A Phase II Study of CODOX-M/ IVAC in Relapsed/Refractory ALL | NCT00774332

Studies
A Phase II Study of CODOX-M/ IVAC in Relapsed/Refractory ALL

NCT00774332

Sponsor

Cooperative Study Group A for Hematology

Status

Unknown status

Last Update Posted

Oct 17, 2008Estimated

Enrollment

37Estimated

Phase

Phase 2

Conditions

Acute Lymphoblastic Leukemia

Interventions

CODOX-M

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

Oct 2008

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

Jun 2006

Primary Completion Date

Jun 2006Actual

Completion Date

Dec 2009Estimated

First Submitted Date

Oct 15, 2008

First Submission Date that Met QC Criteria

Oct 15, 2008

First Posted Date

Oct 17, 2008Estimated

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

Oct 15, 2008

Last Update Posted Date

Oct 17, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

A Phase II Study of CODOX-M/ IVAC in Relapsed/Refractory ALL

Detailed Description

The feasibility will be evaluated in terms of complete remission rate, duration of complete remission, disease-free survival, overall survival, and toxicities.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

37Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CODOX-M	Drug	Cytoxan,Mesna,Adriamycin,Vincristine,Methotrexate,Leucovorin,Cytarabine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Duration of complete remission, disease-free survival, overall survival, toxicities		2009

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with relapsed/resistant acute lymphoblastic leukemia
Patients must be between 15 and 65 years of age.
Estimated life expectancy of more than 3 months
ECOG performance status of 2 or lower, Karnofsky scale > 60 (see appendix I)
Adequate cardiac function (EF>45%) on echocardiogram or MUGA scan
Adequate kidney function (estimated Ccr >50 ml/min)

Exclusion Criteria:

Patients with CNS involvement of leukemic blasts will not be excluded.
Patients with extramedullary relapse(s) only will be excluded.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jung-Hee Lee, doctor	Contact	82-2-3010-5794		jhleecr@amc.seoul.kr

Overall Officials

Name	Affiliation	Role
Jung-Hee Lee, Doctor	Asan Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Center	Recruiting	Seoul			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

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C039323	ANAVACYM protocol

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided