Cilengitide in Treating Patients With Acute Myeloid Leukemia
Adult Acute Basophilic Leukemia
Adult Acute Eosinophilic Leukemia
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Monoblastic Leukemia (M5a)
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)
Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Adult Erythroleukemia (M6a)
Adult Pure Erythroid Leukemia (M6b)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of EMD 121974 as Maintenance Therapy for Patinets With Acute Myeloid Leukemia in Complete Remission|
- Disease-free survival (DFS) [ Time Frame: From initiation of induction chemotherapy until the first incidence of disease or death due to any cause, assessed up to 2 years ] [ Designated as safety issue: No ]Kaplan-Meier curves will be constructed for each treatment group. Median DFS in each group and corresponding 95% confidence intervals will be estimated. The two treatment groups will be compared using log-rank test.
- Overall survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]Analyzed using Kaplan-Meier life table methods and Cox proportional hazard regression modeling.
- Toxicity of cilengitide graded using the CTC version 3 [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]Compared between the two treatment arms using Fisher's exact test
|Study Start Date:||July 2004|
|Primary Completion Date:||June 2006 (Final data collection date for primary outcome measure)|
Experimental: Arm I (low dose cilengitide)
Patients receive cilengitide IV at a lower dose over 1 hour twice weekly for 4 weeks.
Other Name: EMD 121974
Experimental: Arm II (higher dose cilengitide)
Patients receive cilengitide IV at a higher dose over 1 hour twice weekly for 4 weeks.
Other Name: EMD 121974
I. Determine 10-month relapse-free survival of patients with acute myeloid leukemia in first complete remission treated with cilengitide as maintenance therapy.
I. Determine overall survival of patients treated with this drug. II. Determine the safety and toxicity of this drug in these patients. III. Determine the biological activity of this drug in cells from these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive cilengitide IV at a lower dose over 1 hour twice weekly for 4 weeks.
Arm II: Patients receive cilengitide IV at a higher dose over 1 hour twice weekly for 4 weeks.
In both arms, courses repeat every 4 weeks in the absence of disease relapse or unacceptable toxicity.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00089388
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Srdan Verstovsek||M.D. Anderson Cancer Center|