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

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00100711
• Other study ID #: PCYC-0222
• Status: Terminated
• Phase: Phase 2
• First received: January 4, 2005
• Last updated: May 7, 2014
• Start date: October 2004

Study information

• Verified date: May 2014
• Source: Pharmacyclics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma
• Small Lymphocytic Lymphoma

Intervention

Drug:
• Motexafin Gadolinium

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	The Ohio State University	Columbus	Ohio
United States	The Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Pharmacyclics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete and partial response rates
Secondary	Progression-free survival
Secondary	Duration of response
Secondary	Safety and tolerability