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Phase 1
18 Years
Not Enrolling
Chronic Lymphocytic Leukemia

Thank you

Trial Information

Inclusion Criteria:

1. Relapsed or refractory chronic lymphocytic leukemia.

2. Patients must have either intermediate or high risk chronic lymphocytic leukemia
according to the Rai Staging System.

3. Must have failed at least 1 prior chemotherapy regimen (at least 1 of which included
fludarabine) for CLL.

4. No prior therapy within 4 weeks prior to entering the study. Patients must have fully
recovered from the acute effects of prior therapy.

5. Platelet count = 75,000/mm3 , hemoglobin = 8 gm/dL.

6. Expected remaining life span > or = three months.

7. ECOG performance status 0 - 2.

8. 18 years or of legal age.

9. Male patients or non-pregnant and non-lactating female patients, who are either using
adequate birth control, are surgically sterile or post-menopausal.

10. Negative serum pregnancy test, if fertile female.

11. Willingness and ability to sign an informed consent document.

Exclusion Criteria:

1. Evidence of CNS involvement.

2. Other active malignancy or history of treatment of any malignancy (excluding
non-melanoma skin cancer) within the previous three years.

3. Previous therapy with Campath.

4. Patients with low-risk chronic lymphocytic leukemia according to the Rai Staging

5. Concurrent immunotherapy.

6. Concurrent use of steroids.

7. Use of an investigational medication or device within 1 month of initiating study

8. Patients who have had allogeneic bone marrow transplantation.

9. Total serum bilirubin above the upper limit of normal; serum creatinine above the
upper limit of normal.

10. AST or ALT > 2.5 times the upper limit of normal.

11. Any condition or any medication which may interfere with the conduct of the study.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

March 2002

Completion Date:

April 2003

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Chronic Lymphocytic Leukemia
  • Leukemia
  • CLL
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid



Albany Regional Cancer Center Albany, New York  12208
Tyler Cancer Center Tyler, Texas  75702
Cancer Care Northwest Spokane, Washington  99202
Cancer Centers of Florida Orlando, Florida  32806
Mary Crowley Medical Research Center (US Oncology) Dallas, Texas  75246