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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00154349

Enrollment

Registered

2005-09-12

Start date

2003-10-31

Completion date

2007-02-28

Last updated

2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Philadelphia Chromosome Positive Acute Lymphocytic Leukemia

Keywords

Ph+ALL, imatinib mesylate

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).

Interventions

DRUGImatinib Mesylate

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
3 month hematological response rate	—

Secondary

Measure	Time frame
Duration of hematological response	—
Survival	—
Cytogenetic response in every 3 months	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026