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

Phase 2

Completed

• Conditions: Lymphoma; Non-Hodgkin's Lymphoma

• Registration Number: NCT00086034
• Lead Sponsor: Pharmacyclics LLC.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2004-06-21
• Study First Submitted QC: 2004-06-22
• Study First Posted: 2004-06-23
• Status Verified: 2007-05
• Last Update Submitted: 2007-05-11
• Last Update Posted: 2007-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Clinical response rate

Secondary Outcome Measures

Name	Time	Method
Progression-free survival
Duration of clinical response
Safety and tolerability