Philadelphia Chromosome-positive acute lymphoblastic leukemia
Conditions
Interventions
The effect of imatinib mesylate monotherapy will be assessed using a molecular technique before the hematopoietic stem cell transplantation.
Sponsors
Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient with a diagnosis of Philadelphia chromosome-positive acute lymphoblastic leukemia. No previous treatment including chemotherapeutic agents and radiotherapy. The use of steroids or intrathecal tehrapy is accepted. ECOG performance status score should be 0-2. Adequate end organ function, defined as the following: total bilirubin < 2mg/dl, creatinin < 2mg/dl. Normal EKG. Patients or legal guardians must sign an informed consent and have been told of its possible benefits and toxic side effects. Patients or their guardians will be given a copy of the consent form.
Exclusion criteria
Exclusion criteria: Intracranial hemorrhage. Heart failure requiring treatment. Chronic renal failure. Active uncontrolled infections. Diabetes mellitus. Liver chirrhosis. Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent. Female patients who are pregnant or breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the efficacy of imatinib mesylate for children with Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) assessed by a molecular quantification technique. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the event-free survival for patients with Ph+ ALL assessed by a life table analysis, To evaluate the rate of patients who receive allogeneic stem cell transplantation (SCT) in the first complete remission (CR). To evaluate the safety of the regimen. | — |
Countries
Japan
Contacts
Public ContactTetsuya Takimoto
JPLSG Data Center
Outcome results
None listed