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

This study has been completed.
Sponsor:
Information provided by:
Pharmacyclics
ClinicalTrials.gov Identifier:
NCT00076401
First received: January 21, 2004
Last updated: April 2, 2009
Last verified: August 2004
History of Changes
  Purpose

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 Intervention Phase
Leukemia
Leukemia, Lymphocytic, Chronic
 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 Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

Resource links provided by NLM:

Drug Information available for: Gadolinium
U.S. FDA Resources

Further study details as provided by Pharmacyclics:

Estimated Enrollment: 27
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00076401

Locations
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States
Sponsors and Collaborators
Pharmacyclics
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00076401     History of Changes
Other Study ID Numbers: PCYC-0216
Study First Received: January 21, 2004
Last Updated: April 2, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pharmacyclics:
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, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Motexafin gadolinium
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Dermatologic Agents

ClinicalTrials.gov processed this record on May 16, 2013