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LAMPP Trial for Peripheral and Cutaneous T-Cell Lymphoma
This study has been terminated.
Study NCT00161239   Information provided by University of Medicine and Dentistry New Jersey
First Received: September 8, 2005   Last Updated: July 1, 2009   History of Changes

September 8, 2005
July 1, 2009
February 2005
 
Evaluation of specific chemotherapy intervention
Same as current
Complete list of historical versions of study NCT00161239 on ClinicalTrials.gov Archive Site
 
 
 
LAMPP Trial for Peripheral and Cutaneous T-Cell Lymphoma
LAMPP Trial for Peripheral and Cutaneous T-Cell Lymphoma

Peripheral T cell lymphoma and advanced cutaneous T cell lymphomas are aggressive and refractory diseases that are generally treated with chemotherapy. Despite current treatment modalities, only a subset of patients will be cured by the treatment. In this study, four chemotherapeutic agents (L-asparaginase, Methotrexate, Doxil, and Prednisone) will be administered in a combination regimen for patients with relapsed or refractory Peripheral and/or advanced cutaneous T cell lymphoma. Each one of these individual drugs have been shown to have activity to lymphomas. The objective of the study is to determine if the combination of these chemotherapy agents results in higher response and cure rates in this patient population. This will be a single institutional study which will included 32 patients in the Peripheral T cell lymphoma group and 32 patients in the Cutaneous T cell lymphoma group.

Peripheral T cell lymphoma and advanced cutaneous T cell lymphomas are aggressive and refractory diseases that are generally treated with chemotherapy. Despite current treatment modalities, only a subset of patients will be cured by the treatment. In this study, four chemotherapeutic agents (L-asparaginase, Methotrexate, Doxil, and Prednisone) will be administered in a combination regimen for patients with relapsed or refractory Peripheral and/or advanced cutaneous T cell lymphoma. Each one of these individual drugs have been shown to have activity to lymphomas. The objective of the study is to determine if the combination of these chemotherapy agents results in higher response and cure rates in this patient population. This will be a single institutional study which will included 32 patients in the Peripheral T cell lymphoma group and 32 patients in the Cutaneous T cell lymphoma group.

 
Interventional
Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment
T-Cell Lymphoma
Drug: Doxil, Methotrexate, L-Asparaginase, Prednisone
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
64
February 2008
 

Inclusion:

Patients must be at least 18 years of age. Histologically confirmed (including immunohistochemistry) diagnosis of T-Cell Lymphoma by skin biopsy or visceral/lymph node biopsy or bone marrow aspirate/biopsy Life expectancy of more than 3 months.

Exclusion:

Uncontrolled diabetes mellitus Active or serious infections uncontrolled with antibiotics Concurrent treatment, radiation or investigational treatment. 5.2.6 Significant underlying cardiac disease, including unstable angina, myocardial infarction less than 6 months before starting study, congestive failure of any cause

Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00161239
 
5192, CINJ#010410
University of Medicine and Dentistry New Jersey
Ortho Biotech, Inc.
Principal Investigator: Roger Strair, MD University of Medicine and Dentistry New Jersey
University of Medicine and Dentistry New Jersey
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP