LAMPP Trial for Peripheral and Cutaneous T-Cell Lymphoma - Tabular View

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LAMPP Trial for Peripheral and Cutaneous T-Cell Lymphoma

This study is currently recruiting participants.

Study NCT00161239. Last updated on April 27, 2007. Information provided by University of Medicine and Dentistry New Jersey

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

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

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment

Primary Outcome Measure ^†

Evaluation of specific chemotherapy intervention

Secondary Outcome Measure ^†

Condition ^†

T-Cell Lymphoma

Intervention ^†

Drug: Doxil, Methotrexate, L-Asparaginase, Prednisone

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

Start Date ^†

February 2005

Completion Date

February 2008

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

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00161239

Organization ID

5192

Secondary IDs ^††

CINJ#010410

Study Sponsor ^†

University of Medicine and Dentistry New Jersey

Collaborators ^††

Ortho Biotech Products, L.P.

Investigators ^†

Principal Investigator:

Roger Strair, MD

University of Medicine and Dentistry New Jersey

Information Provided By

University of Medicine and Dentistry New Jersey

Verification Date

September 2005

First Received Date ^†

September 8, 2005

Last Updated Date

April 27, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.