Study of Motexafin Gadolinium for the Treatment of Non-Hodgkin's Lymphoma

NCT ID: NCT00086034

Last Updated: 2007-05-15

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Brief Summary

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The primary purpose of this study is to find out if motexafin gadolinium may be an effective treatment for patients with non-Hodgkin's lymphoma (NHL). Secondly, the safety and side effects of motexafin gadolinium will be evaluated.

Detailed Description

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Conditions

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Lymphoma Non-Hodgkin's Lymphoma

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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Motexafin gadolinium

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ≥ 18 years old
* Refractory or relapsed indolent NHL. Eligible WHO histologies include follicular NHL (Grades 1, 2, and 3); marginal zone nodal; marginal zone splenic; and mucosa-associated lymphoid tissue (MALT) types
* Failed ≥ 1 previous regimens, one of which must have contained rituximab as either a single agent or in combination with chemotherapy
* ECOG performance status score either 0 or 1
* Willing and able to provide written informed consent

Exclusion Criteria

Laboratory values of:

* Platelet count \< 50,000/µL
* AST or ALT \> 2 x the upper limit of normal (ULN)
* Total bilirubin \> 2 x ULN
* Creatinine \> 2.0 mg/dL

and

* Greater than three prior regimens (where a regimen is defined as a treatment for NHL given after disease progression)
* Uncontrolled hypertension
* Known history of porphyria, G6PD deficiency, HIV
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pharmacyclics LLC.

INDUSTRY

Sponsor Role lead

Principal Investigators

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Brad Kahl, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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San Diego, California, United States

Site Status

Stanford, California, United States

Site Status

Miami, Florida, United States

Site Status

Chicago, Illinois, United States

Site Status

Baltimore, Maryland, United States

Site Status

Rochester, Minnesota, United States

Site Status

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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PCYC-0221

Identifier Type: -

Identifier Source: org_study_id