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"Geriatric Assessment Adapted" Therapy for Ph- ALL Elderly Patients. GIMEMA Protocol LAL1104. EudraCT Code 2005-002156-17


Phase 2
60 Years
N/A
Open (Enrolling)
Both
Leukemia, Lymphoblastic, Acute

Thank you

Trial Information

"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


Inclusion Criteria:



- Age > 60 years old

- Cytomorphologic and immunophenotypic diagnosis of ALL (all FAB groups except L3 and
all immunophenotypes except SmIg+ B-ALL)

- Signed informed consent

Exclusion Criteria:

- Age <= 60 years old

- Ph+ ALL

- Refuse to sign informed consent

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival in Ph negative ALL patients stratified according to a geriatric assessment

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Felicetto FERRARA, Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" di Napoli

Authority:

Italy: The Italian Medicines Agency

Study ID:

LAL1104

NCT ID:

NCT00475280

Start Date:

November 2007

Completion Date:

June 2013

Related Keywords:

  • Leukemia, Lymphoblastic, Acute
  • geriatric assessment adapted therapy
  • Leukemia, Lymphoblastic, Acute
  • Older patients
  • > 60 years old
  • Ph negative
  • Leukemia
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

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