Efficacy Study of Imatinib Mesylate to Treat Philadelphia-Positive Acute Lymphocytic Leukemia

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Novartis

Status and phase

Completed
Phase 2

Conditions

Philadelphia Chromosome Positive Acute Lymphocytic Leukemia

Treatments

Drug: Imatinib Mesylate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00154349
CSTI571I1203

Details and patient eligibility

About

The objective of this study is to determine the efficacy and safety of imatinib mesylate in patients diagnosed as having Philadelphia chromosome positive acute lymphocytic leukemia (ALL).

Enrollment

8 patients

Sex

All

Ages

15+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

8 participants in 1 patient group

imatinib mesylate
Experimental group
Treatment:
Drug: Imatinib Mesylate

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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