Hyper-CVAD Treatment in Lymphoblastic Lymphoma | NCT01813344

Studies
Hyper-CVAD Treatment in Lymphoblastic Lymphoma

NCT01813344

Sponsor

Ajou University School of Medicine

Status

Unknown status

Last Update Posted

Mar 19, 2013Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Lymphoblastic Lymphoma

Interventions

Not provided

Countries

South Korea

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

Mar 2013

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

Jan 2012

Primary Completion Date

Jun 2013Estimated

Completion Date

Not provided

First Submitted Date

Mar 13, 2013

First Submission Date that Met QC Criteria

Mar 14, 2013

First Posted Date

Mar 19, 2013Estimated

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

Mar 14, 2013

Last Update Posted Date

Mar 19, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Seong Hyun Jeong, Assistant professor, Ajou University School of MedicinePrincipal Investigator

Lead Sponsor

Ajou University School of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Treatment outcomes of lymphoblastic lymphoma (LBL) have improved by the use of the regimens for acute lymphoblastic leukemia. Hyper-CVAD is one of the most effective treatments with high remission rate in acute lymphoblastic leukemia (ALL) and LBL. However, the treatment outcome of hyper-CVAD in LBL has reported only in small number of patients from single institution. The investigators conducted this study to evaluate the hyper-CVAD regimen based treatment in LBL.

Detailed Description

We will analyze treatment outcome of lymphoblastic lymphoma patients treated with hyper-CVAD regimen from 13 institutions in Korea. In all patients, hyper-CVAD was initial treatment. After achievement of response, patients either underwent hematopoietic stem cell transplantation (HSCT) or consolidation with hyper-CVAD.

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

50Estimated

Measure	Description	Time Frame
Overall survival		3-year
Progression free survival		3-year

Measure	Description	Time Frame
Response Rate		24 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age over 18 at diagnosis
Pathologically proven lymphoblastic lymphoma

Exclusion Criteria:

proven HIV infection
pretreatment with other regimens

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

Adult lymphoblast lymphoma patients treated with hyper-CVAD regimen in Korea

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Seong Hyun Jeong, MD	Contact	+82-31-219-5989		seonghyunmd@naver.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ajou Universtiy School of Medicine	Recruiting	Suwon	Kyeonggi	443-721	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma

Ancestor Terms

ID	Term
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

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Browse Branches

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