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Completed

NCT Number: NCT00086034

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

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.

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Key information

Conditions

Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Non-Hodgkin's Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

San Diego, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

motexafin gadolinium

Drug

Primary outcomes

  1. Clinical response rate

Secondary outcomes

  1. Progression-free survival

  2. Duration of clinical response

  3. Safety and tolerability

Sponsors and collaborators

Lead sponsor

Pharmacyclics LLC.

Industry

Registry information

Official study title

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

Important dates

First posted
Jun 23, 2004
Registry last updated
May 15, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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