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Imatinib Mesylate

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Imatinib mesylate 400 mg

Imatinib mesylate 600 mg

Imatinib 400 mg + Peg-Interferon

Imatinib mesylate 400 mg + Cytarabine

François GUILHOT, MD

To test whether increasing the dose of imatinib or combining it with IFNalpha or ara-C increases the rate of molecular response (as measured by the decrease in BCR-ABL transcripts after 12 months of treatment) in patients with previously untreated CML in chronic phase.

To compare overall survival in a selected arm according to molecular response at 1 year from randomization with the reference arm.

Imatinib at 400 mg daily has emerged as the preferred therapy for newly diagnosed CML patients who do not undergo allogeneic stem cell transplant.

A phase III randomized study, comparing imatinib at 400 mg per day to interferon plus cytarabine in newly diagnosed chronic phase CML patients enrolled 1106 patients from June 2000 to January 2001. 553 patients were randomized to each treatment. For comparative purposes, at 6 months, 75% of patients randomized to imatinib obtained a major cytogenetic response with 51% complete responses. Despite these impressive results, only a minority of patients treated with imatinib in this study achieved a molecular remission. When analyzed by log reduction in Bcr-Abl transcript levels using quantitative RT-PCR, 39% of patients achieved a 3-log reduction in Bcr-Abl levels, but only 13% and 3% achieved a 4- and 5-log reduction, respectively.2 To improve upon these results, various groups have tried higher doses of imatinib, and combinations of imatinib with interferon alpha or cytarabine. Each of these studies has used cytogenetic responses as the major endpoint.

Each of these therapies has increased toxicity as compared to 400 mg of imatinib alone and the rates of molecular remissions have not been reported.

Thus the purpose of this study is to first determine whether higher doses of imatinib or combining Imatinib with interferon or Ara-C would result in higher rates of molecular responses and if so, in better survival.

STI571 ProspectIve RandomIzed Trial: SPIRIT

A Phase III Prospective Randomized Comparison of Imatinib at a Dose of 400mg in Combination With Peg-Interferon-alpha2a (Peg-IFNa2a) or Cytarabine (Ara-C)Versus Imatinib at a Dose of 600mg Versus Imatinib a Dose of 400mg for Previously Untreated Chronic Myelogenous Leukemia (CML) in Chronic Phase

Ministry of Health, France

Novartis

Roche Pharma AG

Poitiers University Hospital

Acute Graft Versus Host Disease

Daunorubicin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Daunorubicine

The aim of this phase I/II trial is to determine the dose of daunorubicine to be associated with cytarabine and Imatinib for induction therapy in 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

Safety and Efficacy of Imatinib in Combination With High Dose Chemotherapy for Acute Phase Chronic Myelogenous Patients

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 title	NCT ID	Conditions	Interventions	Eligibility	Organization
STI571 ProspectIve RandomIzed Trial: SPIRIT	NCT00219739	Chronic Myeloid...	Imatinib mesyla... Imatinib mesyla... Imatinib 400 mg... Imatinib mesyla...	18 Years -	Poitiers University Hospital
Safety and Efficacy of Imatinib in Combination With High Dose Chemotherapy for Acute Phase Chronic Myelogenous Patients	NCT00219765	Chronic Myeloid...	Imatinib mesyla... Cytarabine Daunorubicine	18 Years -	Poitiers University Hospital
STI571 ProspectIve RandomIzed Trial: SPIRIT	NCT00219739	Chronic Myeloid...	Imatinib mesyla... Imatinib mesyla... Imatinib 400 mg... Imatinib mesyla...	18 Years -	Poitiers University Hospital

Spots Global Cancer Trial Database for imatinib mesylate 600 mg