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| ID | Type | Description | Link |
|---|---|---|---|
| ECOG-8998 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alemtuzumab | Biological | |||
| filgrastim | Biological | |||
| cyclophosphamide | Drug | |||
| peripheral blood stem cell transplantation | Procedure | |||
| radiation therapy | Radiation |
DISEASE CHARACTERISTICS:
Diagnosis of chronic lymphocytic leukemia (CLL) that meets the following criteria at any point prior to study entry:
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:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Ian W. Flinn, MD, PhD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Affairs Medical Center - Lakeside Chicago | Chicago | Illinois | 60611-4494 | United States | ||
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University |
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| Chicago |
| Illinois |
| 60611 |
| United States |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231 | United States |
| Cancer Center at Tufts - New England Medical Center | Boston | Massachusetts | 02111 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | 55416 | United States |
| CCOP - Northern New Jersey | Hackensack | New Jersey | 07601 | United States |
| CCOP - Geisinger Clinic and Medical Center | Danville | Pennsylvania | 17822-2001 | United States |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | United States |
| Abramson Cancer Center at the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111-2497 | United States |
| Hillman Cancer Center at University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | 15236 | United States |
| University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin | 53792-0001 | United States |
| CCOP - Marshfield Clinic Research Foundation | Marshfield | Wisconsin | 54449 | United States |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000074323 | Alemtuzumab |
| D000069585 | Filgrastim |
| D003520 | Cyclophosphamide |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D001685 | Biological Factors |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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