Efficacy of the HCVIDDOXIL Regimen in Patients With Newly Diagnosed Peripheral T-Cell Lymphoma
|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: NCT00290433|
Recruitment Status : Completed
First Posted : February 13, 2006
Last Update Posted : July 14, 2015
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: Cyclophosphamide Drug: Mesna Drug: Vincristine Drug: Methotrexate Drug: Ara-C Drug: Dexamethasone Drug: G-CSF Drug: Doxil||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of the Efficacy of the HCVIDDOXIL Regimen in Patients With Newly Diagnosed Peripheral T Cell Lymphoma|
|Study Start Date :||September 2003|
|Primary Completion Date :||July 2015|
|Study Completion Date :||July 2015|
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.
- Progression-Free Survival [ Time Frame: 41 days ]Progression-free survival measured from start of first cycle of chemotherapy to first detection of disease progression.
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): 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|