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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

September 9, 2005
March 9, 2011
October 2003
February 2007   (final data collection date for primary outcome measure)
3 month hematological response rate [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00154349 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
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Efficacy Study of Imatinib Mesylate to Treat Philadelphia-Positive Acute Lymphocytic Leukemia
Phase II Study of Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia

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).

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Philadelphia Chromosome Positive Acute Lymphocytic Leukemia
Drug: Imatinib Mesylate
Other Names:
  • STI571,
  • Glivec,
  • Gleevec
Experimental: imatinib mesylate
Intervention: Drug: Imatinib Mesylate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
Not Provided
February 2007   (final data collection date for primary outcome measure)

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.

Both
15 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00154349
CSTI571I1203
Not Provided
External Affairs, Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP