LAMPP Trial for Peripheral and Cutaneous T-Cell Lymphoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2007-10-31

Brief Summary

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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

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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.

Conditions

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T-Cell Lymphoma

Keywords

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T-Cell Lymphomas

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Doxil, Methotrexate, L-Asparaginase, Prednisone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Roger Strair, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Locations

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Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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CINJ#010410

Identifier Type: -

Identifier Source: secondary_id

5192