Acute Lymphoblastic Leukemia
Conditions
Keywords
Acute Lymphoblastic Leukemia, Chromosome Philadelphia positive
Brief summary
Due to ALL Ph+ patients should receive a different treatment, is proposed a therapeutical protocol with: intensification treatment of induction to increment the CR rate, allogenic transplantation in first CR, autologous transplantation follow by alfa interferon in patients cannot done allogenic transplantation.
Detailed description
Remission Induction: * Vincristine (VCR): 1,5 mg/m2 i.v., days 1 and 8 * Daunorubicin (DNR): 60 mg/m2 i.v., days 1 and 8. * Prednisone (PDN): 60 mg/m2/day, i.v. or p.o., days 1 to 14 * L-asparaginase (L-ASA): 10.000 UI/m2, i.v.days 5-7 and 11-13 Results: 1\. Standard response: The induction treatment will be completed with the same drugs, changing L-ASA to ARA-C, during two more weeks 2 Slow response. Chemotherapy with mitoxantrone and high dose ARA-C Intrathecal chemotherapy: Treatment with mitoxantrone, ARA-C e hydrocortisone, days 1 and 22 CONSOLIDATION TREATMENT 1 Start in two weeks after last dose of induction chemotherapy: * Mercaptopurine (MP) 50 mg/m2, p.o., days 1-7, 28-35 and 56-63 * Mitoxantrone (MTX): 3g/m2, i.v., in 24 hours, day 1, 28 and 56. * VM-26: 150 mg/m2 every 12 horas, i.v. (infusión 1 hora), días 14 y 42 * ARA-C: 500 mg/m2 cada 12 hours, i.v., in 3 hours, days 14-15 and 42-43 * Intrathecal treatment, days 28 and 56. 6.4. CONSOLIDATION TREATMENT 2 Start in a week after last dose of mercaptopurine of previous cycle * Dexamethasone (DXM): * 10 mg/m2 day, p.o. or i.v. days 1-14 * 5 mg/m2 day, p.o. or i.v., days 15-21 * Vincristine (VCR): 1,5 mg/m2 i.v., days 1 and 8 and 15 * Daunorubicin (DNR): 30 mg/m2 i.v., days 1, 2, 8 and 9. * CFM 600 mg/m2 day, i.v., days 1 and 15 * L-asparaginase (L-ASA): 10.000 UI/m2, i.v.or im , days 1-3 and 15-17 * Intrathecal treatment days 1 and 15. TRANSPLANTATION Hematopoietic autologous transplantation with related donor, one or two months after last dose of consolidation treatment. Hematopoietic autologous transplantation with unrelated donor, in patients younger than 45, and with PS 0-1 Hematopoietic autologous transplantation in patients without related donor and without unrelated donor after six months searching
Interventions
DRUGVincristine
1,5 mg/m2 i.v., days 1 and 8
DRUGDaunorubicin
60 mg/m2, i.v., days 1 and 8
DRUGPrednisone
60 mg/m2 day, i.v. or oral, days 1 to 14
DRUGL-Asparaginase
10.000 UI/m2, i.v., days 5-7 and 11-13. Total: 6 doses.
DRUGMitoxantrone
12 mg/m2 i.v days 15, 16 and 17
1.500 mg/m2 /12 hours, days 16, 17 and 18 (total: 6 doses) If slow response to treatment: 3.000 mg/m2/12 hours, days 18, 19, 20 and 21 (8 doses)
DRUGHydrocortisone
10 mg ,15 mg or 20 mg depending of age
DRUGMercaptopurine
50 mg/m2, oral, days 1 to 7, 28-35 and 56-63 in consolidation
DRUGCyclophosphamide
600 mg/m2 day, i.v., days 1 to 15 in consolidation
DRUGDexamethasone
10 mg/m2 day, oral or i.v. days 1-14 5 mg/m2 day, oral. or i.v., days 15-21
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
ALL BCR/ABL+ patients Age \< 65 years No previous treatment
Exclusion criteria
1. Other LLA variability 2. Previous history of coronary valvular, hypertensive cardiopathy illness 3. Chronic hepatic illness 4. Chronic respiratory insufficiency 5. Renal insufficiency not caused by LLA 6. Severe neurological problems not caused by LLA 7. Severe affection of the performance status (grade 3-4 OMS gradation) not caused by LLA
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of treatment in order to response rate, relapse free survival and overall survival | 5 years |
Countries
Spain
Outcome results
None listed