PD-1 Inhibitor Tislelizumab Maintenance Therapy in Newly Diagnosed DLBCL Patients After ASCT

NCT04789434 | Unknown Phase 3 DMC

• 1 other identifier: NHL-PD1-1
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, randomized controlled, prospective clinical trial. The objective is to investigate the efficacy and safety of Tislelizumab maintenance therapy in newly diagnosed diffuse large B-cell lymphoma (DLBCL) patients after autologous hematopoietic stem cell transplantation (ASCT).

Conditions

Lymphoma, Large B-Cell, Diffuse; Transplantation; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  Progression-free survival was defined as the time from the date of diagnosis 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.

  2-years after enrollment

Secondary Outcomes (2)

• complete remission rate

  2-years after enrollment

• overall survival

  2-years after enrollment

Study Arms (2)

PD-1 Inhibitor maintenance

EXPERIMENTAL

PD-1 Inhibitor Tislelizumab maintenance therapy dose：200mg frequency：1 time for 2 months duration：2 years

Drug: PD-1 Inhibitor Tislelizumab maintenance therapy

No intervention

NO INTERVENTION

No intervention

Interventions

PD-1 Inhibitor Tislelizumab maintenance therapy DRUG

PD-1 Inhibitor Tislelizumab maintenance therapy, 200mg, every 2 months, 12 times

PD-1 Inhibitor maintenance

Eligibility Criteria

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

You may qualify if:

• Male and female, aged 18-65;
• newly-diagnosed high risk (aaipi 2-3 and aaipi 1 with large mass) DLBCL patients after autologous stem cell transplantation;
• Laboratory tests (blood tests, liver and renal function) meet the following requirements:
• Blood tests: white blood cell count ≥ 3.0 × 109 / L, absolute neutrophil count ≥ 1.5 × 109 / L, hemoglobin ≥ 90g / L, platelet ≥ 75 × 109 / L
• Liver function: transaminase ≤ 2.5 × upper limit of normal value, bilirubin ≤ 1.5 × upper limit of normal value;
• Renal function: serum creatinine 44-133 mmol / L;
• The score of ECOG was 0-2;
• The subject or his legal representative must provide written informed consent before the special examination or procedure of the study.

You may not qualify if:

• Pregnant or lactating women;
• Severe complications or infection;
• Lymphoma involving central nervous system;
• Participate in other clinical trials at the same time;
• According to the judgment of the researcher, the patients who are not suitable for this study were selected.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200020, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

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

Central Study Contacts

Weili Zhao, doctor

CONTACT

+862164370045; zwl_trial@163.com

Pengpeng Xu, doctor

CONTACT

+862164370045; pengpeng_xu@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President

Study Record Dates

• First Submitted: March 6, 2021
• First Posted: March 9, 2021
• Study Start: July 9, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2024
• Last Updated: November 22, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)