Clinical trial · Interventional
Study Comparing Imatinib With Chemotherapy as Induction in Elderly Patients With Philadelphia Positive Acute Lymphoblastic Leukemia (ALL)
A Randomized, Multicenter Open Label Phase II Study to Determine the Safety and Efficacy of Induction Therapy With Imatinib in Comparison With Standard Induction Chemotherapy in Elderly (> 55 Years) Patients With Ph Positive Acute Lymphoblastic Leukemia (ALL)
- 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 aims of the study are to determine whether single agent imatinib (STI571; Glivec) is more effective as up-front remission induction therapy than conventional multi-agent induction chemotherapy for elderly patients with Philadelphia positive (Ph+)ALL, whether this treatment is better tolerated, and whether subsequent combination therapy with imatinib and chemotherapy of approximately a 1 year duration is tolerable and effective with respect to maintaining remissions.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoid Blastic Phase of Chronic Myeloid Leukemia | — | UNRESOLVED | — |
| Philadelphia Positive Acute Lymphoblastic Leukemia | B Acute Lymphoblastic Leukemia with t(9;22)(q34.1;q11.2); BCR-ABL1 | ALIAS | 0.90 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AraC (intrathecal) | Drug | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cytosine arabinoside | Drug | Cytarabine | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| dexamethasone (intrathecal) | Drug | Dexamethasone | ALIAS |
| idarubicin | Drug | Idarubicin | ALIAS |
| imatinib | Drug | Imatinib | ALIAS |
| methotrexate (intrathecal) | Drug | Methotrexate | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Remission rate after induction therapy
Secondary outcomes (9)
- measure
- Mortality rate during induction
- measure
- Severe adverse events during induction
- measure
- Efficacy of salvage therapy after crossover
- measure
- Levels of minimal residual disease
- measure
- Incidence of relapse
- measure
- Remission duration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 56 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female patients * Age \> 55 years (biological age) * Diagnosis of Ph1 chromosome-positive ALL (pre-B, common- or pre-pre-B ALL) * Newly diagnosed, lymphoid blast crisis of chronic myeloid leukemia * Only pre-phase chemotherapy prior to study start * World Health Organization (WHO) status 0, 1 or 2 * Voluntary written informed consent Exclusion Criteria: * Creatinine levels more than 2 x the upper limit of normal (ULN) * Total serum bilirubin more than 1.5 x the ULN * AST (SGOT) or ALT (SGPT) more than 5 x the ULN * Any other prior antineoplastic treatment except for pre-phase chemotherapy * Active central nervous system (CNS) leukemia * New York Heart Association (NYHA) grade 3/4 cardiac disease * Active severe infection * Serious concomitant medical condition * Patients with a history of non-compliance to medical regimens
References
Publications (0)
Data not yet available