Different Immunochemotherapies in Small B-cell Non-Hodgkin Lymphoma (iNHL)

Active, not recruiting

• Conditions: Lymphoma, Non-Hodgkin
• Interventions: Drug: immunochemotherapies

• Registration Number: NCT06170216
• Lead Sponsor: Fudan University

Brief Summary

Describe the application status of different immunochemotherapies in small B-cell non-Hodgkin lymphoma (iNHL), observe the therapeutic efficacy and safety of the treatment modalities.

Detailed Description

Evaluated the efficacy and safety of different immunochemotherapies in small B-cell non-Hodgkin lymphoma (iNHL)

Study Timeline

• Study Start: 2023-01-10
• Study First Submitted: 2023-11-29
• Study First Submitted QC: 2023-12-06
• Study First Posted: 2023-12-14
• Primary Completion: 2023-12-19
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-23
• Study Completion: 2026-01-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• Age ≥ 18 years old
• Initial or first recurrent iNHL confirmed by histopathology, including FL (1-3a), MZL, MCL;
• Sign an informed consent form;
• Researchers evaluate patients who can benefit from receiving immunochemotherapy.

Exclusion Criteria

• There are contraindications to any medication in the treatment plan;
• Pregnant or lactating women or male and female participants of childbearing age did not take contraceptive measures during the trial period and within 30 days after the last medication;
• Researchers believe that patients who are not suitable for enrollment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
iNHL	immunochemotherapies	Different immunochemotherapies in small B-cell non-Hodgkin lymphoma

Primary Outcome Measures

Name	Time	Method
ORR	up to 6 months	the ratio of numbers of patients with complete response and partial response to all the participants receiving treatment

Secondary Outcome Measures

Name	Time	Method
2-year event-free survival (EFS)	From date of patients sign informed consent until the date of first documented event, progression or date of death from any cause, whichever came first, assessed up to 2 years	the period from the date of patients sign informed consent to the observed event for any reason
2-year progression-free survival (PFS)	From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years	the period from the date of patients sign informed consent to the observed progression of the disease or the occurrence of death for any reason
overall survival	From date of patients sign informed consent until the date of death or the date of last follow-up time, whichever came first, assessed up to 2 years	time between the date of patients sign informed consent and the date of death or the date of last follow-up time
Hematology and non hematology toxicity	Throughout the treatment period，up to 6 months	number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China