Dettagli per singolo studio

DEC-NET Serial number FR321

Published online	28/09/2004 11.29.00
Last updated	27/11/2006 10.30.20

Other protocol ID number	CSTI571ACA01
Current trial status	Closed to recruitment of participants: follow-up continuing
Major Disease (ICD9 class)	MYELOID LEUKEMIA CHRONIC
Experimental drug
Imatinib Treatment regimen (dosage and duration) Patients will receive continuous once daily oral administration of Glivec® at a dose range of 260 to 340 mg/m2.
Gender	Both
Age (range)	< 18 years
Eligibility criteria
Inclusion criteria
-Diagnostic criteria : CML Ph chromosome + who are in accelerated phase, in blast crisis, in chronic phase refractory or intolerant to IFN-alpha or in relapse after stem cell transplantation. - Clinical criteria : Lansky Performance Status Score > 60. - Biological criteria : SGOT and SGPT lower than 3times the upper limit of the normal range (3 ULN). If clinically suspected leukemic involvement of the liver, SGOT and SGPT should not be more 5 5UNL). Serum creatinine concentration : 2 ULN. Total serum bilirubin level 3 ULN -Female patients of childbearing potential must have a negative pregnancy test prior to the initiation of study drug. Barrier contraceptive precautions are to be used in teenagers throughout the trial in both sexes. -Written voluntary informed consent of the parents
Exclusion criteria
1. Patients with an Lansky Performance Status Score <60. 2. Patients must not have received any of the following: - Busulfan within six weeks of Day 1 - Interferon-alpha within 48-hours of Day 1 - Hydroxyurea within 24-hours of Day 1 - Homoharringtonine within 14 days of Day 1 - Low-dose cytosine arabinoside (< 30 mg/m2 every 12 to 24 hours administered daily) within 7 days of Day 1 - Moderate-dose cytosine arabinoside (100-200 mg/m2 for 5 to 7 days) within 14 days of Day 1. - High-dose cytosine arabinoside (1-3 g/m2 every 12 to 24 hours administered for 6 to 12 doses) within 28 days of Day 1. - Anthracyclines, mitoxantrone, or etoposide within 21 days of Day 1 - Any hematopoietic stem cell transplantation within six weeks of Day 1. 3. Patient receiving any other investigational agents within 28 days of Day 1. 4. Patients with Grade 3/4 cardiac disease. 5. Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable. 6. Patients with any serious concomitant medical condition
Trial design/methodology
Phase	2
Kind of study	Efficacy Safety
Design
Purpose of study
* Primary objectives: To determine the rate of hematological response (confirmed after > 4 weeks). * Secondary objectives: a) To evaluate improvement of symptomatic parameters. b) To evaluate cytogenetic response rates. c) To evaluate time to and duration of cytogenetic responses. d) To evaluate the molecular response e) To evaluate the safety profile of Glivec®. f) To determine time to and duration of hematological responses. g) To evaluate overall survival.
Primary outcomes
- Rate of hematological response. - Safety Evaluation (hematologic and extra-hematologic tolerance)
Secondary outcomes
- Improvement of clinical parameters. - Cytogenetic response rate. - Time to and duration of the cytogenetic response - Molecular Response - Safety profile - Time to and duration of hematological response - Overall Survival
Summary of study design, objectives, and ongoing research findings
This is a Phase II, multi-center, open-label, non-randomized trial in children with chronic myeloid leukemia. . Part 1, patients will receive once daily oral administration of Glivec® at a dose of range of 260 to 340 mg/m2 for 24 weeks. After completing 24 weeks of therapy, patients may be eligible to receive additional therapy during Part 2 : patients are elligible if they have benefited from Glivec® and in the absence of safety concerns. They continue to receive Glivec® on a daily basis until either death, the development of intolerable toxicity or the investigator feels it is no longer in the patient.s best interest to continue therapy. This Phase II trial will investigate the antiproliferative effects of Glivec® as defined primarily by response, and secondarily by overall survival, duration of hematological response, cytogenetic response, (decrease in the number of Ph chromosome-positive metaphases in the bone marrow), molecular response and symptom improvement. Patients who discontinue study drug prior to death will be follow indefinitively for survival.