A Randomized Clinical Trial Comparing Chi-BEAM With BEAM... | NCT05931263

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2023Actual

Primary Completion Date

Feb 2026Estimated

Completion Date

Feb 2028Estimated

First Submitted Date

Jun 27, 2023

First Submission Date that Met QC Criteria

Jun 27, 2023

First Posted Date

Jul 5, 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

Jun 27, 2023

Last Update Posted Date

Jul 5, 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

The goal of this clinical trial is to compare Chi-BEAM With BEAM Regimen Combined With ASCT for the Treatment of ND PTCL.

The main question it aims to answer are:

•Whether Chi-BEAM improves patient survival compared to BEAM group Participants will be given BEAM or Chi-BEAM before ASCT. Researchers will compare the efficacy and safety of the two groups.

Detailed Description

This is a prospective, multicenter, randomized controlled, open trial. The primary endpoint was 2-year PFS The secondary endpoint was： 2-year overall survival (OS). CR rate at 3 months post-transplant evaluation Hematopoietic reconstitution time Non-recurrent mortality (NRM)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

104Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
C-BEAM	Experimental	Chidemide，carmustine, etoposide, cytarabine, and melphalan plus autologous stem cell transplantation	Drug: C-BEAM Regimen
BEAM	Sham Comparator	carmustine, etoposide, cytarabine, and melphalan plus autologous stem cell transplantation	Drug: BEAM Regimen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
C-BEAM Regimen	Drug	Chidemide，carmustine, etoposide, cytarabine, and melphalan	C-BEAM

Measure	Description	Time Frame
2-y PFS	2-year PFS	2 years

Measure	Description	Time Frame
2-year OS		2 years
CR rate at 3 months post-transplant evalutation		2 years
hematopoietic reconstitution time

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pathologically diagnosed patients with newly treated PTCL (including NT/ K-cell lymphoma), except for ALK (+), have CR or PR after first-line treatment;
Renal function needs to be satisfied: creatinine clearance ≥80ml/min, creatinine less than 160μmol/L; Liver function requirements: ALT and AST≤2 times the upper limit of normal; Total bilirubin ≤2 times the upper limit of normal; Lung function should meet: FEV1, FVC, DLCO≥50% predictive value; Cardiac function must be satisfied: left ventricular ejection fraction ≥50%, asymptomatic arrhythmia.
Age between 18 and 65 years old, male and female;
ECOG physical strength score 0-1;
Neutrophil absolute value ≥1.5×109/L, platelets ≥ 70×109/L, hemoglobin ≥ 90g/L; Number of CD34+ cells ≥ 2.0×106/kg body weight;
Expected survival time ≥3 months;
Voluntarily sign written informed consent.

Exclusion Criteria:

Lymphoma involving the central nervous system
Active hepatitis B or C virus infection;
Active infection;
HIV infected persons;
Evidence of cirrhosis or liver fibrosis;
Ecg showed QTc > 500ms;
Persons with mental disabilities/unable to obtain informed consent;
Patients with drug or chronic alcohol abuse that may affect the evaluation of study results;
Pregnant and lactating women and women of childbearing age who do not want to take contraceptive measures;
The researcher determines that it is not suitable to participate in this study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
wei xu	Contact	86-25-68302182		xuwei10000@hotmail.com

Overall Officials

Name	Affiliation	Role
wei xu	: China, Jiangsu Hematological Department, People's Hospital of Jiangsu Province	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hematological Department, People's Hospital of Jiangsu Province	Recruiting	Nanjing	Jiangsu	210029	China