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A Phase II Study of Fludarabine Induction Followed by CAMPATH-1H Consolidation in Untreated Patients With B-Cell Chronic Lymphocytic Leukemia

Phase 2
18 Years
Open (Enrolling)

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Trial Information

A Phase II Study of Fludarabine Induction Followed by CAMPATH-1H Consolidation in Untreated Patients With B-Cell Chronic Lymphocytic Leukemia

OBJECTIVES: I. Determine the overall response rate of previously untreated patients with
stage I, II, III, or IV B-cell chronic lymphocytic leukemia when treated with fludarabine
induction followed by alemtuzumab consolidation. II. Determine the infectious toxic effects
and feasibility of this regimen in this patient population. III. Determine the
treatment-related toxic effects, including infection and injection site reactions, of
subcutaneous vs intravenous alemtuzumab in patients treated with this regimen. IV. Determine
the progression-free and overall survival of patients treated with this regimen. V.
Determine the immunologic effects of this regimen in these patients.

OUTLINE: Patients receive fludarabine IV over 30 minutes 5 days a week. Treatment repeats
every 28 days for 4 courses in the absence of disease progression. Patients undergo clinical
staging after completion of course 4 of fludarabine followed by 2 months of observation.
Patients with stable or responding disease receive alemtuzumab subcutaneously 3 days a week
for 6 weeks. Patients undergo clinical staging again after completion of 6 weeks of
alemtuzumab followed by 2 more months of observation. Patients are followed every 3 months
for 1 year and then every 6 months for 8 years.

PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study within 1 year.

Inclusion Criteria

DISEASE CHARACTERISTICS: Previously untreated, stage I, II, III, or IV B-cell chronic
lymphocytic leukemia (CLL) Lymphocytosis greater than 5,000/mm3 with less than 55%
prolymphocytes Bone marrow aspirate with greater than 30% of all nucleated cells being
lymphoid OR Bone marrow core biopsy must show lymphoid infiltrates compatible with marrow
involvement by CLL Overall cellularity must be normocellular or hypercellular Monoclonal
B-cell population positive for at least 1 B-lineage marker (CD19, CD20, CD23, CD24) with
coexpression of CD5 Bright surface immunoglobulin levels must have CD23 coexpression Stage
I or II disease must have evidence of active disease demonstrated by at least 1 of the
following: Massive or progressive splenomegaly and/or lymphadenopathy Presence of weight
loss greater than 10% over the preceding 6-month period Grade 2 or 3 fatigue Fevers
greater than 100.5 degrees Fahrenheit or night sweats for greater than 2 weeks without
evidence of infection Progressive lymphocytosis with an increase of greater than 50% over
a 2-month period or an anticipated doubling time of less than 6 months

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 0-2 Life expectancy: Not
specified Hematopoietic: Direct Coomb's test negative Hepatic: Not specified Renal:
Creatinine no greater than 1.5 times upper limit of normal Other: Not pregnant or nursing
Fertile patients must use effective contraception No medical condition requiring chronic
oral corticosteroids

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for CLL No
concurrent epoetin alfa Chemotherapy: No prior chemotherapy for CLL No other concurrent
chemotherapy Endocrine therapy: No prior corticosteroids for autoimmune complications that
have developed since initial diagnosis of CLL No concurrent hormones except steroids for
new adrenal failure or nondisease-related conditions (e.g., insulin for diabetes) No
concurrent dexamethasone or other corticosteroid-based antiemetics Radiotherapy: No
concurrent palliative radiotherapy Surgery: Not specified

Type of Study:


Study Design:

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

Outcome Measure:


Outcome Time Frame:

2 months post consolidation

Safety Issue:


Principal Investigator

Kanti R. Rai, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Long Island Jewish Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

January 2000

Completion Date:

March 2012

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



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Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore, Maryland  21201
Ellis Fischel Cancer Center - Columbia Columbia, Missouri  65203
Barnes-Jewish Hospital Saint Louis, Missouri  63110
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