The Role of Consolidative Autologous Stem Cell Transplant... | NCT04489264

Studies
The Role of Consolidative Autologous Stem Cell Transplantation After First-line Therapy in Peripheral T Cell Lymphoma

NCT04489264

Sponsor

Peking University

Status

Unknown status

Last Update Posted

Dec 4, 2020Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Peripheral T Cell Lymphoma

Interventions

Transplant, Autologous

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

Dec 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 30, 2020Estimated

Primary Completion Date

Nov 30, 2023Estimated

Completion Date

Nov 30, 2025Estimated

First Submitted Date

Jul 23, 2020

First Submission Date that Met QC Criteria

Jul 24, 2020

First Posted Date

Jul 28, 2020Actual

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

Dec 2, 2020

Last Update Posted Date

Dec 4, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jun Zhu, Party secretary of Cancer Hospital of Peking University, Director of Internal Medicine, Peking UniversityPrincipal Investigator

Lead Sponsor

Peking UniversityOTHER

Collaborators

Not provided

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 role of autologous stem cell transplantation (ASCT) in the first remission (CR1 & PR1) of peripheral T-cell lymphomas (PTCLs) is not well defined. This study analyzed the impact of ASCT on the clinical outcomes of patients with newly diagnosed PTCL in CR1 and PR1.

Detailed Description

Not provided

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

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ASCT group		patients who achieved CR or PR after 6-8 cycles first-line therapy receive ASCT as consolidation therapy	Drug: Transplant, Autologous
Observation group		patients who achieved CR or PR after 6-8 cycles first-line therapy finish their therapy and go into follow-up

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transplant, Autologous	Drug	high dose chemotherapy followed by autologous stem cell transplantation	ASCT group

Measure	Description	Time Frame
PFS		2-year PFS

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with confirmed pathological diagnosis of aggressive PTCL
Age 18-65 years old
Achieving CR or PR after first-line therapy

Exclusion Criteria:

Subtypes with a more indolent course, including precursor T/natural killer neoplasms, T-cell large granular lymphocytic leukemia, mycosis fungoides other than transformed mycosis fungoides, Sézary syndrome, and primary cutaneous CD30-positive disorders.

Accepts Healthy Volunteers

Not provided

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

lymphoma patients in several hospitals in China

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jun Zhu, Dr.	Contact	+86-13910333346		zhu-jun2017@outlook.com

Overall Officials

Name	Affiliation	Role
Jun Zhu, Dr.	Peking University Cancer Hospital & Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Cancer Hospital	Recruiting	Beijing		100142	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016411	Lymphoma, T-Cell, Peripheral

Ancestor Terms

ID	Term
D016399	Lymphoma, T-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
D014182	Transplantation, Autologous

Ancestor Terms

ID	Term
D014180	Transplantation
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided