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

NCT ID: NCT00774332

Last Updated: 2008-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2009-12-31

Brief Summary

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

Detailed Description

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

Conditions

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Acute Lymphoblastic Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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CODOX-M

Cytoxan,Mesna,Adriamycin,Vincristine,Methotrexate,Leucovorin,Cytarabine

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cooperative Study Group A for Hematology

NETWORK

Sponsor Role lead

Responsible Party

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Yeungnam University College of Medicine

Principal Investigators

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Jung-Hee Lee, Doctor

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jung-Hee Lee, doctor

Role: CONTACT

Phone: 82-2-3010-5794

Email: [email protected]

Facility Contacts

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Jung-Hee Lee, Doctor

Role: primary

Other Identifiers

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C-011

Identifier Type: -

Identifier Source: org_study_id