Back to resultsAlemtuzumab Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia
Primary Purpose
Leukemia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
alemtuzumab
filgrastim
cyclophosphamide
peripheral blood stem cell transplantation
radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia focused on measuring 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
Eligibility 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
Sites / Locations
- Veterans Affairs Medical Center - Lakeside Chicago
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Cancer Center at Tufts - New England Medical Center
- Beth Israel Deaconess Medical Center
- CCOP - Metro-Minnesota
- CCOP - Northern New Jersey
- CCOP - Geisinger Clinic and Medical Center
- Penn State Cancer Institute at Milton S. Hershey Medical Center
- Abramson Cancer Center at the University of Pennsylvania
- Fox Chase Cancer Center
- Hillman Cancer Center at University of Pittsburgh Cancer Institute
- University of Wisconsin Comprehensive Cancer Center
- CCOP - Marshfield Clinic Research Foundation
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00006390
First Posted
October 4, 2000
Last Updated
June 21, 2023
Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00006390
Brief Title
Alemtuzumab Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia
Official Title
Phase II Study of Campath-1H (NSC #950010) and Peripheral Blood Stem Cell Transplant for Patients With Chronic Lymphocytic Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 5, 2001 (Actual)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
alemtuzumab
Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian W. Flinn, MD, PhD
Organizational Affiliation
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Official's Role
Study Chair
Facility Information:
Facility Name
Veterans Affairs Medical Center - Lakeside Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-4494
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Cancer Center at Tufts - New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
CCOP - Northern New Jersey
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
CCOP - Geisinger Clinic and Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-2001
Country
United States
Facility Name
Penn State Cancer Institute at Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Abramson Cancer Center at the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2497
Country
United States
Facility Name
Hillman Cancer Center at University of Pittsburgh Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-0001
Country
United States
Facility Name
CCOP - Marshfield Clinic Research Foundation
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
12. IPD Sharing Statement
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Alemtuzumab Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia
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