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

Phase 1

• Conditions: Philadelphia Chromosome Positive Acute Lymphocytic Leukemia (Ph+ALL); Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2017-001805-34-Outside-EU/EEA
• Lead Sponsor: ovartis Pharma K.K

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-15
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Histologically confirmed diagnosis of Ph+ or bcr-abl + ALL. Refractory to or ineligible for initial remission induction therapy remission induction therapy
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

Are the trial subjects under 18? yes
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

to receive any hematopoietic stem cell transplantation within 6 weeks of the planned initiation of the study drug
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate efficacy (hematologic response) of STI571 in patients diagnosed Philadelphia-Positive Acute Lymphocytic Leukemia (Ph+ALL);Secondary Objective: To evaluate efficacy (response of duration, cytogenetic response) and safety of STI571 in patients diagnosed Philadelphia-Positive Acute Lymphocytic Leukemia (Ph+ALL) ;Primary end point(s): To evaluate hematologic response to STI571 in patients diagnosed Philadelphia-Positive Acute Lymphocytic Leukemia (Ph+ALL);Timepoint(s) of evaluation of this end point: Every 4 weeks

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: Every 4 weeks;Secondary end point(s): To valuate cytogenetic response, physical and laboratory evaluations, adverse event monitoring, and ECGs