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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
N/A
Open (Enrolling)
Both
Leukemia

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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:

Interventional

Study Design:

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

Outcome Measure:

Response

Outcome Time Frame:

2 months post consolidation

Safety Issue:

No

Principal Investigator

Kanti R. Rai, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Long Island Jewish Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000067506

NCT ID:

NCT00004857

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

Name

Location

Roswell Park Cancer Institute Buffalo, New York  14263
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
University of Chicago Cancer Research Center Chicago, Illinois  60637
University of Massachusetts Memorial Medical Center Worcester, Massachusetts  01655
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
Medical University of South Carolina Charleston, South Carolina  29425-0721
Rhode Island Hospital Providence, Rhode Island  02903
Vermont Cancer Center Burlington, Vermont  05401-3498
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
University of California San Diego Cancer Center La Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
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
Norris Cotton Cancer Center Lebanon, New Hampshire  03756
CCOP - North Shore University Hospital Manhasset, New York  11030
State University of New York - Upstate Medical University Syracuse, New York  13210
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer Center Memphis, Tennessee  38103
MBCCOP - Massey Cancer Center Richmond, Virginia  23298-0037
Mount Sinai Medical Center, NY New York, New York  10029
New York Presbyterian Hospital - Cornell Campus New York, New York  10021
Holden Comprehensive Cancer Center at The University of Iowa Iowa City, Iowa  52242-1009
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Lombardi Cancer Center Washington, District of Columbia  20007
Veterans Affairs Medical Center - Birmingham Birmingham, Alabama  35233
CCOP - Southwestern Vermont Regional Cancer Center Bennington, Vermont  05201
Veterans Affairs Medical Center - White River Junction White River Junction, Vermont  05009
Dana-Farber Cancer Institute Boston, Massachusetts  02115
North Shore University Hospital Manhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital) Chicago, Illinois  60612
Veterans Affairs Medical Center - San Francisco San Francisco, California  94121
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse, New York  13217
Veterans Affairs Medical Center - Memphis Memphis, Tennessee  38104
Veterans Affairs Medical Center - Richmond Richmond, Virginia  23249
University of Illinois at Chicago Health Sciences Center Chicago, Illinois  60612
Veterans Affairs Medical Center - Togus Togus, Maine  04330
Veterans Affairs Medical Center - Minneapolis Minneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial) Columbia, Missouri  65201
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Veterans Affairs Medical Center - Buffalo Buffalo, New York  14215
Veterans Affairs Medical Center - Syracuse Syracuse, New York  13210
Veterans Affairs Medical Center - Durham Durham, North Carolina  27705
Long Island Jewish Medical Center New Hyde Park, New York  11040