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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 (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00154349
First received: September 9, 2005
Last updated: February 21, 2017
Last verified: February 2017
  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
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Phase II Study of Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • 3 month hematological response rate

Secondary Outcome Measures:
  • Duration of hematological response
  • Survival
  • Cytogenetic response in every 3 months

Enrollment: 8
Study Start Date: October 2003
Study Completion Date: February 2007
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   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00154349     History of Changes
Other Study ID Numbers: CSTI571I1203
Study First Received: September 9, 2005
Last Updated: February 21, 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Ph+ALL
imatinib mesylate

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

ClinicalTrials.gov processed this record on May 25, 2017