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

Lymphoma Clinical Trial

Official title:

Phase II Trial of Motexafin Gadolinium (MGd) in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00086034
• Other study ID #: PCYC-0221
• Status: Completed
• Phase: Phase 2
• First received: June 21, 2004
• Last updated: May 11, 2007

Study information

• Verified date: May 2007
• Source: Pharmacyclics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• Motexafin gadolinium

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pharmacyclics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response rate
Secondary	Progression-free survival
Secondary	Duration of clinical response
Secondary	Safety and tolerability