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Phase I/II Trial to Study the Dose, Tolerability and the Effectiveness of Imatinib in Combination With Daunorubicine and Cytarabine for Patients With Chronic Myelogenous Leukemia in Myeloid Acute Phase


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Chronic Myeloid Leukemia

Thank you

Trial Information

Phase I/II Trial to Study the Dose, Tolerability and the Effectiveness of Imatinib in Combination With Daunorubicine and Cytarabine for Patients With Chronic Myelogenous Leukemia in Myeloid Acute Phase


Study design Imatinib: starting at day –3: 600mg/day; continuous administration In
combination with cytarabine: continuous iv/24h: 100mg/m² ; 7 days and daunorubicine: 4
levels

level 1: 0

level 2: 15mg/m² ; 3 days

level 3: 30mg/m² ; 3 days

level 4: 45mg/m² ; 3 days


Inclusion Criteria:



- CML Ph+ (assessed by cytogenetic or FISH)

- Acute phase with ≥ 20% bone marrow blasts (M0 to M6 , excluding M3)

- Age ≥ 18 year at inclusion

- PS grade 0 to 2 (ECOG)

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

- Informed consent signed up

Exclusion Criteria:

- active malignancy other than CML or non-melanoma cancer of the skin

- current treatment with another investigational agent

- patients with grade 3/4 cardiac disease or any other serious concurrent medical
condition.

- patients who are pregnant or nursing. All patients of childbearing potential must
practice effective methods of contraception while on study.

- patients with mental illness or other condition precluding their ability to give
informed consent or to comply with study requirements patients with performans status
3-4

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:

To assess the tolerability and the effectiveness of imatinib in combination with daunorubicine and cytarabine and to determine the recommended dose of daunorubicine to be associated with cytarabine

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:

010495

NCT ID:

NCT00219765

Start Date:

May 2001

Completion Date:

January 2006

Related Keywords:

  • Chronic Myeloid Leukemia
  • CML
  • Acute Phase
  • Imatinib mesylate
  • Cytarabine
  • Daunorubicine
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

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