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

Lymphoma, Non-Hodgkin Clinical Trial

Official title:

A Single-center, Non-interventionary Clinical Study Evaluating the Efficacy and Safety of Different Immunochemotherapies in Small B-cell Non-Hodgkin Lymphoma (iNHL)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06170216
• Other study ID #: iNHL-01
• Status: Active, not recruiting
• Start date: January 10, 2023
• Est. completion date: January 10, 2026

Study information

• Verified date: February 2024
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 220
• Est. completion date: January 10, 2026
• Est. primary completion date: December 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• immunochemotherapies
Observing different immunochemotherapies in small B-cell non-Hodgkin lymphoma (iNHL), which are chosen by investigators, such as RCHOP, BR, RCVP, etc.

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	the ratio of numbers of patients with complete response and partial response to all the participants receiving treatment	up to 6 months
Secondary	2-year progression-free survival (PFS)	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	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
Secondary	2-year event-free survival (EFS)	the period from the date of patients sign informed consent to the observed event for any reason	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
Secondary	overall survival	time between the date of patients sign informed consent and the date of death or the date of last follow-up time	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
Secondary	Hematology and non hematology toxicity	number of participants with treatment-related adverse events as assessed by CTCAE v5.0	Throughout the treatment period,up to 6 months