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

Philadelphia Chromosome Positive Acute Lymphocytic Leukemia Clinical Trial

Official title:

Phase II Study of Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00154349
• Other study ID #: CSTI571I1203
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: February 21, 2017
• Start date: October 2003
• Est. completion date: February 2007

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Philadelphia Chromosome
• Philadelphia Chromosome Positive Acute Lymphocytic Leukemia
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Imatinib Mesylate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3 month hematological response rate
Secondary	Duration of hematological response
Secondary	Survival
Secondary	Cytogenetic response in every 3 months

External Links

•   Results for CSTI571I1203 from the Novartis Cliniccal Trials website