STI571 ProspectIve RandomIzed Trial: SPIRIT (SPIRIT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00219739|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : October 11, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myeloid Leukemia||Drug: Imatinib mesylate 400 mg Drug: Imatinib mesylate 600 mg Drug: Imatinib 400 mg + Peg-Interferon Drug: Imatinib mesylate 400 mg + Cytarabine||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||789 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||September 2003|
|Primary Completion Date :||December 2014|
|Experimental: Imatinib mesylate 400 mg||Drug: Imatinib mesylate 400 mg Drug: Imatinib mesylate 600 mg Drug: Imatinib 400 mg + Peg-Interferon Drug: Imatinib mesylate 400 mg + Cytarabine|
|Experimental: Imatinib mesylate 600 mg||Drug: Imatinib mesylate 400 mg Drug: Imatinib mesylate 600 mg Drug: Imatinib 400 mg + Peg-Interferon Drug: Imatinib mesylate 400 mg + Cytarabine|
|Experimental: Imatinib mesylate 400 mg +Peg interferon|
|Experimental: Imatinib mesylate 400 mg +Cytarabine|
- Overall survival improvement
- Molecular response improvement at 1 year [ Time Frame: 1 year ]
- Hematological, cytogenetic responses improvement [ Time Frame: 1 year ]
- Duration of responses improvement
- Survival without progression improvement
- Acceptable toxicity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00219739
|Poitiers, France, 86021|
|Study Chair:||François GUILHOT, MD||Department of Oncology hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE|