NCT00774332

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 15, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2008

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

October 17, 2008

Status Verified

October 1, 2008

Enrollment Period

Same day

First QC Date

October 15, 2008

Last Update Submit

October 15, 2008

Conditions

Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

  • Duration of complete remission, disease-free survival, overall survival, toxicities

    2009

Interventions

CODOX-MDRUG

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

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

ANAVACYM protocol

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Jung-Hee Lee, Doctor

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jung-Hee Lee, doctor

CONTACT

82-2-3010-5794jhleecr@amc.seoul.kr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK

Study Record Dates

First Submitted

October 15, 2008

First Posted

October 17, 2008

Study Start

June 1, 2006

Primary Completion

June 1, 2006

Study Completion

December 1, 2009

Last Updated

October 17, 2008

Record last verified: 2008-10

Locations

KR(1)