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

Primary Purpose

Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Motexafin Gadolinium
Sponsored by
Pharmacyclics LLC.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Northwestern University
  • The Mayo Clinic
  • The Ohio State University

Outcomes

Primary Outcome Measures

Complete and partial response rates

Secondary Outcome Measures

Progression-free survival
Duration of response
Safety and tolerability

Full Information

First Posted
January 4, 2005
Last Updated
May 7, 2014
Sponsor
Pharmacyclics LLC.
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1. Study Identification

Unique Protocol Identification Number
NCT00100711
Brief Title
Study of Motexafin Gadolinium (MGd) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
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 Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Study Start Date
October 2004 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmacyclics LLC.

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Motexafin Gadolinium
Primary Outcome Measure Information:
Title
Complete and partial response rates
Secondary Outcome Measure Information:
Title
Progression-free survival
Title
Duration of response
Title
Safety and tolerability

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Evens, D.O.
Organizational Affiliation
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Neil E. Kay, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
The Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States

12. IPD Sharing Statement

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

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