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Front-line Treatment of Ph Positive (Ph+)/Bcr-Abl Positive Acute Lymphoblastic Leukemia (ALL) With Two Tyrosine Kinase Inhibitors (TKI) (Imatinib and Nilotinib). A Phase II Exploratory Multicentric Study in Elderly Patients and in Patients Unfit for Program of Intensive Therapy and Allogeneic Stem Cell Transplantation. GIMEMA Protocol LAL1408. EudraCT 2009-01327122


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Treatment, Stem Cell Transplantation

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Trial Information

Front-line Treatment of Ph Positive (Ph+)/Bcr-Abl Positive Acute Lymphoblastic Leukemia (ALL) With Two Tyrosine Kinase Inhibitors (TKI) (Imatinib and Nilotinib). A Phase II Exploratory Multicentric Study in Elderly Patients and in Patients Unfit for Program of Intensive Therapy and Allogeneic Stem Cell Transplantation. GIMEMA Protocol LAL1408. EudraCT 2009-01327122


Inclusion Criteria:



- Previously untreated Ph+ ALL more than 60 years old or more than 18 years old, but
unfit for program of intensive therapy and allogeneic SCT

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-Free Survival (DFS)

Outcome Time Frame:

at 24 months

Safety Issue:

No

Principal Investigator

Michele Baccarani

Investigator Role:

Principal Investigator

Investigator Affiliation:

Policlinico Sant'Orsola

Authority:

Italy: The Italian Medicines Agency

Study ID:

LAL1408

NCT ID:

NCT01025505

Start Date:

February 2010

Completion Date:

January 2018

Related Keywords:

  • Treatment
  • Stem Cell Transplantation
  • Untreated Ph+ ALL unfit for intense therapy and allo SCT
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

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