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LAMPP Trial for Peripheral and Cutaneous T-Cell Lymphoma

Primary Purpose

T-Cell Lymphoma

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Doxil, Methotrexate, L-Asparaginase, Prednisone
Sponsored by
University of Medicine and Dentistry of New Jersey
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for T-Cell Lymphoma focused on measuring T-Cell Lymphomas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cancer Institute of New Jersey

Outcomes

Primary Outcome Measures

Evaluation of specific chemotherapy intervention

Secondary Outcome Measures

Full Information

First Posted
September 8, 2005
Last Updated
December 10, 2009
Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
Ortho Biotech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00161239
Brief Title
LAMPP Trial for Peripheral and Cutaneous T-Cell Lymphoma
Official Title
LAMPP Trial for Peripheral and Cutaneous T-Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Terminated
Why Stopped
toxicity
Study Start Date
February 2005 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
Ortho Biotech, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
T-Cell Lymphoma
Keywords
T-Cell Lymphomas

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Doxil, Methotrexate, L-Asparaginase, Prednisone
Primary Outcome Measure Information:
Title
Evaluation of specific chemotherapy intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger Strair, MD
Organizational Affiliation
Rutgers, The State University of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States

12. IPD Sharing Statement

Learn more about this trial

LAMPP Trial for Peripheral and Cutaneous T-Cell Lymphoma

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