Phase II Study of Campath-1H (NSC #950010) and Peripheral Blood Stem Cell Transplant for Patients With Chronic Lymphocytic Leukemia
18 Years
65 Years
Both
Leukemia
Trial Information
Phase II Study of Campath-1H (NSC #950010) and Peripheral Blood Stem Cell Transplant for Patients With Chronic Lymphocytic Leukemia
OBJECTIVES:
- 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
progression.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- 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
PATIENT CHARACTERISTICS:
Age:
- 18 to 65
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- 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
Hepatic:
- 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
Renal:
- Creatinine no greater than 2.0 mg/dL
Cardiovascular:
- Left ventricular ejection fraction at least 45% by echocardiogram or MUGA
Pulmonary:
- DLCO, FEV_1, and FVC greater than 50% of predicted
Other:
- 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
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Prior monoclonal antibody CD52 allowed if at least partial remission was achieved
with last treatment
Chemotherapy:
- 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
Radiotherapy:
- Not specified
Surgery:
- Not specified
Type of Study:
Interventional
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
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000068272
NCT ID:
NCT00006390
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
Name | Location |
|---|---|
| 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 |
