Chidamide in Patients With Recurrent and Refractory Diffu... | NCT05690191

Studies
Chidamide in Patients With Recurrent and Refractory Diffuse Large b

NCT05690191

Sponsor

Second Affiliated Hospital of Soochow University

Status

Enrolling by invitation

Last Update Posted

Jan 19, 2023Actual

Enrollment

169Estimated

Phase

Not provided

Conditions

Diffuse Large B-cell Lymphoma

Interventions

Chidamide
Lenalidomide
Rituximab

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2021Actual

Primary Completion Date

Aug 1, 2026Estimated

Completion Date

Aug 1, 2026Estimated

First Submitted Date

Dec 5, 2022

First Submission Date that Met QC Criteria

Jan 9, 2023

First Posted Date

Jan 19, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2023

Last Update Posted Date

Jan 19, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

169Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Chidamide in combination with rituximab and lenalidomide		Chidamide tablets: 20mg orally, twice a week (at least 3 days between doses); Rituximab injection: 375mg/m2 intravenously, once every 4 weeks (Q4w), on the first day of each cycle; Lenalidomide capsule: 25mg orally, once before going to bed every night, from day 1 to day 21 of each cycle	Drug: Chidamide Drug: Lenalidomide Drug: Rituximab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chidamide	Drug	Chidamide tablets: 20mg orally, twice a week (at least 3 days between doses	Chidamide in combination with rituximab and lenalidomide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective response rate	Objective response rates assessed by the investigator	30 months

Secondary Outcomes

Measure	Description	Time Frame
Adverse Events	Incidence of adverse events	30 months

Other Outcomes

Measure	Description	Time Frame
Complete response rate	Complete response rate	30 months
Progression-free survival	Progression-free survival	30 months

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Diffuse Large B-cell Lymphoma

Sampling Method

Probability Sample

Name	Affiliation	Role
Bingzong LI	Second Affiliated Hospital of Soochow University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Second Affiliated Hospital of Soochow University		Suzhou	Jiangsu		China

Condition Browse Module

MeSH Terms

ID	Term
D016403	Lymphoma, Large B-Cell, Diffuse

Ancestor Terms

ID	Term
D016393	Lymphoma, B-Cell
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C547816	N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide
D000077269	Lenalidomide
D000069283	Rituximab

Ancestor Terms

ID	Term
D010797	Phthalimides
D010795	Phthalic Acids
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids

Browse Leaves

Not provided

Browse Branches

Not provided