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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma, Non-Hodgkin's Lymphoma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Clinical response rate

Principal Investigator

Brad Kahl, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Food and Drug Administration

Study ID:

PCYC-0221

NCT ID:

NCT00086034

Start Date:

Completion Date:

Related Keywords:

  • Lymphoma
  • Non-Hodgkin's Lymphoma
  • Lymphoma
  • Non-Hodgkin's Lymphoma
  • Indolent lymphoma
  • Relapsed lymphoma
  • Refractory lymphoma
  • Motexafin gadolinium
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Hinsdale, Illinois  60521
Alexandria, Minnesota  56308
Fountain Valley, California  92708
Miami, Florida  33176
Baltimore, Maryland  21287
Milwaukee, Wisconsin