Phase II Trial of Motexafin Gadolinium (MGd) in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
Data Collection
Immune System Diseases+5
+ Immunoproliferative Disorders
+ Lymphatic Diseases
Treatment Study
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.35 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives