Vincristine
Drug1,5 mg/m2 i.v., days 1 and 8
NCT Number: NCT00526305
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.
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Notify MeUp to 65 year
All sexes
Interventional
Phase 4
Hospital General de Alicante, Alicante, Spain
Remission Induction:
Results:
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:
6.4. CONSOLIDATION TREATMENT 2
Start in a week after last dose of mercaptopurine of previous cycle
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
ALL BCR/ABL+ patients Age < 65 years No previous treatment
Exclusion criteria
1,5 mg/m2 i.v., days 1 and 8
60 mg/m2, i.v., days 1 and 8
60 mg/m2 day, i.v. or oral, days 1 to 14
10.000 UI/m2, i.v., days 5-7 and 11-13. Total: 6 doses.
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)
10 mg ,15 mg or 20 mg depending of age
50 mg/m2, oral, days 1 to 7, 28-35 and 56-63 in consolidation
600 mg/m2 day, i.v., days 1 to 15 in consolidation
10 mg/m2 day, oral or i.v. days 1-14 5 mg/m2 day, oral. or i.v., days 15-21
Time frame: 5 years
PETHEMA Foundation
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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