High-dose Etoposide Could Discriminate Patients With Refr... | NCT03130582

Studies
High-dose Etoposide Could Discriminate Patients With Refractory/Relapsed Lymphoma Benefit From APBSCT

NCT03130582

Sponsor

Yang Jun

Status

Completed

Last Update Posted

Apr 28, 2017Actual

Enrollment

88Actual

Phase

Not provided

Conditions

Lymphoma

Interventions

high-dose etoposide

Countries

Not provided

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

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2005Actual

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2016Actual

First Submitted Date

Apr 22, 2017

First Submission Date that Met QC Criteria

Apr 22, 2017

First Posted Date

Apr 26, 2017Actual

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

Apr 26, 2017

Last Update Posted Date

Apr 28, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yang Jun, Principal Investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineSponsor-Investigator

Lead Sponsor

Yang JunOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

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

patients with refractory /relapsed lymphoma received high-dose etoposide for hematopoietic stem cell (HSC) mobilization.All patients received high-dose etoposide 20-25 mg/kg/d intravenously for two consecutive days followed by rhG-CSF10ug/kg/day subcutaneously at 48 hours after chemotherapy; rhG-CSF was continued until the end of harvesting for HSCs/HPCs. Peripheral blood counts were performed daily for all patients following the initiating of rhG-CSF. Leukapheresis was performed when peripheral blood white blood count exceeded 4×109/L with blood cell The harvested cells reached at least 2*108/kg for mononuclear cells and/or 2*106/kg for CD34+ cells with once to twice leukapheresis. The final product was kept frozen in liquid nitrogen.Auto-PBSCT

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

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

88Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Disease status at mobilization PR			Drug: high-dose etoposide
Disease status at mobilization PD			Drug: high-dose etoposide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
high-dose etoposide	Drug	an epipodophyllotoxin, is one of the most common chemotherapy agents for lymphoma without reciprocal resistance with other kinds of agents.	Disease status at mobilization PD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
death	death	10 years
CR	Complete response	10 years
relapse	relapse	10 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

relapsed/refractory lymphoma ,siut APBSCT

Exclusion Criteria:

bone marrow without involvement by lymphoma cells

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

patients with refractory/relapsed lymphoma

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D008223	Lymphoma

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005047	Etoposide

Ancestor Terms

ID	Term
D011034	Podophyllotoxin
D013764	Tetrahydronaphthalenes
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons

Browse Leaves

Not provided

Browse Branches

Not provided