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Linperlisib Combined With Immunochemotherapy in Relapsed/Refractory LBCL | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Linperlisib Combined With Immunochemotherapy in Relapsed/Refractory LBCL

An Open-label, Multicenter, Multi-cohort Clinical Study of Linperlisib Combined With Standard Immunochemotherapy in the Treatment of Relapsed/Refractory Large B-Cell Lymphoma Failing to First-line Therapy

NCT06489808•Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

Summary

To evaluate the efficacy and safety of Linperlisib combined with standard immunochemotherapy in patients with R/R LBCL.

Detailed Description

This is a phase 2, open-label, multicenter, multi-cohort study evaluating the efficacy and safety of Linperlisib combined with standard immunochemotherapy in the treatment of relapsed/refractory LBCL after first-line treatment. This study is divided into a safety run-in phase and a dose expansion phase.The primary objective of the safety run-in phase was to determine the recommended dose for the dose expansion phase based on dose-limiting toxicities (DLTs). The dose expansion phase consisted of Cohort 1 and Cohort 2.Cohort 1 was transplant-ineligible patients who received Linperlisib in combination with R-Gemox at RP2D for 6 cycles.Cohort 2 consisted of patients scheduled for transplantation who received 3 cycles of Linperlisib combined with R-ICE/DHAP/GVM regimen, followed by autologous hematopoietic stem cell transplantation in responding patients

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histologically confirmed large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma unspecified (DLBCL, NOS), follicular lymphoma grade 3B (FL, 3B), high-grade B-cell lymphoma unspecified (HGBCL, NOS), DLBCL/HGBCL with MYC and BCL2 rearrangements, FL transformed DLBCL without a previous history of indolent lymphoma.
•2. Relapsed or refractory after first-line immunochemotherapy (which must include CD20 monoclonal antibody and anthracycline) 1)Refractory is defined as failure to achieve a complete response to first-line therapy (excluding patients who are intolerant to first-line therapy), including progressive disease (PD) as the best response to first-line therapy; stable disease (SD) as the best response after at least 4 cycles of first-line therapy (eg, 4 cycles of R-CHOP); partial response (PR) as the best response after at least 6 cycles of first-line therapy with biopsy-confirmed residual disease or disease progression within 12 months of initiating first-line therapy; complete response to first-line therapy followed by progression within 12 months after the end of therapy. 2)Relapse was defined as a complete response to first-line therapy followed by progression confirmed more than 12 months after the end of therapy.
•3. Subjects must have at least 1 measurable lesion/evaluable lesion that meets the 2014 version of the Lugano Lymphoma Evaluation Criteria.
•4. Subjects has no known or suspected central nervous system involvement by lymphoma.
•5. Previous treatment with any antineoplastic therapy (including radiation therapy, chemotherapy, hormonal therapy, surgery, or molecular targeted therapy) for which participation in this trial must have exceeded 2 weeks or 5 drug half-lives, whichever is shorter.
•6. Age ≥ 18 years.
•7. ECOG score 0-2.
•8. Expected survival ≥ 3 months.
•9. Women of Childbearing Potential subjects must have a negative serum/urine pregnancy test within 7 days prior to the first dose; female subjects of childbearing potential and male subjects with partners of childbearing potential, as well as their partners, should agree to use effective contraception from signing the ICF until 6 months after the last dose of study drug.
•10. Able to comply with the trial protocol as judged by the investigator.
+2 more criteria

Exclusion Criteria

•1. Other malignancies within the last 5 years, except radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the breast, and carcinoma in situ of the cervix.
•2. Previous autologous or allogeneic hematopoietic stem cell transplantation.
•3. History of Richter transformation.
•4. Received \> 1 line of systemic antineoplastic therapy.
•5. Prior treatment with PI3K inhibitors.
•6. Known hypersensitivity to trial products.
•7. Active viral, bacterial, or fungal infection requiring treatment (eg, pneumonia, etc.).
•8. Requiring prolonged systemic hormones (at doses equivalent to \> 10 mg prednisone/day) or any other form of immunosuppressive therapy. Subjects taking inhaled or topical corticosteroids may be enrolled.
•9. Concomitant diseases and medical history:
•1. Multiple factors affecting oral medication (e.g. inability to swallow, chronic diarrhea, ileus, etc.).
+8 more criteria

Locations (1)

Institute of Hematology & Blood Disease Hospital

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

May 28, 2024

Primary Completion Date

December 31, 2026

Completion Date

May 31, 2027

Last Updated

July 8, 2024

Enrollment

ESTIMATED participants

Conditions

Relapsed/Refractory Large B-Cell Lymphoma

Interventions

Linperlisib

DRUG

Rituximab

DRUG

Gemcitabine

DRUG

Oxaliplatin

DRUG

Ifosfamide

DRUG

Carboplatin

DRUG

Etoposide

DRUG

Dexamethasone

DRUG

Cisplatin

DRUG

Ara-C

DRUG

Vinorelbine

DRUG

Mitoxantrone hydrochloride liposome

DRUG

Contacts

Wei Liu, MD

CONTACT

+86 022-23608463 liuwei@ihcams.ac.cn

Lugui Qiu, MD

CONTACT

+86 022-23908461 qiulg@ihcams.ac.cn

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Relapsed/Refractory Large B-cell Lymphoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 8, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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