Know Cancer

forgot password

Phase II Study of Campath-1H (NSC #950010) and Peripheral Blood Stem Cell Transplant for Patients With Chronic Lymphocytic Leukemia

Phase 2
18 Years
65 Years
Not Enrolling

Thank you

Trial Information

Phase II Study of Campath-1H (NSC #950010) and Peripheral Blood Stem Cell Transplant for Patients With Chronic Lymphocytic Leukemia


- Determine the ability of in vivo purging with alemtuzumab (monoclonal antibody CD52;
Campath-1H) to produce a stem cell graft without detectable leukemia cells in patients
with chronic lymphocytic leukemia.

- Determine the ability to successfully mobilize stem cells after in vivo purging with
monoclonal antibody CD52 in these patients.

- Determine the toxicity of this treatment regimen in these patients.

- Determine the response to this treatment regimen in these patients at 6 months after
peripheral blood stem cell transplantation.

OUTLINE: This is a multicenter study.

Patients receive induction therapy comprising alemtuzumab (monoclonal antibody CD52;
Campath-1H) IV over 2 hours three times a week for 4 weeks.

Beginning no more than 2 weeks after induction therapy, patients receive mobilization
chemotherapy comprising cyclophosphamide IV over 1-2 hours on day 1 and filgrastim (G-CSF)
subcutaneously (SC) starting on day 2 and continuing until the last day of apheresis.
Patients undergo peripheral blood stem cell apheresis on days 10-14.

Beginning 2-4 weeks after apheresis, patients receive a preparative regimen comprising
cyclophosphamide IV over 2 hours on days -5 and -4 and fractionated total body irradiation
twice a day over 6-10 hours on days -3 to -1. Patients undergo peripheral blood stem cell
transplantation on day 0. Patients receive G-CSF SC beginning on day 1 and continuing until
blood counts recover.

Patients are followed at 60 days, 1 year, and then annually thereafter until disease

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

Inclusion Criteria


- Diagnosis of chronic lymphocytic leukemia (CLL) that meets the following criteria at
any point prior to study entry:

- Peripheral blood absolute blood count greater than 5,000/mm^3

- Lymphocytosis must comprise small to moderate size lymphocytes with no more than
55% prolymphocytes, atypical lymphocytes, or lymphoblasts morphologically

- Phenotypically characterized B-cell CLL

- Splenomegaly, hepatomegaly, or lymphadenopathy not required for CLL diagnosis

- Must have bone marrow biopsy within 4 weeks of study entry showing cellularity of at
least 25% of intratrabecular space and lymphocytes accounting for no more than 30% of
nucleated cells



- 18 to 65

Performance status:

- ECOG 0-1

Life expectancy:

- Not specified


- See Disease Characteristics

- Absolute neutrophil count at least 1,000/mm^3

- Hemoglobin at least 11 g/dL

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 2 mg/dL (unless secondary to tumor)

- AST or ALT less than 3 times upper limit of normal

- Hepatitis B surface antigen negative

- Hepatitis C RNA negative


- Creatinine no greater than 2.0 mg/dL


- Left ventricular ejection fraction at least 45% by echocardiogram or MUGA


- DLCO, FEV_1, and FVC greater than 50% of predicted


- No active infection requiring oral or IV antibiotics

- No other prior malignancy within the past two years except basal cell skin cancer or
carcinoma in situ of the cervix

- HIV negative

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception


Biologic therapy:

- Prior monoclonal antibody CD52 allowed if at least partial remission was achieved
with last treatment


- No more than 2 prior chemotherapy regimens

- At least 3 weeks since prior chemotherapy

- No more than 8 courses of prior fludarabine therapy

Endocrine therapy:

- Not specified


- Not specified


- Not specified

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Ian W. Flinn, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

February 2001

Completion Date:

Related Keywords:

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



Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
CCOP - Northern New Jersey Hackensack, New Jersey  07601
Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey, Pennsylvania  17033-0850
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
Cancer Center at Tufts - New England Medical Center Boston, Massachusetts  02111
CCOP - Geisinger Clinic and Medical Center Danville, Pennsylvania  17822-2001
Abramson Cancer Center at the University of Pennsylvania Philadelphia, Pennsylvania  19104
Veterans Affairs Medical Center - Lakeside Chicago Chicago, Illinois  60611
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Hillman Cancer Center at University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15236
CCOP - Marshfield Clinic Research Foundation Marshfield, Wisconsin  54449
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611