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A Prospective, Randomized, Open Label, Phase III Trial of Fludarabine, Cyclophosphamide, and Rituximab vs. Pentostatin, Cyclophosphamide, and Rituximab in Previously Untreated or Treated B-Cell Chronic Lymphocytic Leukemia

Phase 3
18 Years
Open (Enrolling)
B-Cell Chronic Lymphocytic Leukemia

Thank you

Trial Information

A Prospective, Randomized, Open Label, Phase III Trial of Fludarabine, Cyclophosphamide, and Rituximab vs. Pentostatin, Cyclophosphamide, and Rituximab in Previously Untreated or Treated B-Cell Chronic Lymphocytic Leukemia

Inclusion Criteria


Patients will be eligible for inclusion in this study if they meet all of the following

- Progressive, histologically proven B-cell CLL.

- Stage II, III, or IV B-cell CLL, as defined by Appendix III.

Note: The pathology or flow cytometry (of peripheral blood or a bone marrow) report, done
by the local laboratory which documents these findings, must be included in the source
documents. The SI must review the above pathology report or flow cytometry report results
(including bone marrow aspirate analysis and CD5 and CD20 results) by fax, prior to
registration, to confirm each patient's eligibility. Results should be consistent with
typical B-cell CLL. If Dr. Reynolds is not available to review these documents, they must
be reviewed by Dr. Nicholas J. Di Bella.

- Patient must be CD20 +

- Patient must be CD5+ (CD5 >70%)

- No more than 1 prior course (regimen) of chemotherapy, which can include Fludara or

- No prior radiation therapy, except for the treatment of skin cancer or a nonmalignant

- If patient has lymph node involvement, a CT scan confirming measurable tumor size
(lymph node must be >1 cm in its longest transverse diameter).

- SI has been notified IF patient is on replacement steroids at time of registration.

- Age greater than 18 years.

- ECOG performance status of 0-2 (Appendix I).

- Normal renal function (creatinine <1.5 mg/dL and BUN <25 mg/dL).

- Absolute neutrophil count (ANC) greater than 1,000 cells/µL, platelet count greater
than 50,000 cells/µL, and hemoglobin greater than 9 g/dL.

- Bilirubin less than 2.0 mg/dL, and AST and ALT less than 5 times the upper limit of

- Negative serum pregnancy test within 7 days prior to registration (female patients of
childbearing potential).

- Agrees to use an acceptable method of birth control, if fertile patient (male or
female), to avoid pregnancy for the duration of the study and for at least 3 months

- A signed Patient Informed Consent Form has been obtained.

- A signed Patient Authorization Form has been obtained.


Patients will be excluded from this study if they meet any of the following criteria:

- Any disease other than histologically confirmed progressive, Stage II, III, or IV

- Well differentiated lymphocytic lymphoma in nodes without lymphocytosis.

- More than 1 prior course (regimen) of chemotherapy.

- Any radiation for the treatment of CLL.

- Any prior Nipent.

- Known to be CD20 negative (CD20 <20%).

- Pregnant or lactating, or has a positive pregnancy test.

- Has a history of other malignancy (other than in situ cervical cancer, carcinoma
intraepithelial neoplasia, or non-melanoma skin cancer) within the last 5 years,
which could affect the administration of these study drugs or assessment of current

- Known to be HIV positive.

- Uncontrolled thyroid disease or uncontrolled abnormal thyroid function.

Note: Patients with thyroid disease that is controlled with medication may participate.

- A history of recent, unstable organic heart disease or stable organic heart disease
with LVEF <50%.

- A known hypersensitivity to Fludara, Nipent, Rituxan, or Cytoxan, or any component of
these drugs.

- Autoimmune hemolytic anemia.

- Unable to comply with requirements of study.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Craig Reynolds, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

US Oncology Research


United States: Institutional Review Board

Study ID:




Start Date:

December 2003

Completion Date:

Related Keywords:

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



Hope Center Terre Haute, Indiana  47809
Cancer Centers of Florida, P.A. Orlando, Florida  
Medical Oncology Associates Kingston, Pennsylvania  18704
New York Oncology Hematology, PC Albany, New York  12208
South Texas Cancer Center-McAllen McAllen, Texas  78503
Texas Oncology Cancer Center-Sugar Land Sugar Land, Texas  77479
Cancer Care Northwest-South Spokane, Washington  99202
Yakima Valley Mem Hosp/North Star Lodge Yakima, Washington  98902
Alliance Hematology Oncology PA Westminster, Maryland  21157
St Joseph Oncology, Inc St Joseph, Missouri  64507
Northwestern Carolina Oncology Hemato Hickory, North Carolina  28602