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Phase II Trial of Motexafin Gadolinium (MGd) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma With Refractory or Relapsed Disease


Phase 2
18 Years
N/A
Not Enrolling
Both
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Thank you

Trial Information

Phase II Trial of Motexafin Gadolinium (MGd) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma With Refractory or Relapsed Disease


Inclusion Criteria:



- ≥ 18 years old

- CLL as defined by the NCI 96 criteria (exception; patients may have bright surface
immunoglobulin staining if negative for t[11;14] translocation or cyclin D1) or SLL
as defined by WHO classification criteria and is refractory or relapsed as defined by
one of the following: 1) Refractory disease- progressive disease while on therapy, or
2) Relapsed disease progressive disease after at least one treatment course of
therapy with disease response or stabilization

- ECOG performance status score of 0, 1, or 2

- Willing and able to provide written informed consent

Exclusion Criteria:

Laboratory Values of:

- Platelet count < 30,000/µL

- AST or ALT > 2 x ULN (upper limit of normal)

- Total bilirubin > 2 x ULN

- Creatinine > 2.0 mg/dL

and

- Chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids (> 10 mg
oral prednisone or equivalent), or systemic biologic anticancer therapy within 21
days before beginning study treatment

- Greater than three prior regimens (where a regimen is defined as a treatment for
CLL/SLL given initially or after disease progression)

- Uncontrolled hypertension

- Known history of porphyria (testing not required at screening)

- Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency (testing not
required at screening)

- Known history of HIV infection (testing not required at screening)

- Pregnant or lactating (pregnancy test is required for all female patients of
childbearing potential)

- Woman of childbearing potential or sexually active man unwilling to use adequate
contraceptive protection

- Physical or mental condition that makes patient unable to complete specified
follow-up assessments

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:

Complete and partial response rates

Principal Investigator

Andrew Evens, D.O.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Authority:

United States: Food and Drug Administration

Study ID:

PCYC-0222

NCT ID:

NCT00100711

Start Date:

October 2004

Completion Date:

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
  • Leukemia
  • Lymphoma
  • Motexafin Gadolinium
  • Relapsed Chronic Lymphocytic Leukemia
  • Relapsed Chronic Lymphocycic Lymphoma
  • Refractory Chronic Lymphocytic Leukemia
  • Refractory Small Lymphocytic Lymphoma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma

Name

Location

Northwestern UniversityChicago, Illinois  60611
The Ohio State UniversityColumbus, Ohio  43210
The Mayo ClinicRochester, Minnesota  55905