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A Phase II Study Evaluating the Efficacy and Tolerance of Combination Therapy of Imatinib Mesylate (IM) +-2A Interféron for Chronic Phase CML Patients Resistant or Refractory to IM Used as Single Therapy for at Least One Year


Phase 2
18 Years
90 Years
Open (Enrolling)
Both
Chronic Myeloid Leukemia

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Trial Information

A Phase II Study Evaluating the Efficacy and Tolerance of Combination Therapy of Imatinib Mesylate (IM) +-2A Interféron for Chronic Phase CML Patients Resistant or Refractory to IM Used as Single Therapy for at Least One Year


Inclusion Criteria:



- Chronic phase Philadelphia positive CML, confirmed by karyotyping (or FISH) analysis,
in complete hematologic response with IM.

- Lack of major cytogenetic response after at least one year of STI 571 as single
therapy.

- Male and female * 18 years old.

- Informed consent signed up.

- Performance status grade 0 - 2 (ECOG).

- SGOT and SGPT <3N

- Serum bilirubin < 1.5 N

- Serum creatinine < 1.5 N

- No HSC graft planned

- B-HCG negative for female with potential childbearing

Exclusion Criteria:

- Absence of complete hematologic response

- Extramedullar involvement

- Previous extra-hematologic intolerance of Interféron at a dose superior or equal to
25 MUI/week

- Depressive syndrome not controlled

- Not controlled dysthyroidy

- Auto-immune pathology not controlled

- Women with childbearing potential who are unwilling or unable to use an adequate
method to avoid pregnancy for the entire period of the study

- Significant cardiac disease (grade 3 or more)

- Known seropositivity for HIV

- Active viral hepatitis

- Other malignant disease

- Other experimental medication

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Study the maintenance of a complete hematologic response, the cytogenetic and molecular responses, and the overall survival of the patients population

Principal Investigator

Mauricette MICHALLET, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospices Civils de Lyon

Authority:

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

Study ID:

2003.317

NCT ID:

NCT00146913

Start Date:

March 2004

Completion Date:

Related Keywords:

  • Chronic Myeloid Leukemia
  • Chronic myeloid leukaemia
  • resistant
  • refractory
  • Imatinib mesylate
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid, Chronic-Phase

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