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Chemotherapy and Peripheral Stem Cell Transplantation With or Without Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Chemotherapy and Peripheral Stem Cell Transplantation With or Without Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Chemotherapy and Peripheral Stem Cell Transplantation With or Without Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma Clinical research trials and Chemotherapy and Peripheral Stem Cell Transplantation With or Without Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma health trials occur in a lot of 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 potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Chemotherapy and Peripheral Stem Cell Transplantation With or Without Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma. Chemotherapy and Peripheral Stem Cell Transplantation With or Without Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Chemotherapy and Peripheral Stem Cell Transplantation With or Without Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma clinical trial. Human subjects often get the best healthcare possible for their Chemotherapy and Peripheral Stem Cell Transplantation With or Without Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Chemotherapy and Peripheral Stem Cell Transplantation With or Without Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma  Chemotherapy and Peripheral Stem Cell Transplantation With or Without Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma
Chemotherapy and Peripheral Stem Cell Transplantation With or Without Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma
For Condition: recurrent grade 3 follicular lymphoma,recurrent 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 tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by the chemotherapy. Monoclonal antibodies 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 combination chemotherapy plus peripheral stem cell transplantation is more effective with or without monoclonal antibody therapy in treating non-Hodgkin's lymphoma. PURPOSE: Randomizedphase III trial to compare the effectiveness of combination chemotherapy plus peripheral stem cell transplantation with or without monoclonal antibody therapy in treating patients who have relapsed non-Hodgkin's lymphoma.
Details: OBJECTIVES: - Compare the partial and complete response rates in patients with relapsed, CD20 positive, aggressive B-cell non-Hodgkin's lymphoma treated with dexamethasone, cisplatin, and cytarabine in combination with etoposide, ifosfamide, and methotrexate with or without rituximab followed by carmustine, etoposide, cytarabine, melphalan, and autologous peripheral blood stem cell transplantation (APBSCT). - Compare the effect of APBSCT with or without rituximab on the overall and event-free survival of these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to one of two treatment arms. - Arm I: Patients receive DHAP induction chemotherapy comprising dexamethasone orally or IV on days 1-4, cisplatin IV continuously over 24 hours on day 1, and cytarabine IV over 3 hours every 12 hours on day 2. Beginning 3-4 weeks after DHAP, patients receive VIM induction chemotherapy comprising etoposide IV over 2 hours on days 1, 3, and 5; ifosfamide IV over 1 hour on days 1-5; and methotrexate IV on days 1 and 5. Beginning 3-4 weeks after VIM, patients with partial or complete response after DHAP and VIM receive a second course of DHAP (patients with progressive or unresponsive disease after DHAP but responsive disease after VIM receive a second course of VIM) followed by filgrastim (G-CSF) subcutaneously beginning on day 10 and continuing until a target number of cells are collected. - Arm II: Patients receive induction chemotherapy and G-CSF as in arm I. At 1 day after the last dose of each chemotherapy course, patients also receive rituximab IV once for a maximum of 3 courses. At 4-5 weeks after the completion of the last induction chemotherapy course, responsive patients in both arms receive BEAM conditioning chemotherapy comprising carmustine IV over 60 minutes on day -6, etoposide IV over 60 minutes and cytarabine IV over 30 minutes on days -5 to -2, and melphalan IV over 15 minutes on day -1. Patients undergo autologous peripheral blood stem cell transplantation on day 0. After transplantation, patients in partial remission may undergo radiotherapy to nodal sites with residual tumor mass. Patients are followed every 6 months for 3 years and then annually thereafter. PROJECTED ACCRUAL: A total of 296-340 patients (148-170 per treatment arm) will be accrued for this study within 4-5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed relapsed B-cell non-Hodgkin's lymphoma (NHL) - Diffuse large cell B-cell lymphoma - Grade III follicular center-cell lymphoma - Primary mediastinal B-cell lymphoma - CD20 positive - First relapse after doxorubicin containing regimen - Documented remission of at least 3 months after first-line chemotherapy - No Epstein-Barr virus post-transplantation lymphoproliferative disorder - No CNS involvement PATIENT CHARACTERISTICS: Age: - 18 to 65 Performance status: - WHO 0-1 Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - No hepatic dysfunction - Bilirubin less than 2.5 times upper limit of normal (ULN) - Transaminases less than 2.5 times ULN Renal: - No renal dysfunction - Creatinine less than 2.0 mg/dL OR - Creatinine clearance greater than 40 mL/min Cardiovascular: - No severe cardiac dysfunction - No New York Heart association class II-IV heart disease Pulmonary: - No severe pulmonary dysfunction - Vital capacity or diffusion capacity at least 70% predicted unless related to NHL involvement Other: - No active uncontrolled infection - HIV negative - No intolerance to exogenous protein administration PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 1 month since prior immunotherapy Chemotherapy: - See Disease Characteristics - At least 1 month since prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - At least 1 month since prior radiotherapy Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EdoVellenga, Study Chair, Academisch Ziekenhuis Groningen
Daniel Den Hoed Cancer Center at Erasmus Medical Center *Recruiting*
Rotterdam, , 3008 AE
Netherlands
Recruiting Pieter Sonneveld 31-10-439-1911
Sint Antonius Ziekenhuis *Recruiting*
Nieuwegein, , 3435 CM
Netherlands
Recruiting D.H. Biesma 31-30-609-2088
Isala Klinieken - locatie Sophia *Recruiting*
Zwolle, , 8000 GK
Netherlands
Recruiting Marinus Marwijk Kooij 31-38-424-7039
Leiden University Medical Center *Recruiting*
Leiden, , 2300 CA
Netherlands
Recruiting Willem Fibbe 31-71-526-2261
Vrije Universiteit Medisch Centrum *Recruiting*
Amsterdam, , 1081HV
Netherlands
Recruiting P.C. Huijgens 31-20-444-2604
Academisch Ziekenhuis Groningen *Recruiting*
Groningen, , 9713 EZ
Netherlands
Recruiting G.W. Imhoff 31-50-361-2354
Academisch Ziekenhuis Utrecht *Recruiting*
Utrecht, , 3584 CX
Netherlands
Recruiting Anton Hagenbeek 31-30-250-7769
Medisch Centrum Leeuwarden - Zuid *Recruiting*
Leeuwarden, , 8934 AD
Netherlands
Recruiting P. Joosten 31-58-286-6965
Meander Medisch Centrum *Recruiting*
Amersfoort, , 3816 CP
Netherlands
Recruiting M.H.H. Kramer 31-33-422-5511
Leyenburg Ziekenhuis *Recruiting*
's-Gravenhage, , 2545 CH
Netherlands
Recruiting P.W. Wijermans 31-070-3592556
U.Z. Gasthuisberg *Recruiting*
Leuven, , B-3000
Belgium
Recruiting G.E.G. Verhoef 32-16-34608
Academisch Medisch Centrum *Recruiting*
Amsterdam, , 1105 AZ
Netherlands
Recruiting M.H.J. Oers 31-20-566-5785
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital *Recruiting*
Amsterdam, , 1066 CX
Netherlands
Recruiting J. Baars 31-20-512-2570 or 512-2568
University Medical Center Nijmegen *Recruiting*
Nijmegen, , NL-6500 HB
Netherlands
Recruiting John Raemaekers 31-24-361-4762
Groot Ziekengasthuis 's-Hertogenbosch *Recruiting*
's-Hertogenbosch, , 5211 NL
Netherlands
Recruiting H.A.M. Sinnige 31 73 6162452
Santa Rosa Radiation Oncology Center *Recruiting*
Maastricht, , 6202 AZ
Netherlands
Recruiting Harry Schouten 31-43-387-7025
Medisch Spectrum Twente *Recruiting*
ENSCHEDE, , 7500 KA
Netherlands
Recruiting M.R. Schaafsma 31-53-487-2444
Additional Information:
Study ID Numbers: CDR0000068476; EU-20042,HOVON-44/CKVO-2000-06,CKVO-2000-06,HOVON-44
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00012051
Other Recurrent Grade 3 Follicular Lymphoma Studies:
1. Rituximab and Interleukin-2 in Treating Patients With Low-Grade or Follicular Non-Hodgkin's Lymphoma That is Refractory to Rituximab
2. Vaccine Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma
3. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation With or Without Rituximab in Treating Patients With Relapsed Non-Hodgkin's Lymphoma
4. Biological Therapy Following Chemotherapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
5. Monoclonal Antibodies in Treating Patients with Relapsed or Refractory Follicular Non-Hodgkin's Lymphoma
Related Studies:
Other recurrent grade 3 follicular lymphoma Clinical Trials
Other Clinical Trials
Other Nijmegen Clinical Trials
Chemotherapy and Peripheral Stem Cell Transplantation With or Without Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma
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