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


Phase 2
15 Years
65 Years
Open (Enrolling)
Both
Acute Lymphoblastic Leukemia

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Trial Information

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


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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

2009

Safety Issue:

Yes

Principal Investigator

Jung-Hee Lee, Doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center

Authority:

Korea: Food and Drug Administration

Study ID:

C-011

NCT ID:

NCT00774332

Start Date:

June 2006

Completion Date:

December 2009

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

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