Acute Myeloid Leukemia Clinical Trial
Official title:
A Phase 3 Trial of Systematic Versus Response-adapted Timed-Sequential Induction in Patients With Core Binding Factor (CBF) Acute Myeloid Leukemia (AML)
Verified date | July 2007 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Interventional |
Core binding factor (CBF) acute myeloid leukemias (AML) include AMLs carrying the t(8;21)
translocation as well as AMLs carrying either the inversion of chromosome 16 or
translocation t(16;16). CBF-AMLs are characterized by their high sensitivity to standard
chemotherapeutical agents, especially to cytarabine when administered as high-dose bolus
infusions, and thus by a relative good prognosis. However, relapse rates are still comprised
between 30 and 50% in these patients, even if overall survival may reach approximately 65%
due to the potential salvage of late relapses.
The primary purpose of the protocol is to compare two modalities of timed-sequential
induction in order to improve the results of the treatment of CBF-AML patients. This
protocol also includes the biological characterization of the heterogeneity of these
diseases (gene mutation and transcription profiles), as well as a centralized minimal
residual disease monitoring and centralized evaluation of pharmacogenetic polymorphisms.
Status | Completed |
Enrollment | 200 |
Est. completion date | June 2011 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Patients aged 18-60 years. - With a newly-diagnosed de novo or therapy-related CBF-AML defined Exclusion Criteria: - No previously treated with any anti-leukemic agent. - No presenting any diagnosis of uncontrolled or metastatic tumor. - OMS performance status < 2, - Absence of uncontrolled severe infection, - AST and ALT 2.5 x ULN, - Total bilirubin 1.5 x ULN, - Serum creatinine 1.5 x ULN |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Service Hematologie Oncologie | Nimes |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Acute Leukemia French Association, Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS |
France,
Appelbaum FR, Kopecky KJ, Tallman MS, Slovak ML, Gundacker HM, Kim HT, Dewald GW, Kantarjian HM, Pierce SR, Estey EH. The clinical spectrum of adult acute myeloid leukaemia associated with core binding factor translocations. Br J Haematol. 2006 Oct;135(2) — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary objective of the study is to increase the Event-free Survival (EFS) | during the 60 months | No | |
Secondary | The complete remission (CR) rate, molecular response (MRD), cumulative incidence of relapse (CIR), disease-free survival (DFS), and overall survival (OS) in both randomization groups. | during the 60 months | Yes | |
Secondary | The toxicity of both induction strategies (induction deaths and further deaths in first CR). | during the 60 months | Yes | |
Secondary | The relative prognostic value of : 1) WBC; 2) Mutational status (FLT3, c-Kit, and Ras mutations); and 3) MRD in patient outcome (CR rate, CIR, EFS, DFS, OS). | during the 60 months | Yes | |
Secondary | The prognostic value of CBF-AML subsets defined on Gene Expression Profiling (GEP) basis. | during the 60 months | No | |
Secondary | The prognostic impact of known polymorphisms of genes involved in the metabolism of cytarabine and anthracyclines (Pharmacogenetic study). | during the 60 months | Yes | |
Secondary | of patients with CBF-AML through the administration of a systematic | during the 60 months | No | |
Secondary | timed-sequential induction (arm A) as compared to a response-adapted | during the 60 months | No | |
Secondary | timed-sequential induction (arm G). | during the 60 months | No |
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