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A Randomized, Multicenter Open Label Phase II Study to Determine the Safety and Efficacy of Induction Therapy With Imatinib in Comparison With Standard Induction Chemotherapy in Elderly (> 55 Years) Patients With Ph Positive Acute Lymphoblastic Leukemia (ALL)


Phase 2
56 Years
N/A
Open (Enrolling)
Both
Philadelphia Positive Acute Lymphoblastic Leukemia, Lymphoid Blastic Phase of Chronic Myeloid Leukemia

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Trial Information

A Randomized, Multicenter Open Label Phase II Study to Determine the Safety and Efficacy of Induction Therapy With Imatinib in Comparison With Standard Induction Chemotherapy in Elderly (> 55 Years) Patients With Ph Positive Acute Lymphoblastic Leukemia (ALL)


Inclusion Criteria:



- Male or female patients

- Age > 55 years (biological age)

- Diagnosis of Ph1 chromosome-positive ALL (pre-B, common- or pre-pre-B ALL)

- Newly diagnosed, lymphoid blast crisis of chronic myeloid leukemia

- Only pre-phase chemotherapy prior to study start

- World Health Organization (WHO) status 0, 1 or 2

- Voluntary written informed consent

Exclusion Criteria:

- Creatinine levels more than 2 x the upper limit of normal (ULN)

- Total serum bilirubin more than 1.5 x the ULN

- AST (SGOT) or ALT (SGPT) more than 5 x the ULN

- Any other prior antineoplastic treatment except for pre-phase chemotherapy

- Active central nervous system (CNS) leukemia

- New York Heart Association (NYHA) grade 3/4 cardiac disease

- Active severe infection

- Serious concomitant medical condition

- Patients with a history of non-compliance to medical regimens

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Remission rate after induction therapy

Principal Investigator

Oliver G Ottmann, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Medizinische Klinik II, Johann Wolfgang Goethe Universit├Ąt

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

CSTI571ADE10

NCT ID:

NCT00199186

Start Date:

March 2002

Completion Date:

Related Keywords:

  • Philadelphia Positive Acute Lymphoblastic Leukemia
  • Lymphoid Blastic Phase of Chronic Myeloid Leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

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