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| ID | Type | Description | Link |
|---|---|---|---|
| CSTI571AFR01 |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
| Novartis | INDUSTRY |
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imatinib mesylate 600 mg | Drug | |||
| Cytarabine | Drug | |||
| Daunorubicine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| - To evaluate the survival without progression, the survival without event, the overall survival, the hematologic, cytogenetic and molecular responses at various check points. | ||
| - To evaluate duration of responses and failure to respond |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| François GUILHOT, MD | Department of Oncology hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Poitiers | 86021 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22987312 | Derived | Rousselot P, Cony-Makhoul P, Nicolini F, Mahon FX, Berthou C, Rea D, Reiffers J, Bornand A, Saint-Jean O, Guilhot J, Guilhot F; French Intergroup For Chronic Myelogenous Leukemia (Fi-LMC). Long-term safety and efficacy of imatinib mesylate (Gleevec(R)) in elderly patients with chronic phase chronic myelogenous leukemia: results of the AFR04 study. Am J Hematol. 2013 Jan;88(1):1-4. doi: 10.1002/ajh.23330. Epub 2012 Sep 17. | |
| 21145590 |
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| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| D003561 | Cytarabine |
| D003630 | Daunorubicin |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 |
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| Derived |
| Deau B, Nicolini FE, Guilhot J, Huguet F, Guerci A, Legros L, Pautas C, Berthou C, Guyotat D, Cony-Makhoul P, Gardembas M, Michallet M, Hayette S, Cayuela JM, Weiss IR, Rea D, Castaigne S, Mahon FX, Guilhot F, Rousselot P. The addition of daunorubicin to imatinib mesylate in combination with cytarabine improves the response rate and the survival of patients with myeloid blast crisis chronic myelogenous leukemia (AFR01 study). Leuk Res. 2011 Jun;35(6):777-82. doi: 10.1016/j.leukres.2010.11.004. Epub 2010 Dec 10. |
| D009196 |
| Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |