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Status unknownNCT00774332Updated Oct 17, 2008

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

A Phase 2 interventional study of CODOX-M in Acute Lymphoblastic Leukemia, sponsored by Cooperative Study Group A for Hematology. Status unknown at 1 site in Korea, Republic of. Open to participants aged 15 Years to 65 Years. Per ClinicalTrials.gov, last updated 2008-10-17.

Sponsored by Cooperative Study Group A for Hematology · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2008), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
37
Allocation
Not applicable
Ages
15 Years to 65 Years
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Acute Lymphoblastic Leukemia
03

In context

Precursor Cell Lymphoblastic Leukemia-Lymphoma

2,061 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 490 are open to participants now.

This study's planned enrollment of 37 is close to the median of 40 across 1,653 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.

Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →

Lead sponsor

Cooperative Study Group A for Hematology is the lead sponsor of 18 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Patients with CNS involvement of leukemic blasts will not be excluded.
  • Patients with extramedullary relapse(s) only will be excluded.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
37 participants (estimated)

Interventions

  • DrugCODOX-M

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

06

What researchers measure

Primary outcomes

  1. Duration of complete remission, disease-free survival, overall survival, toxicities

    Time frame: 2009

07

Study locations

1 of 1 sites recruiting
  • Asan Medical Center
    Seoul, Korea, Republic of
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00774332
Lead sponsor
Cooperative Study Group A for Hematology
First posted
Oct 17, 2008
Start date
Jun 2006
Primary completion
Jun 2006
Completion
Dec 2009 (estimated)
Last update
Oct 17, 2008

Study contacts

Jung-Hee Lee, doctor
Contact
jhleecr@amc.seoul.kr
82-2-3010-5794
Jung-Hee Lee, Doctor
principal investigator · Asan Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.

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Discussion

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