"Geriatric Assessment Adapted" Therapy for Ph- ALL Elderly Patients. GIMEMA Protocol LAL1104. EudraCT Code 2005-002156-17
Treatment:
1. Frail patients:
- Pretreatment with PDN
- Induction with Vinblastine and PDN
- Maintenance with MTX, 6-MP, VBL and PDN
2. Fit patients:
- Pretreatment with PDN
- Induction with VCR, DNR and PDN
- Consolidation with MTX, ARA-C and G-CSF
- Autologous transplantation
- Maintenance with MTX, 6-MP, VCR, and PDN
3. Intermediate patients:
- Pretreatment with PDN
- Induction with VCR, DNR and PDN
- Consolidation with MTX, ARA-C and G-CSF
- A second cycle of consolidation therapy
- Maintenance with MTX, 6-MP, VCR, and PDN
Interventional
Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival in Ph negative ALL patients stratified according to a geriatric assessment
at 6 months from diagnosis for the Frail group of pts and at 2 years from diagnosis for the Fit and Intermediate group of patients
No
Felicetto FERRARA, Dr.
Principal Investigator
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" di Napoli
Italy: The Italian Medicines Agency
LAL1104
NCT00475280
November 2007
June 2013
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