Study of Motexafin Gadolinium (MGd) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Sponsor

Pharmacyclics LLC. (Industry)

Overall Status

Terminated

CT.gov ID

NCT00100711

Collaborator

(none)

Enrollment

Locations

Patients Per Site

Study Details

Study Description

Brief Summary

The primary purpose of this study is to determine if motexafin gadolinium may be an effective treatment for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Secondly, the duration of response and the time during which patients survive without chronic lymphocytic leukemia or small lymphocytic lymphoma worsening will be evaluated. Additionally, the patient's response to motexafin gadolinium will be compared to the response of the patient's cells in a laboratory to motexafin gadolinium.

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma	Drug: Motexafin Gadolinium	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2004

Actual Primary Completion Date :

Feb 1, 2010

Outcome Measures

Primary Outcome Measures

Complete and partial response rates []

Secondary Outcome Measures

Progression-free survival []
Duration of response []
Safety and tolerability []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University	Chicago	Illinois	United States	60611
2	The Mayo Clinic	Rochester	Minnesota	United States	55905
3	The Ohio State University	Columbus	Ohio	United States	43210-1240

Sponsors and Collaborators

Pharmacyclics LLC.

Investigators

Principal Investigator: Andrew Evens, D.O., Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Principal Investigator: Neil E. Kay, MD, Mayo Clinic