Alemtuzumab Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia - Full Text View

Sponsors and Collaborators:	Eastern Cooperative Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00006390

Purpose

RATIONALE: Monoclonal antibodies such as alemtuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy.

Combining monoclonal antibody therapy, chemotherapy, radiation therapy, and peripheral stem cell transplantation may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of alemtuzumab plus peripheral stem cell transplantation in treating patients who have chronic lymphocytic leukemia.

Condition	Intervention	Phase
Leukemia	Biological: alemtuzumab Biological: filgrastim Drug: cyclophosphamide Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy	Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Radiation Therapy

Drug Information available for: Cyclophosphamide Filgrastim Campath Alemtuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Phase II Study of Campath-1H (NSC #950010) and Peripheral Blood Stem Cell Transplant for Patients With Chronic Lymphocytic Leukemia

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:	February 2001
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006390

Locations

United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, United States, 60611-4494
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Cancer Center at Tufts - New England Medical Center
Boston, Massachusetts, United States, 02111
United States, Minnesota
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United States, New Jersey
CCOP - Northern New Jersey
Hackensack, New Jersey, United States, 07601
United States, Pennsylvania
Abramson Cancer Center at the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States, 17822-2001
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15236
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
United States, Wisconsin
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States, 54449
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-0001

Sponsors and Collaborators

Eastern Cooperative Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Ian W. Flinn, MD, PhD

Sidney Kimmel Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000068272, ECOG-8998
Study First Received:	October 4, 2000
Last Updated:	February 4, 2009
ClinicalTrials.gov Identifier:	NCT00006390 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Leukemia, Lymphoid
Immunoproliferative Disorders
Immunologic Factors
Cyclophosphamide
Immunosuppressive Agents
Leukemia
Lymphatic Diseases
Chronic Lymphocytic Leukemia

Leukemia, Lymphocytic, Chronic, B-Cell
Alemtuzumab
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Leukemia, B-Cell
Lymphoproliferative Disorders
Leukemia, B-cell, Chronic
Alkylating Agents

Additional relevant MeSH terms:

Leukemia, Lymphoid
Neoplasms by Histologic Type
Immunoproliferative Disorders
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Cyclophosphamide
Immunosuppressive Agents
Pharmacologic Actions
Leukemia

Lymphatic Diseases
Neoplasms
Leukemia, Lymphocytic, Chronic, B-Cell
Therapeutic Uses
Alemtuzumab
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Leukemia, B-Cell
Lymphoproliferative Disorders
Alkylating Agents

ClinicalTrials.gov processed this record on May 06, 2009