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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

January 4, 2005
May 7, 2014
October 2004
February 2010   (final data collection date for primary outcome measure)
Complete and partial response rates
Not Provided
Complete list of historical versions of study NCT00100711 on ClinicalTrials.gov Archive Site
  • Progression-free survival
  • Duration of response
  • Safety and tolerability
Not Provided
Not Provided
Not Provided
 
Study of Motexafin Gadolinium (MGd) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Phase II Trial of Motexafin Gadolinium (MGd) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma With Refractory or Relapsed Disease

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
Drug: Motexafin Gadolinium
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
27
Not Provided
February 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00100711
PCYC-0222
Not Provided
Pharmacyclics
Pharmacyclics
Not Provided
Principal Investigator: Andrew Evens, D.O. Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Principal Investigator: Neil E. Kay, MD Mayo Clinic
Pharmacyclics
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP