Regimen in Newly Diagnosed Nodal T-follicular Helper Cell Lymphoma (nTFHL)	NCT06347653	Nodal T-follicu...	linperlisib com...	18 Years - 65 Years	Peking University

Spots Global Cancer Trial Database for linperlisib

Every month we try and update this database with for linperlisib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for linperlisib

Every month we try and update this database with for linperlisib cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for linperlisib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.