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Phase II Study of Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia


Phase 2
15 Years
N/A
Not Enrolling
Both
Philadelphia Chromosome Positive Acute Lymphocytic Leukemia

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Trial Information

Phase II Study of Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia


Inclusion Criteria:



- Patients with histologically confirmed diagnosis of ALL.

- Patients confirmed to be Ph chromosome positive or bcr-abl gene positive.

- Patients in relapse

- Patients refractory to initial remission induction therapy

- Patients ineligible for initial remission induction therapy

- Patients with an ECOG Performance Status Score from 0 to 2

- Serum creatinine concentration of not more than 2 × the upper limit of the normal
range (ULN)

- AST (SGOT) and ALT (SGPT) of not more than 3 × ULN. In patients with hepatic
dysfunction from leukemic involvement, AST (SGOT) and ALT (SGPT) should be not more
than 5 × ULN

- Serum bilirubin level not more than 3 × ULN

Exclusion Criteria:

- Patients with findings indicative of leukemic involvement of the central nervous
system

- Patients with any serious concomitant medical condition (e.g., poorly controllable
infection, interstitial pneumonia, pulmonary fibrosis, congestive cardiac failure,
poorly controlled diabetes mellitus, mental disorder)

- Patients expected to receive any hematopoietic stem cell transplantation within 6
weeks of the planned initiation of the study drug

- Patients having received any hematopoietic stem cell transplantation who have a Grade
3 or 4 GVHD.

Other protocol-defined inclusion/exclusion criteria may apply.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

3 month hematological response rate

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

CSTI571I1203

NCT ID:

NCT00154349

Start Date:

October 2003

Completion Date:

Related Keywords:

  • Philadelphia Chromosome Positive Acute Lymphocytic Leukemia
  • Ph+ALL
  • imatinib mesylate
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Philadelphia Chromosome

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