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Toripalimab Plus Rituximab Followed by R-CHOP for Elderly Patients With Untreated Diffused B Cell Lymphoma | Clinical Trials | Clareo Health

UNKNOWNPHASE1/PHASE2

Toripalimab Plus Rituximab Followed by R-CHOP for Elderly Patients With Untreated Diffused B Cell Lymphoma

Phase Ib/II Study of Toripalimab In Combination With Rituximab Followed by R-CHOP Regimen (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) for Elderly Naïve Patients With Diffuse Large B-cell Lymphoma

NCT04058470•Huiqiang Huang

View on ClinicalTrials.gov

Summary

1. Phase I portion of this study will evaluate the efficacy and saftey of toripalimab plus rituximab in treating untreated elderly diffuse large B cell lymphoma patients. 2. The aim of phase II portion of this study will evaluate the efficacy and saftey of toripalimab plus rituximab followed by R-CHOP(rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) regimen in treating untreated elderly diffuse large B cell lymphoma patients.

Detailed Description

The study consisted of a phase I and II portion. In phase I, patients accepted at least 2 cycles of toripalimab plus rituximab. Another 2 cycles of toripalimab plus rituximab will offered if they achieved CR. In phase II, all patients accpet R-CHOP regimen. If patient get CR after, they will accept 4 cycles of R-CHOP regimen, patients with PR,SD or PD will accept 6 cycles of R-CHOP.

Eligibility

Age

60 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Volunteer to participate in clinical research; fully understand and know the research and sign the Informed Consent Form (ICF); willing to follow and have the ability to complete all trial procedures;
•2. Aged 60-75 years old male or female;
•3. Untreated,without any anti-lymphoma treatment;
•4. DLBCL, or follicular lymphoma grade 3B, or transformed DLBCL, EBV (+) DLBCL, ALK (+) DLBCL, high-grade lymphoma were confirmed by histopathology examination;
•5. Clinical stage II-IV, or stage I with bulky diesase (diameter \> 7.5 cm);
•6. International Prognostic Score (IPI): 2-5;
•7. Paraffin tissue specimens or fresh puncture tissue specimens are available;
•8. Eastern cooperative oncology group score: 0-2;
•9. Estimated survival ≥ 12 months;
•10. There must be at least one evaluate able or measurable lesion that meets the Lugano 2014 Lymphoma criteria \[evaluable lesion: 18F-fluorodeoxyglucose/Positron Emission Tomography (18FDG/PET) examination showing increased lymph node or extranodal uptake (higher than liver) and PET and/or computed tomography (Computed Tomography) CT) features are consistent with lymphoma findings; lesions can be measured: nodular lesions \> 15mm or extranodal lesions \> 10mm (if the only measurable lesion has received radiotherapy in the past, there must be evidence of radiological progress after radiotherapy), and accompanied by increased 18FDG uptake). Except for this, there is no measurable increase in diffuse 18FDG uptake in the liver;
+4 more criteria

Exclusion Criteria

•1. Primary central nervous system lymphoma or secondary central nervous system involvement;
•2. Hemophagocytic syndrome;
•3. Previously treated with immunological checkpoint inhibitors (PD-1, PD-L1, CTLA-4, etc.);
•4. History of severe allergies or allergic reactions to humanized or murine monoclonal antibodies;
•5. Patients with active autoimmune diseases requiring systematic treatment in the past two years (hormone replacement therapy is not considered systematic treatment, such as type I diabetes mellitus, hypothyroidism requiring only thyroxine replacement therapy, adrenocortical dysfunction or pituitary dysfunction requiring only physiological doses of glucocorticoid replacement therapy); Patients with autoimmune diseases who do not require systematic treatment within two years can be enrolled;
•6. Begin the study on subjects requiring systemic glucocorticoid therapy or other immunosuppressive therapy for a given condition within 14 days before treatment \[allowing subjects to use local, ocular, intra-articular, intranasal and inhaled glucocorticoid therapy (with very low systemic absorption); and allowing short-term (\< 7 days) glucocorticoid prophylaxis (e.g., contrast agent overdose) Sensitivity) or for the treatment of non-autoimmune diseases (e.g. delayed hypersensitivity caused by contact allergens), except for tumor reduction due to large tumor burden (prednisone 30mg, bid × 5 days or equivalent dose of other glucocorticoid therapy);
•7. In the past five years, patients with other malignant tumors have undergone radical treatment, except for basal cell carcinoma of skin, squamous cell carcinoma of skin, carcinoma in situ of breast and carcinoma in situ of cervix;
•8. Begin the study and receive systemic antineoplastic therapy within 28 days before treatment, including chemotherapy, immunotherapy, biotherapy (cancer vaccine, cytokines, or growth factors that control cancer), etc.;
•9. The study began with major surgery within 28 days before treatment or radiotherapy within 90 days before treatment;
•10. Start the study and receive Chinese herbal medicine or Chinese patent medicine treatment within 7 days before treatment;
+12 more criteria

Locations (1)

Department of hematology department, Nanfang hospital

Guangzhou, Guangdong, China

Key Dates

Start Date

April 24, 2020

Primary Completion Date

December 30, 2023

Completion Date

December 30, 2025

Last Updated

April 14, 2022

Enrollment

140

ESTIMATED participants

Conditions

Diffuse Large B Cell LymphomaHigh-grade B-cell LymphomaFollicular Lymphoma Grade IIIbTransformed LymphomaEBV-Positive DLBCL, NosALK-Positive Anaplastic Large Cell Lymphoma

Interventions

Toripalimab, Rituximab

DRUG

R-CHOP Protocol

DRUG

Contacts

Huiqiang Huang, Professor

CONTACT

+86 020 87343350 huanghq@sysucc.org.cn

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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: April 14, 2022Data 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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Toripalimab Plus Rituximab Followed by R-CHOP for Elderly Patients With Untreated Diffused B Cell Lymphoma

Inclusion Criteria

Exclusion Criteria

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