Efficacy of the HCVIDDOXIL Regimen in Patients With Newly Diagnosed Peripheral T-Cell Lymphoma
The goal of this clinical research study is to learn if treatment with two types of chemotherapy combinations can help to control peripheral T-cell lymphoma.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of the Efficacy of the HCVIDDOXIL Regimen in Patients With Newly Diagnosed Peripheral T Cell Lymphoma|
- Progression-Free Survival [ Time Frame: 41 days ] [ Designated as safety issue: No ]Progression-free survival measured from start of first cycle of chemotherapy to first detection of disease progression.
|Study Start Date:||September 2003|
|Study Completion Date:||July 2015|
|Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Experimental: HCVIDDOXIL Regimen
Cycle 1: Cyclophosphamide by vein two times a day on Days 1,2, and 3. Mesna by vein nonstop over Days 1 through 3. Pegylated liposomal doxorubicin by vein over 1 hour on Day 2. Vincristine by vein on Days 4 and 11. Dexamethasone by mouth on Days 1 through 4 and 11 through 14.
Cycle 2: Methotrexate by vein over 2 hours on Day 1 and over 22 hours on day 1. Cytarabine by vein twice a day on Days 2 and 3.
Cycle 1: 300 mg/m^2 by vein Over 3 Hours Twice Daily on Days 1, 2, and 3.
Other Names:Drug: Mesna
Cycle 1: 600 mg/m^2 by vein Continuous Infusion Over Days 1, 2, and 3.Drug: Vincristine
Cycle 1: 1.4 mg/m^2 by vein On Day 4 and 11.Drug: Methotrexate
Cycle 1 and 2: 200 mg/m^2 by vein Over 2 Hours on Day 1, followed by 800 mg/m^2 IV Over 22 Hours on Day 1.Drug: Ara-C
Cycle 1 and 2: 3 Gm/m^2 Over 2 Hours Twice Daily On Days 2 and 3.
Other Names:Drug: Dexamethasone
Cycle 1: 40 mg by vein or by mouth daily on Days 1-4 and 11-14.
Other Name: DecadronDrug: G-CSF
Cycle 1 and 2: 300 or 480 mcg subcutaneously 24 hours after end of Day 4 vincristine.
Other Names:Drug: Doxil
Cycle 1: 25 mg/m^2 by vein Over 1 Hour on Day 2.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00290433
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Yasuhiro Oki, MD||M.D. Anderson Cancer Center|