Sintilimab Plus R-GemOx as Second-line Salvage Therapy in Patients With R/R DLBCL

NCT04659434 | Unknown Phase 2

• 1 other identifier: IR2020001398
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the addition of Sintilimab to current 2nd line salvage therapy of Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) for patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL). All patients will receive four cycles of sintilimab plus R-GemOx. Afterwards, 1) patients who achieve CR assessed by PET-CT and are eligible for autologous stem cell transplantation (ASCT) will undergo ASCT. After transplantation, patients will receive sintilimab monotherapy up to 8 cycles or until disease recurrence and progression, death, intolerance and toxicity, withdrawal of informed consent, or other reasons specified in the protocol. 2) Patients who achieve CR assessed by PET-CT and are not eligible for ASCT will directly receive sintilimab monotherapy as maintenance treatment for a maximum of 8 cycles as described above. 3) Patients achieved PR, SD or PD assessed by PET/CT will withdraw from this study and receive proper treatment based on investigator's decision.

Conditions

Diffuse Large B Cell Lymphoma; Relapsed Diffuse Large B-Cell Lymphoma; Refractory Diffuse Large B-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Complete response rate

  Complete response rate after treated by Sintilimab and R-GemOx

  6 weeks after the last dose of the combination therapy (each cycle is 21 days)

Secondary Outcomes (3)

• Over response rate (ORR)

  6 weeks after the last dose of the combination therapy (each cycle is 21 days)

• Overall Survival (OS)

  2 years

• Rate of grade 3 or 4 treatment related adverse effect

  Time Frame: Up to 30 days after the last cycle of per-protocol treatment and 90 days after last dose of anti-PD-1 antibody (each cycle is 28 days)

Study Arms (1)

treatment group

EXPERIMENTAL

Sintilimab 200mg ivdrip Q3W; Rituximab 375mg/m2 ivdrip; Gemcitabine 1000mg ivdrip; Oxaliplatin 100mg/m2 ivdrip

Drug: Sintilimab

Interventions

Sintilimab DRUG

Patients receive sintiliman+R-GemOx three weeks for a cycle, detailed as follows: Combination therapy * Anti-PD-1 antibody (sintilimab): Fixed dose of 200 mg every 3 weeks, d0, intravenous drip (without pretreatment), infusion time: 30 mintutes (no less than 20 mins, no more than 60 mins), for 4 cycles * R-GemOx: Rituximab 375mg/m2, d1; Gemcitabine 1000mg, d2; Oxaliplatin 100mg/m2, d2; every 3 weeks for a cycle, 4 cycle as protocol specified. Monotherapy: -Anti-PD-1 antibody (sintilimab): Fixed dose of 200 mg every 3 weeks, d0, intravenous drip (without pretreatment), infusion time: 30 mintutes (no less than 20 mins, no more than 60 mins), for 8 cycles

Also known as: IBI308

treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willingness to provide written informed consent.
• Age range from 18 to 80 years;
• Pathologically confirmed CD20+ diffuse large B-cell lymphoma
• According to Lugano 2014, at least one measurable nodular lesion with a length of greater than 15 mm, or extranodal lesion greater than 10 mm, lesion on FDG-PET scan demonstrates uptake);
• Diffuse large B-cell lymphoma patients failed to first-line rituximab based chemotherapy including anthracycline or anthracycline
• Patients are allowed to receive palliative radiotherapy, but the last time radiotherapy cannot be within 7 days before the first study drug administration;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
• Adequate organ function
• Expectation survival time over 3 months;

You may not qualify if:

• History of other malignancy within the past 5 years (except for 1. basal cell carcinoma of the skin and 2. carcinoma in situ of the cervix and 3. patients who had received treatment for the purpose of cure and had not developed a malignant tumor with a known active disease in the previous 5 years);
• Patients who had received other antitumor therapy (including corticosteroid therapy, immunotherapy) or participated in other clinical studies within 4 weeks before the start of the enrollment (if patients received small-molecule targeted drug therapy, they could be included in the study if the drug was discontinued for more than 5 half-lives), or had not recovered from the previous toxicity;
• Previous treatment with anti-PD-1 antibody, anti-PD-L1 antibody or other medications that stimulates or collaboratively inhibits T cell receptors
• Patients previously received anti-CD20 antibody combined GemOx regimen;
• Evidence of central nervous system invasion;
• Patients received systemic treatment of traditional Chinese herb with anti-tumor indications or immunomodulatory drugs (including thyroxin, interferon and interleukinin, except for local use to control pleural effusions) within 2 weeks before first administration;
• Patients with autoimmune diseases requiring treatment or with a history of syndrome requiring systemic use of steroid immunosuppressive agents, such as hypophysitis, pneumonia, colitis, hepatitis, nephritis, hyperthyroidism, hypothyroidism, etc;
• Patients received systemic glucocorticoid therapy (excluding nasal spray, inhaled or other topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days prior to the first administration;
• Clinically uncontrollable pleural effusion/peritoneal effusion (patients who do not need drainage effusion or do not significantly increase the effusion after 3 days of drainage can be enrolled);
• Patients who have had previous organ transplants (except autologous hematopoietic stem cell transplants);
• Patients are allergic to sintilimab, CD20 monoclonal antibody and GemOx regimen
• Patients has not fully recovered from toxicity and/or complications due to any intervention prior to initiation of treatment (i.e., ≤ grade 1 or baseline, excluding fatigue or hair loss);
• A confirmed history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive);
• A confirmed history of Novel Coronavirus infection;
• Patients with hepatitis B (HBV HBsAg positive and HBV-DNA≥105), hepatitis C (HCV) infection (HCV antibody positive and HCV-RNA detectable); And subjects with other acquired or congenital immune deficiency diseases, including but not limited to hiv-infected;

Sponsors & Collaborators

• Qian Wenbin: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

sintilimab

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• wenbin Qian

  2nd Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

wenbin Qian

CONTACT

13605801032; qianwb@zju.edu.cn

hui Liu

CONTACT

13819198629

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Hematology Department Director

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 9, 2020
• Study Start: December 10, 2020
• Primary Completion: December 10, 2022
• Study Completion: December 10, 2025
• Last Updated: December 9, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)