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`A Phase II Study of Alternating Cycles of Fludarabine and Cyclophosphamide in Previously Untreated Patients With B-Cell CLL

Phase 2
18 Years
Not Enrolling

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Trial Information

`A Phase II Study of Alternating Cycles of Fludarabine and Cyclophosphamide in Previously Untreated Patients With B-Cell CLL

OBJECTIVES: I. Determine the rate and duration of complete and partial remissions in
patients with previously untreated B-cell chronic lymphocytic leukemia after treatment with
alternating courses of fludarabine and cyclophosphamide. II. Monitor and assess toxicity of
this regimen in these patients. III. Utilize molecular genetic studies and flow cytometry on
peripheral blood cells from patients achieving complete remission by conventional criteria.
IV. Apply FISH techniques using probes to chromosomes 12 and 13 as prognostic factors for
time to progression and overall survival of these patients.

OUTLINE: Patients receive alternating courses of fludarabine and cyclophosphamide.
Fludarabine is administered IV over 10-30 minutes on days 1-5 of courses 1, 3, and 5.
Cyclophosphamide is administered IV over 30-60 minutes on day 1 of courses 2, 4, and 6.
Treatment repeats every 4 weeks. Patients achieving clinical complete remission (CCR) after
6 courses of chemotherapy receive 2 additional courses (one course of each drug). Patients
achieving partial remission after 6 courses of chemotherapy also receive 2 additional
courses. If these patients then achieve CCR, they receive another 2 courses. Patients are
followed every 3 months.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 22 months.

Inclusion Criteria

DISEASE CHARACTERISTICS: Diagnosis of B-cell chronic lymphocytic leukemia (CLL) manifested
by all of the following: Threshold peripheral lymphocyte count greater than 5000/mm3 Small
to moderate peripheral lymphocytes with no greater than 55% prolymphocytes Peripheral
lymphocyte count less than 15,000/mm3 At least 30% lymphoid cells in bone marrow
Monoclonality of B lymphocytes Active disease by at least one of the following criteria:
Weight loss of at least 10% within the past 6 months or prolonged fever or night sweats
without evidence of infection Progressive marrow failure (stage III or IV disease)
manifested by Hemoglobin less than 11 g/dL (anemia) AND/OR Platelet count less than
100,000/mm3 (thrombocytopenia) Autoimmune anemia and/or thrombocytopenia minimally
responsive to corticosteroid therapy Massive or progressive splenomegaly Massive or
progressive lymphadenopathy Progressive lymphocytosis (not due to the effects of
corticosteroids) Marked hypogammaglobulinemia or development of monoclonal protein in the
absence of any of the above criteria is not sufficient for eligibility

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater
than 1.5 times upper limit of normal (ULN) SGOT no greater than 1.5 times ULN (unless due
to hemolysis or CLL) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No
New York Heart Association class III or IV heart disease No myocardial infarction in the
past month Other: No uncontrolled infection No active infection with HIV (AIDS) No other
malignancy within past 2 years except nonmelanomatous skin cancer or carcinoma in situ of
the cervix Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior interferon allowed Chemotherapy: No
prior cytotoxic chemotherapy Endocrine therapy: See Disease Characteristics Prior
corticosteroids, somatostatin analogues, and tamoxifen allowed Radiotherapy: At least 4
weeks since prior radiotherapy Surgery: At least 4 weeks since prior major surgery

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Thomas E. Witzig, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

August 1999

Completion Date:

Related Keywords:

  • Leukemia
  • stage I chronic lymphocytic leukemia
  • stage II chronic lymphocytic leukemia
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • B-cell chronic lymphocytic leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid



Mayo Clinic Cancer Center Rochester, Minnesota  55905
CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
CCOP - Duluth Duluth, Minnesota  55805
CCOP - Scottsdale Oncology Program Scottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology Project Cedar Rapids, Iowa  52403-1206
Siouxland Hematology-Oncology Sioux City, Iowa  51101-1733
CentraCare Clinic Saint Cloud, Minnesota  56303
Quain & Ramstad Clinic, P.C. Bismarck, North Dakota  58501
Altru Health Systems Grand Forks, North Dakota  58201
Rapid City Regional Hospital Rapid City, South Dakota  57709
CCOP - Sioux Community Cancer Consortium Sioux Falls, South Dakota  57105-1080