Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 18 and over Pharmaceutical / Industry PCYC-0221 NCT00086034

Trial Description

Summary

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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Pharmacyclics, Incorporated

Brad Kahl, MD

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00086034
Information obtained from ClinicalTrials.gov on May 27, 2008