Clinical trial · Interventional
Imatinib Mesylate With Vincristine and Dexamethasone in Acute Lymphoblastic Leukemias With BCR-ABL Positive
Study to Evaluate Efficacy and Safety of Glivec® in Combination With Vincristine and Dexamethasone in Patients With Lymphoid Blast Crisis CML or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia in Relapse or Refractory
- 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)
Patients not previously exposed to imatinib and with resistant or refractory Ph+ ALL, lymphoid blast crisis chronic myelogenous leukaemia (LBC CML) or with de novo Ph+ ALL and aged over 55y were eligible in the study. The DIV regimen consisted in one IV injection of vincristine 2 mg combined with 2 days of dexamethasone 40 mg PO repeated weekly for 4 weeks as induction and then monthly for 4 months as consolidation. Imatinib was administered at 800 mg per day during the induction period and at 600 mg/d continuously during consolidation. Patients in CR not eligible for HSCT were allocated to maintenance therapy consisting in weekly SC injection of Pegasys 45 µg and continuous administration of imatinib 400 mg per day for 2 years.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Blast Crisis | Blast Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Leukemia, Lymphocytic, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Leukemia, Myeloid, Chronic | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Philadelphia Chromosome | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
| Interferon | Drug | — | UNRESOLVED |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- imatinib in combination with chemotherapy by vincristin and dexamethasone
- interventionNames
- Drug: Imatinib mesylate
- Drug: Interferon
- Drug: Vincristine
- Drug: Dexamethasone
Primary outcomes (1)
- measure
- To determine the rate of hematological response induced by Gleevec™ combined with vincristine and dexamethasone
- timeFrame
- After 35 days or 56 days of induction
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female subjects over 18 years, * Poor prognosis BCR-ABL transcript-positive acute lymphoblastic leukemia (refractory or relapsing Ph+ ALL, BP lymphoid CML, BP lymphoid CML in relapse) Exclusion Criteria: * Pregnant female, * Blastic involvement of the CNS, * Participation in an investigational agent trial within 4 weeks, * High dose therapy within 4 weeks, * Gleevec administration within 3 months, * Transaminases grade 3 or 4 elevation.
References
Publications (0)
Data not yet available