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Enrolling by Invitation

NCT Number: NCT05690191

Chidamide in Patients With Recurrent and Refractory Diffuse Large b

A Multicenter, Prospective, Observational Clinical Protocol for Chidamide in Combination With Rituximab and Lenalidomide (cR2) in Real-world Practice in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

About this study

This is a prospective, multicenter, observational investigator-initiated clinical study. The subjects were adults (18 years of age and older) diagnosed with relapsed/refractory diffuse large B-cell lymphoma who will begin cR2 therapy at the time of enrollment. Patients were required to complete a visit every 4 weeks, lasting 24 weeks from the first dosing of the study protocol. The first visit was considered an enrollment visit. The specific dosage of cR2 will be determined according to the standard clinical practice of the treating physician. Participation in the study did not affect treatment decisions. Patients who could not continue with the cR2 regimen would terminate the visit early and then withdraw from the study. According to the data collected from the experiment, the safety and effectiveness of the research scheme were analyzed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The decision of treating physicians to make cR2 regimen was not related to whether they participated in the study or not;
  • Age 18 and above, no gender limitation;
  • Patients with pathologically confirmed diffuse large B-cell lymphoma (DLBCL) who have relapsed or failed to respond to at least one systemic therapy;
  • Have at least one measurable lesion: any length of lymph node lesion ≥1.5cm or any length of extrinsic lesion > 1cm;
  • The serum pregnancy test of female subjects of childbearing age was negative;
  • Understand the test procedure and content, and sign the informed consent voluntarily.

Exclusion criteria

  • The decision of treating physicians to make cR2 regimen was not related to whether they participated in the study or not;
  • Age 18 and above, no gender limitation;
  • Patients with pathologically confirmed diffuse large B-cell lymphoma (DLBCL) who have relapsed or failed to respond to at least one systemic therapy;
  • Have at least one measurable lesion: any length of lymph node lesion ≥1.5cm or any length of extrinsic lesion > 1cm;
  • The serum pregnancy test of female subjects of childbearing age was negative;
  • Understand the test procedure and content, and sign the informed consent voluntarily.

Treatment and study plan

Chidamide

Drug

Chidamide tablets: 20mg orally, twice a week (at least 3 days between doses

Lenalidomide

Drug

Lenalidomide capsule: 25mg orally, once before going to bed every night, from day 1 to day 21 of each cycle

Rituximab

Drug

Rituximab injection: 375mg/m2 intravenously, once every 4 weeks (Q4w), on the first day of each cycle

Primary outcomes

  1. Objective response rate

    Time frame: 30 months

    Objective response rates assessed by the investigator

Secondary outcomes

  1. Adverse Events

    Time frame: 30 months

    Incidence of adverse events

Other outcomes

  1. Complete response rate

    Time frame: 30 months

    Complete response rate

  2. Progression-free survival

    Time frame: 30 months

    Progression-free survival

  3. Overall survival time

    Time frame: 30 months

    Overall survival time

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Soochow University

Other

Registry information

Official study title

A Multicenter, Prospective, Observational Clinical Protocol for Chidamide in Combination With Rituximab and Lenalidomide (cR2) in Real-world Practice in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 19, 2023
Registry last updated
Jan 19, 2023

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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