Know Cancer

or
forgot password

Phase II Trial to Study the Tolerability and the Effectiveness of Imatinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase With Age More Than 70, Diagnosis of CML is Being Performed Within 1 Year


Phase 2
70 Years
N/A
Not Enrolling
Both
Chronic Myeloid Leukemia

Thank you

Trial Information

Phase II Trial to Study the Tolerability and the Effectiveness of Imatinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase With Age More Than 70, Diagnosis of CML is Being Performed Within 1 Year


Patients will received Imatinib at a dose of 400mg daily. Tolerability and quality of life
will be assessed Secondary objectives are : to evaluate the survival without progression,
the survival without event, the overall survival, the hematologic, cytogenetic and molecular
responses at various check points.

Duration of responses and failure to respond will be evaluated.


Inclusion Criteria:



- CML Ph+ (assessed by cytogenetic or FISH)

- Chronic phase with less than 5% bone marrow blasts

- Diagnosis within 12 months

- Age ≥ 70 year at inclusion

- PS grade 0 to 2 (ECOG)

- Mini mental status more than 25

- Hydroxyurea optional before Imatinib

- Adequate end organ function, defined as the following: total bilirubin <1.5x uln,
sgpt <3x uln, creatinine <1.5x uln.

Exclusion Criteria:

- patients who cannot sign an informed consent indicating that they are aware of the
investigational nature of this study in keeping with the policies of the hospital

- Mini mental status ≤ 25

- patients who are not able to adequately take the study drug

- Age less than 70 y

- accelerated or blastic phase

- previous therapy with imatinib or interferon

- HIV positivity

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tolerability

Principal Investigator

François GUILHOT, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Department of Oncology hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

020948

NCT ID:

NCT00219752

Start Date:

May 2002

Completion Date:

May 2007

Related Keywords:

  • Chronic Myeloid Leukemia
  • CML - ederly patients - Imatinib mesylate
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Name

Location