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

NCT06170216 | Active Not Recruiting

• 1 other identifier: iNHL-01
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma, Non-Hodgkin

Outcome Measures

Primary Outcomes (1)

• ORR

  the ratio of numbers of patients with complete response and partial response to all the participants receiving treatment

  up to 6 months

Secondary Outcomes (4)

• 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

• 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

• 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

• Hematology and non hematology toxicity

  Throughout the treatment period，up to 6 months

Study Arms (1)

iNHL

Different immunochemotherapies in small B-cell non-Hodgkin lymphoma

Drug: immunochemotherapies

Interventions

immunochemotherapies DRUG

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

iNHL

Eligibility Criteria

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

Study Population

Eligibale patients who ≥ 18 years old, Initial or first recurrent iNHL, with no contraindications to any medication in the treatment plan are enrolled. They will sign an informed consent form. Pregnant or lactating women were excluded. And patients who may not benefit from receiving immunochemotherapy evaluated by researchers are also excluded.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 14, 2023
• Study Start: January 10, 2023
• Primary Completion: December 19, 2023
• Study Completion: January 10, 2026
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

CN (1)