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

NCT00154349 | Completed Phase 2

• 1 other identifier: CSTI571I1203
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Philadelphia Chromosome Positive Acute Lymphocytic Leukemia

Keywords

Ph+ALL; imatinib mesylate

Outcome Measures

Primary Outcomes (1)

• 3 month hematological response rate

Secondary Outcomes (3)

• Duration of hematological response

• Survival

• Cytogenetic response in every 3 months

Study Arms (1)

imatinib mesylate

EXPERIMENTAL

Drug: Imatinib Mesylate

Interventions

Imatinib Mesylate DRUG

Also known as: STI571,, Glivec,, Gleevec

imatinib mesylate

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Interventions

Imatinib Mesylate

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 12, 2005
• Study Start: October 1, 2003
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: February 23, 2017

Record last verified: 2017-02