Clinical trial · Interventional
Glivec in Ph Positive Lymphoblastic Leukemia
Positive Ph Acute Lymphoblastic Leucemia With Intensive Induction Chemotherapy and Glivec, Before and After the Hematopoetic Progenitor Transplant
NCT00388895CI-TRIAL-00001797completedPhase 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)
% positive Ph LLA with RC alter the Glivec and induction chemotherapy treatment
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 |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Cromosome Philadelphia Positive | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemotherapy | Drug | Chemotherapy | ALIAS |
| Glivec | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- % positive Ph LLA with RC alter the Glivec and induction chemotherapy treatment.
- measure
- Discover if is possible to treat patients with Glivec plus Standard consolidation treatment.
- measure
- Discover the Glivec effect over ERM during consolidation treatment and alter transplant
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * New diagnosis LLA Ph+ (BCR/ABL) patients ≤ 65 years old * Fertile age women must do a pregnancy test in the 7 days previous at the beginning of clinical trial medication * Performance status 0-2 (Appendix B); Is allowed performance status \> 2 because of LLA * Patients without organ alteration: hepatic function: global bilirubin, AST, ALT, gamma-GT and alkaline phosphatase less than 2 times LSN; renal function: Creatinine \< 1,5 mg/dl o Clearance creatinine \> 60 ml/min; anormal renal function caused by LLA ; normal heart function (Appendix B): FEV \> 50%; No Chronic respiratory illness. If the anormal values are secondary of the experimental illness the investigator can decide himself if the patient can be included at the clinical trial. * Negative HIV serology * Written, oral or with witness informed consent. In patients \< 18 years old must be signed written and legal representative informed consent. * No experimental chemotherapy or other experimental treatment. Allowed to begin induction chemotherapy from the diagnosis to confirm Ph. No major surgical process in the previous 14 days of the treatment Start. Exclusion Criteria: * Other LLA variability * Previous history of coronary valvular, hypertensive cardiopathy illness * Chronic hepatic illness * Chronic respiratory insufficiency * Renal insufficiency not caused by LLA * Severe neurological problems not caused by LLA * Severe affection of the performance status (grade 3-4 OMS gradation) not caused by LLA * Pregnancy and women * Blastic crisis LMC
References
Publications (13)
- BACKGROUNDSchrappe M, Reiter A, Zimmermann M, Harbott J, Ludwig WD, Henze G, Gadner H, Odenwald E, Riehm H. Long-term results of four consecutive trials in childhood ALL performed by the ALL-BFM study group from 1981 to 1995. Berlin-Frankfurt-Munster. Leukemia. 2000 Dec;14(12):2205-22. doi: 10.1038/sj.leu.2401973. PMID 11187912
- BACKGROUNDThomas X, Thiebaut A, Olteanu N, Danaila C, Charrin C, Archimbaud E, Fiere D. Philadelphia chromosome positive adult acute lymphoblastic leukemia: characteristics, prognostic factors and treatment outcome. Hematol Cell Ther. 1998 Jun;40(3):119-28. PMID 9698220
- BACKGROUNDSnyder DS, Nademanee AP, O'Donnell MR, Parker PM, Stein AS, Margolin K, Somlo G, Molina A, Spielberger R, Kashyap A, Fung H, Slovak ML, Dagis A, Negrin RS, Amylon MD, Blume KG, Forman SJ. Long-term follow-up of 23 patients with Philadelphia chromosome-positive acute lymphoblastic leukemia treated with allogeneic bone marrow transplant in first complete remission. Leukemia. 1999 Dec;13(12):2053-8. doi: 10.1038/sj.leu.2401589. PMID 10602428
- BACKGROUNDArico M, Valsecchi MG, Camitta B, Schrappe M, Chessells J, Baruchel A, Gaynon P, Silverman L, Janka-Schaub G, Kamps W, Pui CH, Masera G. Outcome of treatment in children with Philadelphia chromosome-positive acute lymphoblastic leukemia. N Engl J Med. 2000 Apr 6;342(14):998-1006. doi: 10.1056/NEJM200004063421402. PMID 10749961
- BACKGROUNDDruker BJ, Tamura S, Buchdunger E, Ohno S, Segal GM, Fanning S, Zimmermann J, Lydon NB. Effects of a selective inhibitor of the Abl tyrosine kinase on the growth of Bcr-Abl positive cells. Nat Med. 1996 May;2(5):561-6. doi: 10.1038/nm0596-561. PMID 8616716
- BACKGROUNDDruker BJ, Sawyers CL, Kantarjian H, Resta DJ, Reese SF, Ford JM, Capdeville R, Talpaz M. Activity of a specific inhibitor of the BCR-ABL tyrosine kinase in the blast crisis of chronic myeloid leukemia and acute lymphoblastic leukemia with the Philadelphia chromosome. N Engl J Med. 2001 Apr 5;344(14):1038-42. doi: 10.1056/NEJM200104053441402.