Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Nelarabine in Patients With Relapsed/Refractory Lymphoid Malignancies
The goal of the clinical research study is to find the highest tolerable dose of nelarabine when given as a continuous infusion to patients with a lymphoid malignancy that has not responded to, or has come back after treatment with chemotherapy. The safety of this drug will also be studied.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pharmacokinetic and Pharmacodynamic Study to Evaluate the Safety and Feasibility of Continuous Infusion Nelarabine in Patients With Relapsed / Refractory Lymphoid Malignancies|
- Maximum Tolerated Dose (MTD) of a 5-day Continuous Infusion Schedule of Nelarabine [ Time Frame: 28 day cycle ] [ Designated as safety issue: Yes ]MTD defined as the highest dose that no more than 1 dose limiting toxicity (DLT) occurs among 6 patients. Dose-limiting toxicity (DLT) defined based on drug related events only. DLT in the first treatment cycle used for the dose escalation.
|Study Start Date:||June 2010|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Experimental: Continuous Infusion Nelarabine
Starting dose 200 mg/m2 x 5 days
Starting dose 200 mg/m2 for 5 day continuous infusion administered via a central catheter, repeated every 28 days.
Other Name: Arranon
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01094860
|Contact: Tapan Kadia, MD||713-792-7305|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: Tapan Kadia, MD|
|Study Chair:||Tapan Kadia, MD||M.D. Anderson Cancer Center|