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Completed

NCT Number: NCT06170216

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

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.

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Key information

Conditions

Lymphoma, Non-Hodgkin Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

immunochemotherapies

Drug

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

Primary outcomes

  1. ORR

    Time frame: up to 6 months

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

Secondary outcomes

  1. 2-year progression-free survival (PFS)

    Time frame: 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

  2. 2-year event-free survival (EFS)

    Time frame: 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

  3. overall survival

    Time frame: 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

  4. Hematology and non hematology toxicity

    Time frame: Throughout the treatment period，up to 6 months

    number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2026
First posted
Dec 14, 2023
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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