Acute Lymphoblastic Leukemia, Cromosome Philadelphia Positive
Conditions
Keywords
Acute lymphoblastic Leukemia
Brief summary
% positive Ph LLA with RC alter the Glivec and induction chemotherapy treatment
Detailed description
Pilot phase II clinical trial, prospective, multicentric and opened
Interventions
DRUGchemotherapy
DRUGGlivec
Sponsors
PETHEMA Foundation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| % positive Ph LLA with RC alter the Glivec and induction chemotherapy treatment. | — |
| Discover if is possible to treat patients with Glivec plus Standard consolidation treatment. | — |
| Discover the Glivec effect over ERM during consolidation treatment and alter transplant | — |
Countries
Spain
Outcome results
None listed