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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Pharmacyclics
ClinicalTrials.gov Identifier:
NCT00100711
First received: January 4, 2005
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Drug: Motexafin Gadolinium
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pharmacyclics:

Primary Outcome Measures:
  • Complete and partial response rates

Secondary Outcome Measures:
  • Progression-free survival
  • Duration of response
  • Safety and tolerability

Estimated Enrollment: 27
Study Start Date: October 2004
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00100711

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Minnesota
The Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210-1240
Sponsors and Collaborators
Pharmacyclics
Investigators
Principal Investigator: Andrew Evens, D.O. Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Principal Investigator: Neil E. Kay, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Pharmacyclics
ClinicalTrials.gov Identifier: NCT00100711     History of Changes
Other Study ID Numbers: PCYC-0222
Study First Received: January 4, 2005
Last Updated: May 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pharmacyclics:
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

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Motexafin gadolinium
Antineoplastic Agents
Contrast Media
Dermatologic Agents
Diagnostic Uses of Chemicals
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014