Brief Title
LAMPP Trial for Peripheral and Cutaneous T-Cell Lymphoma
Official Title
LAMPP Trial for Peripheral and Cutaneous T-Cell Lymphoma
Brief Summary
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.
Detailed Description
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.
Study Type
Interventional
Primary Outcome
Evaluation of specific chemotherapy intervention
Condition
T-Cell Lymphoma
Intervention
Doxil, Methotrexate, L-Asparaginase, Prednisone
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
64
Start Date
February 2005
Completion Date
October 2007
Primary Completion Date
October 2007
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Roger Strair, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00161239
Organization ID
5192
Secondary IDs
CINJ#010410
Study Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
Ortho Biotech, Inc.
Study Sponsor
Roger Strair, MD, Principal Investigator, Rutgers, The State University of New Jersey
Verification Date
December 2009