Know Cancer

forgot password

Phase 2
18 Years
Open (Enrolling)
Chronic Lymphocytic Leukemia

Thank you

Trial Information

Inclusion Criteria


- Men or women ≥18 years of age

- Histopathologically confirmed diagnosis of B-CLL expressing surface CD20 of any
detectable intensity

- Rai Stage III or IV. Rai Stages I and II with massive or progressive lymphadenopathy
or hepatosplenomegaly.

- Primary resistance to a fludarabine regimen (no PR or CR) or progressive disease
within 1 year of a prior response

- ECOG performance status 0, 1, or 2

- Written informed consent


- Therapy for CLL within 4 weeks of Study Day 1 (including chemotherapy, radiation,
immunotherapy, cytokine or biologic [with the exception of hematopoietic growth
factors]). Patients must have recovered from the adverse effects of prior therapy.

- Known primary or secondary malignancy of the central nervous system

- Any malignancy within the 5 years immediately prior to the first dose of study
medication with the exception of basal cell or non-metastatic squamous cell carcinoma
of the skin, and carcinoma in-situ of the cervix

- Serum creatinine >2.0mg/dL (>176 micromol/L)

- AST or ALT ≥3 x the upper limit of normal (ULN)

- Total bilirubin ≥1.5 x ULN (unless secondary to Gilbert’s)

- Positive serology for hepatitis B (HBsAg) or hepatitis C (anti-HCV antibody)

- Known positivity for HIV

- Prior organ allograft

- Concurrent comorbid medical conditions that, in the opinion of the investigator,
preclude the safe delivery of the experimental treatment

- Pregnant or nursing women

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

Completion Date:

Related Keywords:

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



MD Anderson Cancer Center Houston, Texas  77030-4096
Long Island Jewish Medical Center New Hyde Park, New York  11040
Ocala Oncology Center Ocala, Florida  34474
Cancer Centers of the Carolinas Greenville, South Carolina  29605
Queens Medical Associates, PC Fresh Meadows, New York  11365
Dana Farber Cancer Institute Boston, Massachusetts  02115
NYU Medical Center New York, New York  10016
University of Arkansas for Medical Science Little Rock, Arkansas  72205
Nevada Cancer Institute Las Vegas, Nevada  89135
Wake Forest University Health Sciences Winston-Salem, North Carolina  27157
Gulfcoast Oncology Associates St. Petersburg, Florida  33705
Indiana Oncology/Hematology Consultants Indianapolis, Indiana  46202
Hematology/Oncology Centers of the Northern Rockies Billings, Montana  59101
James P. Wilmot Cancer Center/University of Rochester Rochester, New York  14642
Raleigh Hematology/Oncology Clinic Cary, North Carolina  27511
Cancer Care Associates/Oklahoma City Oklahoma City, Oklahoma  73112
Cancer Care Associates--Tulsa Tulsa, Oklahoma  74136
Texas Cancer Center/Abilene Abilene, Texas  79606-5208
Virginia Oncology Associates-Lake Wright Cancer Center Norfolk, Virginia  23502