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Combination Chemotherapy Plus Filgrastim With or Without Rituximab in Treating Older Patients With Non-Hodgkin's Lymphoma Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Combination Chemotherapy Plus Filgrastim With or Without Rituximab in Treating Older Patients With Non-Hodgkin's Lymphoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Combination Chemotherapy Plus Filgrastim With or Without Rituximab in Treating Older Patients With Non-Hodgkin's Lymphoma Clinical research trials and Combination Chemotherapy Plus Filgrastim With or Without Rituximab in Treating Older Patients With Non-Hodgkin's Lymphoma healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Combination Chemotherapy Plus Filgrastim With or Without Rituximab in Treating Older Patients With Non-Hodgkin's Lymphoma. Combination Chemotherapy Plus Filgrastim With or Without Rituximab in Treating Older Patients With Non-Hodgkin's Lymphoma Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy Plus Filgrastim With or Without Rituximab in Treating Older Patients With Non-Hodgkin's Lymphoma clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Combination Chemotherapy Plus Filgrastim With or Without Rituximab in Treating Older Patients With Non-Hodgkin's Lymphoma condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Filgrastim With or Without Rituximab in Treating Older Patients With Non-Hodgkin's Lymphoma  Combination Chemotherapy Plus Filgrastim With or Without Rituximab in Treating Older Patients With Non-Hodgkin's Lymphoma
Combination Chemotherapy Plus Filgrastim With or Without Rituximab in Treating Older Patients With Non-Hodgkin's Lymphoma
For Condition: adult low grade non-Hodgkin's lymphoma,grade 3 follicular lymphoma,adult non-Hodgkin's lymphoma,adult diffuse large cell lymphoma
Status: Recruiting
Sponsor(s): Commissie Voor Klinisch Toegepast Onderzoek ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells. It is not yet known if combination chemotherapy plus filgrastim is more effective with or without rituximab in treating non-Hodgkin's lymphoma. PURPOSE: Randomizedphase III trial to determine the effectiveness of combination chemotherapy plus filgrastim with or without rituximab in treating older patients who have non-Hodgkin's lymphoma.
Details: OBJECTIVES: - Compare the efficacy of cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP), and filgrastim (G-CSF) with or without rituximab on event-free survival of elderly patients with intermediate or high-risk non-Hodgkin's lymphoma. - Compare the complete remission rate, overall survival, and disease-free survival of patients treated with these regimens. - Compare the toxicity of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, WHO classification, and International Prognostic Index score. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1; oral prednisone on days 1-5; and filgrastim (G-CSF) subcutaneously on days 1-14. Treatment repeats every 2 weeks for 8 courses in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive cyclophosphamide, doxorubicin, vincristine, prednisone, and G-CSF as in arm I. Patients also receive rituximab IV on day 3 of courses 1-2 and on day 1 of courses 3-6 for a total of 6 doses. Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this study within 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 65 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed non-Hodgkin's lymphoma (NHL) - Low- or high-intermediate or high-risk lymphoma of any of the following subtypes: - Mantle cell lymphoma - Follicular lymphoma (grade III) - Diffuse large B-cell lymphoma - CD20-positive - No suspected or documented CNS involvement by NHL 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: - 65 and over Performance status: - WHO 0-2 Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Bilirubin less than 1.75 mg/dL* - Transaminases less than 2.5 times normal* NOTE: * Unless due to NHL Renal: - Creatinine less than 1.7 mg/dL (unless due to NHL) Cardiovascular: - No severe cardiac dysfunction - No New York Heart Association class II-IV heart disease - LVEF at least 45% Pulmonary: - No uncontrolled asthma requiring steroid treatment Other: - HIV negative - No intolerance to exogenous protein administration - No active, uncontrolled infection - No uncontrolled allergy requiring steroid treatment - No other malignancy within the past 5 years except basal cell skin cancer or stage 0 cervical cancer PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior immunotherapy for NHL Chemotherapy: - No prior chemotherapy for NHL Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy for NHL except local radiotherapy for potential organ dysfunction by localized lymphoma mass or infiltration - Concurrent local radiotherapy for potential or actual organ dysfunction by localized lymphoma mass or infiltration allowed Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PieterSonneveld, Study Chair, Daniel Den Hoed Cancer Center at Erasmus Medical Center
Academisch Ziekenhuis Utrecht *Recruiting*
Utrecht, , 3584 CX
Netherlands
Recruiting L. Verdonck 31302507230
Vrije Universiteit Medisch Centrum *Recruiting*
Amsterdam, , 1081HV
Netherlands
Recruiting P.C. Huijgens 31-20-444-2604
Leyenburg Ziekenhuis *Recruiting*
's-Gravenhage, , 2545 CH
Netherlands
Recruiting P.W. Wijermans 31-070-3592556
Academisch Medisch Centrum *Recruiting*
Amsterdam, , 1105 AZ
Netherlands
Recruiting M.H.J. Oers 31-20-566-5785
Academisch Ziekenhuis Groningen *Recruiting*
Groningen, , 9713 EZ
Netherlands
Recruiting G.W. Imhoff 31-50-361-2354
Isala Klinieken - locatie Sophia *Recruiting*
Zwolle, , 8000 GK
Netherlands
Recruiting Marinus Marwijk Kooij 31-38-424-7039
Daniel Den Hoed Cancer Center at Erasmus Medical Center *Recruiting*
Rotterdam, , 3008 AE
Netherlands
Recruiting Mars Van't Veer 31-10-439-1911
Sint Antonius Ziekenhuis *Recruiting*
Nieuwegein, , 3435 CM
Netherlands
Recruiting D.H. Biesma 31-30-609-2088
Meander Medisch Centrum *Recruiting*
Amersfoort, , 3816 CP
Netherlands
Recruiting M.H.H. Kramer 31-33-422-5511
Leiden University Medical Center *Recruiting*
Leiden, , 2300 CA
Netherlands
Recruiting Roel Willemze 31-71-526-2267
Medisch Spectrum Twente *Recruiting*
ENSCHEDE, , 7500 KA
Netherlands
Recruiting M.R. Schaafsma 31-53-487-2444
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital *Recruiting*
Amsterdam, , 1066 CX
Netherlands
Recruiting J. Baars 31-20-512-2570 or 512-2568
Academisch Ziekenhuis Maastricht *Recruiting*
Maastricht, , 6202 AZ
Netherlands
Recruiting Harry Schouten 31-43-387-7025
Additional Information:
Study ID Numbers: CDR0000069122; EU-20130,HOVON-46NHL,HOVON-CKVO-2000-10,CKVO-2000-10
Study Start Date:
Record last reviewed: January 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00028717
Other Grade 3 Follicular Lymphoma Studies:
1. Combination Chemotherapy With or Without Rituximab in Treating Patients With Relapsed Non-Hodgkin's Lymphoma
2. Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone With or Without Gemcitabine in Treating Patients With Previously Untreated Aggressive Non-Hodgkin’s Lymphoma
3. Vaccine Therapy and Sargramostim After Rituximab in Treating Patients With Refractory or Progressive Non-Hodgkin's Lymphoma
4. Combination Chemotherapy in Treating Patients With Aggressive Non-Hodgkin's Lymphoma
5. Combination Chemotherapy With Monoclonal Antibody Therapy in Treating Patients With Newly Diagnosed Non-Hodgkin's Lymphoma
Related Studies:
Other grade 3 follicular lymphoma Clinical Trials
Other Clinical Trials
Other Utrecht Clinical Trials
Combination Chemotherapy Plus Filgrastim With or Without Rituximab in Treating Older Patients With Non-Hodgkin's Lymphoma
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