EUCTR2017-001805-34-Outside-EU/EEA
Active, not recruiting
Phase 1
Phase II Study of Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia
ovartis Pharma K.K0 sites20 target enrollmentAugust 15, 2017
ConditionsPhiladelphia Chromosome Positive Acute Lymphocytic Leukemia (Ph+ALL)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
DrugsGlivec
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Philadelphia Chromosome Positive Acute Lymphocytic Leukemia (Ph+ALL)
- Sponsor
- ovartis Pharma K.K
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
Not specified
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