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

• Sponsor: Ruijin Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04789434
• Collaborator: (none)
• Enrollment: 94
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 35.7
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, Large B-Cell, Diffuse; Transplantation; Chemotherapy	Drug: PD-1 Inhibitor Tislelizumab maintenance therapy	Phase 3

Detailed Description

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). 94 patients were randomly divided into two groups according to the ratio of 1:1. The whole trial included screening period (day-28 to day-1), treatment period (Tislelizumab, 200mg every 8 weeks, 12 times) and follow-up period (2 years after the enrollment).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 94 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: PD-1 Inhibitor Tislelizumab Maintenance Therapy in Newly Diagnosed DLBCL Patients After ASCT: A Multicenter, Randomized Controlled Clinical Study on Efficacy and Safety
• Actual Study Start Date: Jul 9, 2021
• Anticipated Primary Completion Date: Jul 1, 2023
• Anticipated Study Completion Date: Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PD-1 Inhibitor maintenance PD-1 Inhibitor Tislelizumab maintenance therapy dose：200mg frequency：1 time for 2 months duration：2 years	Drug: PD-1 Inhibitor Tislelizumab maintenance therapy; PD-1 Inhibitor Tislelizumab maintenance therapy, 200mg, every 2 months, 12 times
No Intervention: No intervention No intervention

Outcome Measures

Primary Outcome Measures

1. progression-free survival [2-years after enrollment]

   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.

Secondary Outcome Measures

1. complete remission rate [2-years after enrollment]

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

2. overall survival [2-years after enrollment]

   Overall survival was defined as the time from the date of diagnosis to the date of death from any cause. Reported is the percentage of participants with event. of disease progression or relapse, using 2014 Lugano criteria,or death from any cause, whichever occurred first.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Male and female, aged 18-65;

2. newly-diagnosed high risk (aaipi 2-3 and aaipi 1 with large mass) DLBCL patients after autologous stem cell transplantation;

3. Laboratory tests (blood tests, liver and renal function) meet the following requirements:

4. Blood tests: white blood cell count ≥ 3.0 × 109 / L, absolute neutrophil count ≥ 1.5 × 109 / L, hemoglobin ≥ 90g / L, platelet ≥ 75 × 109 / L

5. Liver function: transaminase ≤ 2.5 × upper limit of normal value, bilirubin ≤ 1.5 × upper limit of normal value;

6. Renal function: serum creatinine 44-133 mmol / L;

7. The score of ECOG was 0-2;

8. The subject or his legal representative must provide written informed consent before the special examination or procedure of the study.

Exclusion Criteria:

1. Pregnant or lactating women;

2. Severe complications or infection;

3. Lymphoma involving central nervous system;

4. Participate in other clinical trials at the same time;

5. According to the judgment of the researcher, the patients who are not suitable for this study were selected.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ruijin Hospital	Shanghai	Shanghai	China	200020

Sponsors and Collaborators

• Ruijin Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhao Weili, Vice President, Ruijin Hospital
• ClinicalTrials.gov Identifier: NCT04789434
• Other Study ID Numbers: NHL-PD1-1
• First Posted: Mar 9, 2021
• Last Update Posted: Nov 22, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lymphoma, Large B-Cell, Diffuse; Immune Checkpoint Inhibitors

Study Results

No Results Posted as of Nov 22, 2021