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A Study of Motexafin Gadolinium for the Treatment of Chronic Lymphocytic Leukemia (CLL)

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ClinicalTrials.gov Identifier: NCT00076401
Recruitment Status : Terminated
First Posted : January 26, 2004
Last Update Posted : June 26, 2014
Sponsor:
Information provided by (Responsible Party):
Pharmacyclics LLC.

Brief Summary:
The purpose of this study is to determine if the drug motexafin gadolinium will be an effective treatment for patients who have chronic lymphocytic leukemia (CLL) that has come back after treatment or that has stopped responding to treatment.

Condition or disease Intervention/treatment Phase
Leukemia Leukemia, Lymphocytic, Chronic Drug: Motexafin gadolinium Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Motexafin Gadolinium (MGd) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)






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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years old
  • Refractory or relapsed CLL
  • ECOG performance status score of 0, 1, or 2
  • Each patient must sign a study-specific informed consent form

Exclusion Criteria:

Laboratory values of:

  • Platelet count <30,000/uL
  • AST or ALT >2 x the upper limit of normal (ULN)
  • Total bilirubin >2 x ULN
  • Creatinine >2.0 mg/dL
  • Chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids, or systemic biologic anticancer therapy within 21 days before beginning study treatment
  • Women who are pregnant or lactating

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00076401


Locations
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States
Sponsors and Collaborators
Pharmacyclics LLC.

Responsible Party: Pharmacyclics LLC.
ClinicalTrials.gov Identifier: NCT00076401     History of Changes
Other Study ID Numbers: PCYC-0216
First Posted: January 26, 2004    Key Record Dates
Last Update Posted: June 26, 2014
Last Verified: June 2014

Keywords provided by Pharmacyclics LLC.:
CLL
chronic lymphocytic leukemia
relapsed chronic lymphocytic leukemia
refractory chronic lymphocytic leukemia
Leukemia
Motexafin gadolinium
Chronic leukemia
Lymphocytic leukemia, chronic

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Motexafin gadolinium
Antineoplastic Agents
Photosensitizing Agents
Dermatologic Agents