Clinical trial · Interventional
Efficacy Study of Imatinib Mesylate to Treat Philadelphia-Positive Acute Lymphocytic Leukemia
Phase II Study of Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia
NCT00154349CI-TRIAL-00026131completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Philadelphia Chromosome Positive Acute Lymphocytic Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imatinib Mesylate | Drug | Imatinib Mesylate | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- imatinib mesylate
- interventionNames
- Drug: Imatinib Mesylate
Primary outcomes (1)
- measure
- 3 month hematological response rate
Secondary outcomes (3)
- measure
- Duration of hematological response
- measure
- Survival
- measure
- Cytogenetic response in every 3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.