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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00154349
First received: September 9, 2005
Last updated: March 9, 2011
Last verified: March 2011
History of Changes
  Purpose

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).


Condition Intervention Phase
Philadelphia Chromosome Positive Acute Lymphocytic Leukemia
 Drug: Imatinib Mesylate
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 3 month hematological response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of hematological response [ Designated as safety issue: No ]
  • Survival [ Designated as safety issue: No ]
  • Cytogenetic response in every 3 months [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: October 2003
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: imatinib mesylate Drug: Imatinib Mesylate
Other Names:
  • STI571,
  • Glivec,
  • Gleevec

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00154349

Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00154349     History of Changes
Other Study ID Numbers: CSTI571I1203
Study First Received: September 9, 2005
Last Updated: March 9, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:
Ph+ALL
imatinib mesylate

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Philadelphia Chromosome
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Translocation, Genetic
Chromosome Aberrations
Pathologic Processes
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013