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Stem Cell Transplantation With or Without Rituximab in Treating Patients With Relapsed or Progressive Large Cell Lymphoma Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Stem Cell Transplantation With or Without Rituximab in Treating Patients With Relapsed or Progressive Large Cell Lymphoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Stem Cell Transplantation With or Without Rituximab in Treating Patients With Relapsed or Progressive Large Cell Lymphoma Clinical research trials and Stem Cell Transplantation With or Without Rituximab in Treating Patients With Relapsed or Progressive Large Cell Lymphoma health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Stem Cell Transplantation With or Without Rituximab in Treating Patients With Relapsed or Progressive Large Cell Lymphoma. Stem Cell Transplantation With or Without Rituximab in Treating Patients With Relapsed or Progressive Large Cell Lymphoma Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Stem Cell Transplantation With or Without Rituximab in Treating Patients With Relapsed or Progressive Large Cell Lymphoma clinical trial. Test subjects typically receive the most expert healthcare available for their Stem Cell Transplantation With or Without Rituximab in Treating Patients With Relapsed or Progressive Large Cell Lymphoma condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Stem Cell Transplantation With or Without Rituximab in Treating Patients With Relapsed or Progressive Large Cell Lymphoma  Stem Cell Transplantation With or Without Rituximab in Treating Patients With Relapsed or Progressive Large Cell Lymphoma
Stem Cell Transplantation With or Without Rituximab in Treating Patients With Relapsed or Progressive Large Cell Lymphoma
For Condition: recurrent adult diffuse large cell lymphoma
Status: Recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI),Cancer and Leukemia Group B
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known if stem cell transplantation is more effective with or without rituximab in treating relapsed or progressiveB-cell diffuse large cell lymphoma. PURPOSE: Randomizedphase III trial to compare the effectiveness of stem cell transplantation with or without rituximab in treating patients who have relapsed or progressive B-cell diffuse large cell lymphoma.
Details: OBJECTIVES: - Compare disease-free survival in patients with relapsed or progressive diffuse large cell lymphoma undergoing stem cell transplantation with or without rituximab. - Evaluate the effect of rituximab pre-transplant and post-transplant on the procedure-related mortality of these patients. - Determine the potential infectious complications of the addition of this drug to autologous stem cell transplantation in these patients. - Compare overall survival of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to relapse (relapsed more than 6 months after either initial complete remission [CR] or CR with positive positron emission tomography or MRI [Gallium] vs failed to achieve initial CR or relapsed within 6 months after either initial CR or CR with positive PET or MRI [Gallium]) and prior rituximab (yes vs no). Patients are randomized to one of two treatment arms. Stem cell mobilization - Arm I: Patients receive rituximab IV over 4-8 hours on days 1, 5, 8, and 13. Patients also receive cyclophosphamide IV over 2 hours on day 9 and filgrastim (G-CSF) subcutaneously (SC) beginning on day 10 and continuing until the last day of apheresis. Stem cells are collected over 1-3 days. Patients also receive rituximab IV over 4-8 hours on days 45 and 52 post-transplant. - Arm II: Patients receive cyclophosphamide IV over 2 hours on day 1 and G-CSF SC beginning on day 2 and continuing until the last day of apheresis. Stem cells are collected over 1-3 days. Preparative regimen - Regimen A (patients who have received prior radiotherapy): Patients receive carmustine IV over 2 hours on day -6, etoposide IV over 4 hours on day -4, and cyclophosphamide IV over 2 hours on day -2. - Regimen B (all other patients): Patients undergo total body irradiation twice daily on days -8 to -5. Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2. Stem cells are reinfused on day 0. Patients receive G-CSF SC beginning on day 6 and continuing until blood counts recover. Patients are followed for 10 years. PROJECTED ACCRUAL: A total of 427 patients will be accrued for this study within 3.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of diffuse large cell lymphoma and meeting the following criteria: - B-cell type with expression of CD20 either at diagnosis or at relapse - Relapse after having achieved an initial complete remission (CR) or failure to achieve initial CR (residual radiographic abnormalities after primary therapy allowed if these abnormalities are also positive by positron emission tomography or MRI [Gallium]) - No newly diagnosed disease - No progressive or stable disease to most recent salvage therapy PATIENT CHARACTERISTICS: Age - 18 to 70 Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 2.0 mg/dL - AST or ALT less than 3 times upper limit of normal Renal - Creatinine no greater than 2.0 mg/dL OR - Creatinine clearance at least 40 mL/min Cardiovascular - Cardiac ejection fraction at least 40% Pulmonary - DLCO at least 60% predicted Other - No other malignancy within the past 2 years except basal cell skin cancer or carcinoma in situ of the cervix - No active infection requiring oral or IV antibiotics - HIV negative - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - See Chemotherapy - No more than 3 prior immunotherapy regimens - At least 3 months since prior rituximab therapy (patients must have responded to the rituximab or the treatments including rituximab) Chemotherapy - No more than 3 prior chemotherapy regimens - Addition of radiation or a monoclonal antibody to chemotherapy is considered one treatment regimen if the addition was part of the initial treatment plan - Addition of these therapies due to lack of response or poor response would be considered an additional treatment regimen whether given in front-line or salvage setting Endocrine therapy - Not specified Radiotherapy - See Chemotherapy - No more than 3 prior radiotherapy regimens - No prior radioimmunotherapy Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
IanFlinn, Study Chair, Sidney Kimmel Cancer Center
Albert Einstein Clinical Cancer Center *Recruiting*
Bronx, New York, 10461
United States
Recruiting Joseph Sparano 718-904-2555
Rocky Mountain Cancer Centers - Rose *Recruiting*
Denver, Colorado, 80220
United States
Recruiting Scot Sedlacek 303-321-0302
CCOP - Evanston *Recruiting*
Evanston, Illinois, 60201
United States
Recruiting Gershon Locker 847-570-2518
CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls, South Dakota, 57104
United States
Recruiting Loren Tschetter 605-328-8044
Penrose Cancer Center *Recruiting*
Colorado Springs, Colorado, 80933
United States
Recruiting Robert Sayre 719-577-2555
MBCCOP - LSU Health Sciences Center *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Jill Gilbert 504-568-5136
Tufts - New England Medical Center *Recruiting*
Boston, Massachusetts, 02111
United States
Recruiting John Erban 617-636-5147
Veterans Affairs Medical Center - Lakeside Chicago *Recruiting*
Chicago, Illinois, 60611-4494
United States
Recruiting Timothy Kuzel 312-469-3748
Rocky Mountain Cancer Centers *Recruiting*
Thornton, Colorado, 80260
United States
Recruiting Alvin Otsuka 303-386-7622
Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Al Benson 312-695-1382
Porter Adventist Hospital *Recruiting*
Denver, Colorado, 80210
United States
Recruiting David Trevarthen 303-788-8675
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231
United States
Recruiting Ian Flinn 410-614-5542
CCOP - Colorado Cancer Research Program, Incorporated *Recruiting*
Denver, Colorado, 80224
United States
Recruiting Eduardo Pajon 303-777-2663
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-3300
United States
Recruiting Carla Falkson 205-975-2691
Stanford Cancer Center at Stanford University Medical Center *Recruiting*
Stanford, California, 94305-5216
United States
Recruiting Harlan Pinto 650-725-9057
Longmont United Hospital *Recruiting*
Longmont, Colorado, 80501
United States
Recruiting Robert Fisher 303-485-4132
Boulder Community Hospital *Recruiting*
Boulder, Colorado, 80301-9019
United States
Recruiting John Fleagle 303-440-2399
Presbyterian-St Luke's Medical Center *Recruiting*
Denver, Colorado, 80218
United States
Recruiting Robert Jotte 303-388-4876
St. Mary-Corwin Regional Medical Center *Recruiting*
Pueblo, Colorado, 81004
United States
Recruiting Marlow Sloan 719-560-6000
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Thomas Habermann 507-284-2511
Swedish Medical Center *Recruiting*
Englewood, Colorado, 80110
United States
Recruiting Marshall Davis 303-788-5860
Medical Center of Aurora - South Campus *Recruiting*
Aurora, Colorado, 80012-0000
United States
Recruiting Sami Diab 303-418-7600
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
Sky Ridge Medical Center *Recruiting*
Lone Tree, Colorado, 80124
United States
Recruiting Dennis Carter 720-225-4211
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792-0001
United States
Recruiting James Stewart 608-265-8131
St. Joseph Hospital *Recruiting*
Denver, Colorado, 80218-1191
United States
Recruiting Michael McLaughlin 303-861-3302
Additional Information:
Study ID Numbers: CDR0000258802; ECOG-E2499,CALGB-E2499,CALGB-50205
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00052923
Other Recurrent Adult Diffuse Large Cell Lymphoma Studies:
1. Arsenic Trioxide in Treating Patients With Relapsed or Refractory Non- Hodgkin's Lymphoma
2. Combination Chemotherapy in Treating Patients With Relapsed or Refractory Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma
3. Interferon alfa-2b Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Hodgkin's Disease or Non- Hodgkin's Lymphoma
4. FR901228 in Treating Patients With Relapsed or Refractory Non-Hodgkin’s Lymphoma
5. Bevacizumab in Treating Patients With Non-Hodgkin's Lymphoma
Related Studies:
Other recurrent adult diffuse large cell lymphoma Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
Stem Cell Transplantation With or Without Rituximab in Treating Patients With Relapsed or Progressive Large Cell Lymphoma
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