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| Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006252 |
Purpose
RATIONALE: Giving chemotherapy drugs, such as fludarabine and cyclophosphamide, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
PURPOSE: This phase II trial is studying how well fludarabine and cyclophosphamide followed by peripheral stem cell transplant works in treating patients with leukemia or lymphoma.
| Condition | Intervention | Phase |
|
Leukemia Lymphoma |
Drug: cyclophosphamide Drug: filgrastim Drug: fludarabine phosphate Drug: therapeutic allogeneic lymphocytes Procedure: peripheral blood stem cell transplantation |
Phase II |
| MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma |
| ChemIDplus related topics: | Cyclophosphamide Filgrastim Fludarabine Fludarabine monophosphate |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Minimal Ablation and Cellular Immune Therapy of Chronic Lymphocytic Leukemia, Prolymphocytic Leukemia, Low-Grade Non-Hodgkin's Lymphoma, and Mantle Cell Lymphoma With Allogeneic Donor Stem Cells |
| Estimated Enrollment: | 45 |
| Study Start Date: | February 2001 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive fludarabine IV over 30 minutes on days -7 to -3 and cyclophosphamide IV over 1 to 2 hours on days -5 to -3. Patients undergo allogeneic peripheral blood stem cell transplantation on days 0-1. Patients then receive filgrastim (G-CSF) subcutaneously daily beginning on day 5 and continuing until blood counts recover.
Patients with no signs of active graft-versus host disease and stable or progressive disease receive donor lymphocytes IV over 2 hours beginning after day 120. Patients may receive a total of 3 infusions at least 8 weeks apart if disease remains stable or progressive.
Patients are followed every 3 months for 2 years and then every 6 months for 5 years.
PROJECTED ACCRUAL: A maximum of 45 patients will be accrued for this study.
Eligibility
| Ages Eligible for Study: | up to 69 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
One of the following histologically confirmed diagnoses:
Chronic lymphocytic leukemia
Failed at least 1 prior regimen
= 17p deletion = 11q deletion
p53 mutations
Prolymphocytic leukemia (PLL)
Low-grade non-Hodgkin's lymphoma
Disease stage III or IV
Mantle cell lymphoma
Rearrangement of BCL1 gene
Responsive or stable disease to most recent prior therapy
Must have HLA identical sibling (6/6) donor by serologic typing (A, B, DR)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, California | |||||
| Rebecca and John Moores UCSD Cancer Center | |||||
| La Jolla, California, United States, 92093-0658 | |||||
| UCSF Comprehensive Cancer Center | |||||
| San Francisco, California, United States, 94115 | |||||
| Veterans Affairs Medical Center - San Diego | |||||
| San Diego, California, United States, 92161 | |||||
| United States, Delaware | |||||
| Beebe Medical Center | |||||
| Lewes, Delaware, United States, 19958 | |||||
| CCOP - Christiana Care Health Services | |||||
| Newark, Delaware, United States, 19713 | |||||
| St. Francis Hospital | |||||
| Wilmington, Delaware, United States, 19805 | |||||
| United States, Iowa | |||||
| Holden Comprehensive Cancer Center at University of Iowa | |||||
| Iowa City, Iowa, United States, 52242 | |||||
| United States, Maryland | |||||
| Union Hospital Cancer Center at Union Hospital | |||||
| Elkton MD, Maryland, United States, 21921 | |||||
| United States, Massachusetts | |||||
| UMASS Memorial Cancer Center - University Campus | |||||
| Worcester, Massachusetts, United States, 01655 | |||||
| United States, New Jersey | |||||
| Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees | |||||
| Voorhees, New Jersey, United States, 08043 | |||||
| United States, New York | |||||
| Elmhurst Hospital Center | |||||
| Elmhurst, New York, United States, 11373 | |||||
| Mount Sinai Medical Center | |||||
| New York, New York, United States, 10029 | |||||
| Queens Cancer Center of Queens Hospital | |||||
| Jamaica, New York, United States, 11432 | |||||
| Roswell Park Cancer Institute | |||||
| Buffalo, New York, United States, 14263-0001 | |||||
| United States, North Carolina | |||||
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |||||
| Chapel Hill, North Carolina, United States, 27599-7295 | |||||
| Wake Forest University Comprehensive Cancer Center | |||||
| Winston-Salem, North Carolina, United States, 27157-1096 | |||||
| United States, Ohio | |||||
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | |||||
| Columbus, Ohio, United States, 43210-1240 | |||||
| United States, Pennsylvania | |||||
| Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | |||||
| Pittsburgh, Pennsylvania, United States, 15224-1791 | |||||
| United States, Virginia | |||||
| Massey Cancer Center at Virginia Commonwealth University | |||||
| Richmond, Virginia, United States, 23298-0037 | |||||
| Cancer and Leukemia Group B |
| National Cancer Institute (NCI) |
| Study Chair: | Thomas C. Shea, MD | UNC Lineberger Comprehensive Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Shea TC, Johnston J, Walsh W, et al.: Reduced intensity allogeneic transplantation provides high disease-free and overall survival in patients (pts) with advanced indolent NHL and CLL: CALGB 109901. [Abstract] Blood 110 (11): A-486, 2007. |
| Study ID Numbers: | CDR0000068185, CALGB-109901 |
| First Received: | September 11, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00006252 |
| Health Authority: | United States: Federal Government |
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