Clinical trial · Interventional
STI 571 (GLIVEC) in the Treatment of Adult Acute Lymphoblastic Leukemia
STI 571 (GLIVEC) in the Treatment of Philadelphia-chromosome Positive and/or BCR/ABL Rearranged Adult Acute Lymphoblastic Leukemia. GIMEMA LAL 0201.
- 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)
This proposal, developed in the framework of the GIMEMA, will permit: * to evaluate the activity and toxicity of imatinib in the treatment of Ph+ acute lymphoblastic leukemia; * to evaluate the molecular response to the treatment, and to monitor the molecular status of remission in all cases achieving or not a molecular response. The GIMEMA has activated a network to centralize all biological samples (bone marrow and peripheral blood) at diagnosis from all new ALL patients. This will permit to identify, in particular, Ph + and/or BCR/ABL + cases within 5 days from diagnosis, thus permitting to treat these patients according to different programs on the basis of the presence of Ph chromosome.
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 |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imatinib | Drug | Imatinib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- for Study A, the primary endpoint for activity is overall CMR rate
- timeFrame
- after 6 months of imatinib treatment
- measure
- for Study B, the primary endpoint for activity is overall CHR (+/- CMR) rate .
- timeFrame
- after induction treatment
Secondary outcomes (2)
- measure
- complete hematological or molecular remission duration
- timeFrame
- at study end
- measure
- overall survival.
- timeFrame
- at study end
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with Ph +ve and/or BCR/ABL +ve ALL, either in 1st CHR (independently from the molecular status) for study A, or at diagnosis and untreated for study B; * Age \>18 years and \<60 for study A, \>60 for study B; * Written voluntary informed consent. Exclusion Criteria: * Patients of childbearing potential without a negative pregnancy test prior to the initiation of study. Barrier contraceptive precautions are to be used throughout the trial in both sexes; * Pretreatment with steroids for more than 10 days in study B; * Serum bilirubin and creatinine values \>3 the upper limit of normal range; * SGOT and SGPT values \>3 the upper limit of the normal range; * Patients who had received any other investigational agent within 4 weeks before the enrollment; * Patients with cardiovascular diseases grade \>3 according to the New York Heart Association (see Appendix 1); * Patients with a history of non compliance to medical regimen or who are considered potentially unreliable; * Patients with moderate/severe mood or psychiatric disorders; * Concomitant neoplasia.
References
Publications (1)
- RESULTVignetti M, Fazi P, Cimino G, Martinelli G, Di Raimondo F, Ferrara F, Meloni G, Ambrosetti A, Quarta G, Pagano L, Rege-Cambrin G, Elia L, Bertieri R, Annino L, Foa R, Baccarani M, Mandelli F. Imatinib plus steroids induces complete remissions and prolonged survival in elderly Philadelphia chromosome-positive patients with acute lymphoblastic leukemia without additional chemotherapy: results of the Gruppo Italiano Malattie Ematologiche dell'Adulto (GIMEMA) LAL0201-B protocol. Blood. 2007 May 1;109(9):3676-8. doi: 10.1182/blood-2006-10-052746. Epub 2007 Jan 9. PMID 17213285