|
Fludarabine and Cyclophosphamide Followed by Peripheral Stem Cell Transplantation in Treating Patients With Leukemia or Lymphoma Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Fludarabine and Cyclophosphamide Followed by Peripheral Stem Cell Transplantation in Treating Patients With Leukemia or Lymphoma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Fludarabine and Cyclophosphamide Followed by Peripheral Stem Cell Transplantation in Treating Patients With Leukemia or Lymphoma Clinical research trials and Fludarabine and Cyclophosphamide Followed by Peripheral Stem Cell Transplantation in Treating Patients With Leukemia or Lymphoma medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Fludarabine and Cyclophosphamide Followed by Peripheral Stem Cell Transplantation in Treating Patients With Leukemia or Lymphoma. Fludarabine and Cyclophosphamide Followed by Peripheral Stem Cell Transplantation in Treating Patients With Leukemia or Lymphoma Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Fludarabine and Cyclophosphamide Followed by Peripheral Stem Cell Transplantation in Treating Patients With Leukemia or Lymphoma clinical trial. Subjects typically recieve the finest healthcare available for their Fludarabine and Cyclophosphamide Followed by Peripheral Stem Cell Transplantation in Treating Patients With Leukemia or Lymphoma condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "F" Clinical Trials Conditions > Fludarabine and Cyclophosphamide Followed by Peripheral Stem Cell Transplantation in Treating Patients With Leukemia or Lymphoma  Fludarabine and Cyclophosphamide Followed by Peripheral Stem Cell Transplantation in Treating Patients With Leukemia or Lymphoma
Fludarabine and Cyclophosphamide Followed by Peripheral Stem Cell Transplantation in Treating Patients With Leukemia or Lymphoma
For Condition: Chronic Lymphocytic Leukemia,Prolymphocytic Leukemia,adult non-Hodgkin's lymphoma
Status: Recruiting
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. PURPOSE: Phase II trial to study the effectiveness of fludarabine and cyclophosphamide followed by peripheral stem cell transplantation in treating patients who have leukemia or lymphoma.
Details: OBJECTIVES: - Determine the feasibility of fludarabine and cyclophosphamide followed by allogeneic peripheral blood stem cell transplantation, in terms of 6-month treatment-related mortality, in patients with chronic lymphocytic leukemia, prolymphocytic leukemia, low-grade non-Hodgkin's lymphoma, or mantle cell lymphoma. - Determine the 6-month and 12-month probabilities of response in patients treated with this regimen. - Determine the time to disease progression in patients responding to this regimen. - Determine the percentage of donor chimerism achieved in patients treated with this regimen. - Determine the risk of acute and chronic graft-versus-host disease in patients treated with this regimen. - Determine the toxic effects of this regimen in these patients. - Determine the overall survival and disease-free survival of patients treated with this regimen. 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /69 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - One of the following histologically confirmed diagnoses: - Chronic lymphocytic leukemia - Absolute lymphocytosis greater than 5,000/mm^3 - Morphologically mature lymphocytes with less than 55% prolymphocytes - Lymphocyte phenotypic expression of CD19 and CD5 - Failed at least 1 prior regimen - Progressive lymphocytosis with more than 50% increase in peripheral lymphocytosis or a progressive lymph node or spleen enlargement (at least 25% enlargement or the appearance of new lymph nodes) that persists for at least 4 weeks despite concurrent or prior drug treatment OR - At least 1 of the following high-risk factors and not in first complete remission - 17p deletion - 11q deletion - Unmutated VH gene status - p53 mutations - Prolymphocytic leukemia (PLL) - Absolute lymphocytosis greater than 5,000/mm^3 - Morphologically mature lymphocytes with more than 55% prolymphocytes - Low-grade non-Hodgkin's lymphoma - Small lymphocytic lymphoma - Follicular center lymphoma (grade I or II) - Diffuse (predominately small cell type) - Marginal zone, B-cell lymphoma - No transformed lymphoma - Failure of at least 1 prior regimen OR - At least 3 of the following risk factors: - Over 60 years of age - Performance status greater than 1 - LDH greater than normal - More than 1 site of extranodal disease - Disease stage III or IV - Mantle cell lymphoma - Any stage - Ineligible for protocol CALGB-59908 - At least 1 prior treatment regimen - At least 1 of the following: - Immunophenotypic expression of CD5 and CD19 and absence of CD23 - Cytogenetic analysis with presence of t(11;14) - Overexpression of cyclin D1 - Rearrangement of BCL1 gene - Responsive or stable disease to most recent prior therapy - Prior therapy for PLL not required - Must have HLA identical sibling (6/6) donor by serologic typing (A, B, DR) - No syngeneic donors - No age restriction NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: - Under 70 Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Granulocyte count at least 500/mm^3* - Platelet count at least 50,000/mm^3* NOTE: *Unless attributable to disease Hepatic: - Bilirubin no greater than 3 times upper limit of normal (ULN)* - AST no greater than 3 times ULN* NOTE: *Unless attributable to disease Renal: - Creatinine clearance at least 40 mL/min, unless attributable to disease Cardiovascular: - LVEF at least 30% by MUGA Pulmonary: - DLCO greater than 40% - No symptomatic pulmonary disease Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No uncontrolled diabetes mellitus - No active serious infection - No known hypersensitivity to E. coli-derived products PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior autologous transplantation Chemotherapy: - At least 4 weeks since prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - At least 4 weeks since prior radiotherapy Surgery: - At least 4 weeks since prior surgery
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ThomasShea, Study Chair, UNC Lineberger Comprehensive Cancer Center
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Joseph Antin 617-632-2525
New Hanover Regional Medical Center *Recruiting*
Wilmington, North Carolina, 28402-9025
United States
Recruiting Cyrus Kotwall 910-763-4630
Lenoir Memorial Hospital Cancer Center *Recruiting*
Kinston, North Carolina, 28503-1678
United States
Recruiting Peter Watson 919-559-2200 Ext. 201
Lahey Clinic Medical Center - Burlington *Recruiting*
Burlington, Massachusetts, 01805
United States
Recruiting Arthur Rabinowitz 781-744-8400
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center *Recruiting*
Oklahoma City, Oklahoma, 73104
United States
Recruiting Howard Ozer 405-271-4022
Vermont Cancer Center at University of Vermont *Recruiting*
Burlington, Vermont, 05401-3498
United States
Recruiting Barbara Grant 802-847-8400
Green Cancer Center at Scripps Clinic *Recruiting*
La Jolla, California, 92037-1027
United States
Recruiting James Mason 858-554-8597
University of Minnesota Cancer Center *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting Philip McGlave 612-624-5422
University Hospital at State University of New York - Upstate Medical University *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Teresa Gentile 315-464-8240
Jacobi Medical Center *Recruiting*
Bronx, New York, 10461
United States
Recruiting Adrian Langleben 718-918-5684
West Suburban Center for Cancer Care *Recruiting*
River Forest, Illinois, 60305
United States
Recruiting John Showel 708-763-2700
Oncology and Hematology Associates of Southwest Virginia, Inc. *Recruiting*
Roanoke, Virginia, 24014
United States
Recruiting Paul Richards 540-982-0237
Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina *Recruiting*
Greenville, North Carolina, 27835-6028
United States
Recruiting Terrance Comeau 919-816-2554
Brigham and Women's Hospital *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Joseph Antin 617-732-5500
Veterans Affairs Medical Center - Dallas *Recruiting*
Dallas, Texas, 75216
United States
Recruiting Barry Levinson 214-648-4193
Rebecca and John Moores UCSD Cancer Center *Recruiting*
La Jolla, California, 92093-0690
United States
Recruiting Asad Bashey 858-657-6790
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1082
United States
Recruiting David Hurd 336-716-2088
Cooper University Hospital *Recruiting*
Camden, New Jersey, 08103
United States
Recruiting Edison Catalano 856-342-2506
FirstHealth Moore Regional Hospital *Recruiting*
Pinehurst, North Carolina, 28374
United States
Recruiting Ellen Willard 910-295-9205
Cape Fear Valley Health System *Recruiting*
Fayetteville, North Carolina, 28302-2000
United States
Recruiting Kamal Bakri 910-609-6910
New York Weill Cornell Cancer Center at Cornell University *Recruiting*
New York City, New York, 10021
United States
Recruiting Scott Wadler 212-746-2844
Martha Jefferson Hospital *Recruiting*
Charlottesville, Virginia, 22902
United States
Recruiting Stefan Gorsch 434-982-8410
St. Luke's Medical Center *Recruiting*
Milwaukee, Wisconsin, 53215
United States
Recruiting Robert Taylor 414-384-5111
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting Koen Besien 773-702-6696
Veterans Affairs Medical Center - San Diego *Recruiting*
San Diego, California, 92161
United States
Recruiting Saeeda Kirmani 619-552-8585 ext. 3356
Siteman Cancer Center *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Randy Brown 314-454-8227
Veterans Affairs Medical Center - Las Vegas *Recruiting*
Las Vegas, Nevada, 89106
United States
Recruiting Chitha Hulugalle 702-696-3000
NorthEast Oncology Associates *Recruiting*
Concord, North Carolina, 28025
United States
Recruiting James Wall 704-783-1370
Louis A. Weiss Memorial Hospital *Recruiting*
Chicago, Illinois, 60640
United States
Recruiting Keith Shulman 773-564-5022
CCOP - Kansas City *Recruiting*
Kansas City, Missouri, 64131
United States
Recruiting Jorge Paradelo 816-823-0555
Queens Cancer Center of Queens Hospital *Recruiting*
Jamaica, New York, 11432
United States
Recruiting Hans Grunwald 718-883-4118
Holden Comprehensive Cancer Center at University of Iowa *Recruiting*
Iowa City, Iowa, 52242-1009
United States
Recruiting Roger Gingrich 312-356-3425
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph *Recruiting*
Saint Joseph, Michigan, 49085
United States
Recruiting Eric Lester 269-982-4963
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94115
United States
Recruiting Charles Linker 415-353-9510
Memorial Regional Hospital Comprehensive Cancer Center *Recruiting*
Hollywood, Florida, 33021
United States
Recruiting Atif Hussein 954-986-6363
Palm Beach Cancer Institute *Recruiting*
West Palm Beach, Florida, 33401
United States
Recruiting Robert Jacobson 561-366-4150
Roswell Park Cancer Institute *Recruiting*
Buffalo, New York, 14263-0001
United States
Recruiting Philip McCarthy 716-845-8707
St. Joseph's Hospital and Medical Center *Recruiting*
Paterson, New Jersey, 07503
United States
Recruiting Arnold Rubin 973-754-2432
Virginia Oncology Associates - Norfolk *Recruiting*
Norfolk, Virginia, 23502
United States
Recruiting Paul Conkling 757-466-8683
Norris Cotton Cancer Center at Dartmouth Medical School *Recruiting*
Lebanon, New Hampshire, 03756-0002
United States
Recruiting Marc Ernstoff 603-650-5534
Broward General Medical Center *Recruiting*
Ft. Lauderdale, Florida, 33316
United States
Recruiting Luis Barreras 954-771-0692
Lutheran General Cancer Care Center *Recruiting*
Park Ridge, Illinois, 60068-1270
United States
Recruiting Jacob Bitran 847-268-8200
Florida Hospital Cancer Institute *Recruiting*
Orlando, Florida, 32804
United States
Recruiting Jane Crofton 407-303-2090
Cancer Centers of the Carolinas - Eastside *Recruiting*
Greenville, South Carolina, 29615
United States
Recruiting Gary Spitzer 864-370-1393
Northeast Alabama Regional Medical Center *Recruiting*
Anniston, Alabama, 36207
United States
Recruiting Thomas Twele 256-236-2549
Maine Center for Cancer Medicine and Blood Disorders - Scarborough *Recruiting*
Scarborough, Maine, 04074
United States
Recruiting Thomas Ervin 207-885-7600
Palmetto Richland Memorial Hospital *Recruiting*
Columbia, South Carolina, 29203
United States
Recruiting P. Henslee-Downey 803-434-3550
Veterans Affairs Medical Center - Asheville *Recruiting*
Asheville, North Carolina, 28805
United States
Recruiting John Lucke 828-299-2540
Boone Hospital Center *Recruiting*
Columbia, Missouri, 65201
United States
Recruiting Joseph Muscato 573-815-8000
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Craig Moskowitz 212-639-2696
Veterans Affairs Medical Center - Washington, DC *Recruiting*
Washington D.C., District of Columbia, 20422
United States
Recruiting Steven Krasnow 202-745-8178
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-3300
United States
Recruiting William Vaughan 205-934-0930
Blumenthal Cancer Center at Carolinas Medical Center *Recruiting*
Charlotte, North Carolina, 28232-2861
United States
Recruiting Gary Frenette 704-355-3789
St. Mary's Medical Center *Recruiting*
Huntington, West Virginia, 25701
United States
Recruiting Gerrit Kimmey 304-528-4645
Elmhurst Hospital Center *Recruiting*
Elmhurst, New York, 11373
United States
Recruiting Vladimir Benisovich 718-334-3723
Marlene and Stewart Greenebaum Cancer Center, University of Maryland *Recruiting*
Baltimore, Maryland, 21201
United States
Recruiting Barry Meisenberg 410-328-6842
Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus, Ohio, 43210-1240
United States
Recruiting Edward Copelan 614-293-3121
UNMC Eppley Cancer Center at the University of Nebraska Medical Center *Recruiting*
Omaha, Nebraska, 68198-7680
United States
Recruiting Elizabeth Reed 402-559-5520
Massachusetts General Hospital Cancer Center *Recruiting*
Boston, Massachusetts, 02114-2698
United States
Recruiting Thomas Spitzer 617-724-1124
Baptist Hospital East - Louisville *Recruiting*
Louisville, Kentucky, 40207
United States
Recruiting Daniel Scullin 502-897-1166
North Shore University Hospital *Recruiting*
Manhasset, New York, 11030
United States
Recruiting Aby Buchbinder 516-562-8973
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting James Vredenburgh 919-684-5301
CCOP - Illinois Oncology Research Association *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting John Kugler 309-636-3605
Saint Anthony Medical Center *Recruiting*
Rockford, Illinois, 61108
United States
Recruiting Richard Nora 815-227-2273
University of Massachusetts Memorial Medical Center - University Campus *Recruiting*
Worcester, Massachusetts, 01655
United States
Recruiting Pankaj Bhargava 508-856-6884
Mount Sinai Medical Center, NY *Recruiting*
New York City, New York, 10029
United States
Recruiting Steven Fruchtman 212-241-6021
CCOP - Christiana Care Health Services *Recruiting*
Newark, Delaware, 19713
United States
Recruiting Robert Slease 302-623-4550
New Hampshire Oncology-Hematology, PA - Hooksett *Recruiting*
Hooksett, New Hampshire, 03106
United States
Recruiting Douglas Weckstein 603-622-6484
University of Puerto Rico School of Medicine Medical Sciences Campus *Recruiting*
San Juan, , 00936-5067
Puerto Rico
Recruiting Enrique Velez-Garcia 787-754-0101 Ext.2020
Fort Wayne Medical Oncology and Hematology, Incorporated *Recruiting*
Ft. Wayne, Indiana, 46885-5099
United States
Recruiting Sreenivasa Nattam 219-484-8830
Additional Information:
Study ID Numbers: CDR0000068185; CALGB-109901
Study Start Date:
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006252
Other Prolymphocytic Leukemia Studies:
1. Bortezomib and Fludarabine in Treating Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
2. Phase I Study of Anti-Tac(Fv)-PE38 (LMB-2), a Recombinant Single-Chain Immunotoxin for Treatment of Tac-Expressing Malignancies
3. Phase I/II Study of Genasense in Patients With Chronic Lymphocytic Leukemia
4. Dose-Escalating and Safety Study of CP-461 in Patients with Chronic Lymphocytic Leukemia
5. Phase I Study of BL22, a Recombinant Immunotoxin for Treatment of CD22+ Leukemias and Lymphomas
Related Studies:
Other Prolymphocytic Leukemia Clinical Trials
Other New York Clinical Trials
Other Manhasset Clinical Trials
Fludarabine and Cyclophosphamide Followed by Peripheral Stem Cell Transplantation in Treating Patients With Leukemia or Lymphoma
|
|
|
|
|
|
|
|
