NCT00100711

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2005

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Last Updated

May 23, 2014

Status Verified

May 1, 2014

Enrollment Period

5.3 years

First QC Date

January 4, 2005

Last Update Submit

May 7, 2014

Conditions

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

Keywords

Chronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaLeukemiaLymphomaMotexafin GadoliniumRelapsed Chronic Lymphocytic LeukemiaRelapsed Chronic Lymphocycic LymphomaRefractory Chronic Lymphocytic LeukemiaRefractory Small Lymphocytic Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Complete and partial response rates

Secondary Outcomes (3)

  • Progression-free survival

  • Duration of response

  • Safety and tolerability

Interventions

Motexafin GadoliniumDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Northwestern University

Chicago, Illinois, 60611, United States

Location

The Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

The Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-CellLeukemiaLymphoma

Interventions

motexafin gadolinium

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Andrew Evens, D.O.

    Robert H. Lurie Comprehensive Cancer Center of Northwestern University

    PRINCIPAL INVESTIGATOR

  • Neil E. Kay, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2005

First Posted

January 5, 2005

Study Start

October 1, 2004

Primary Completion

February 1, 2010

Last Updated

May 23, 2014

Record last verified: 2014-05

Locations

US(3)