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Chemotherapy Followed by Radiation Therapy and Peripheral Stem Cell Transplantation Compared With Chemotherapy Plus Interferon Alfa in Treating Patients With Stage III or Stage IV Mantle Cell Lymphoma Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Chemotherapy Followed by Radiation Therapy and Peripheral Stem Cell Transplantation Compared With Chemotherapy Plus Interferon Alfa in Treating Patients With Stage III or Stage IV Mantle Cell Lymphoma conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Chemotherapy Followed by Radiation Therapy and Peripheral Stem Cell Transplantation Compared With Chemotherapy Plus Interferon Alfa in Treating Patients With Stage III or Stage IV Mantle Cell Lymphoma Clinical research trials and Chemotherapy Followed by Radiation Therapy and Peripheral Stem Cell Transplantation Compared With Chemotherapy Plus Interferon Alfa in Treating Patients With Stage III or Stage IV Mantle Cell Lymphoma health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Chemotherapy Followed by Radiation Therapy and Peripheral Stem Cell Transplantation Compared With Chemotherapy Plus Interferon Alfa in Treating Patients With Stage III or Stage IV Mantle Cell Lymphoma. Chemotherapy Followed by Radiation Therapy and Peripheral Stem Cell Transplantation Compared With Chemotherapy Plus Interferon Alfa in Treating Patients With Stage III or Stage IV Mantle Cell Lymphoma Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Chemotherapy Followed by Radiation Therapy and Peripheral Stem Cell Transplantation Compared With Chemotherapy Plus Interferon Alfa in Treating Patients With Stage III or Stage IV Mantle Cell Lymphoma clinical trial. Participants oftentimes recieve the most expert healthcare available for their Chemotherapy Followed by Radiation Therapy and Peripheral Stem Cell Transplantation Compared With Chemotherapy Plus Interferon Alfa in Treating Patients With Stage III or Stage IV Mantle Cell Lymphoma condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Chemotherapy Followed by Radiation Therapy and Peripheral Stem Cell Transplantation Compared With Chemotherapy Plus Interferon Alfa in Treating Patients With Stage III or Stage IV Mantle Cell Lymphoma  Chemotherapy Followed by Radiation Therapy and Peripheral Stem Cell Transplantation Compared With Chemotherapy Plus Interferon Alfa in Treating Patients With Stage III or Stage IV Mantle Cell Lymphoma
Chemotherapy Followed by Radiation Therapy and Peripheral Stem Cell Transplantation Compared With Chemotherapy Plus Interferon Alfa in Treating Patients With Stage III or Stage IV Mantle Cell Lymphoma
For Condition: stage 4 mantle cell lymphoma,stage 3 mantle cell lymphoma
Status: Recruiting
Sponsor(s): German Low Grade Lymphoma Study Group , EORTC Lymphoma Cooperative Group,Gruppo Italiano Studio Linfomi,Groupe d'Etudes de Lymphomes de L'Adulte
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Interferon alfa may interfere with the growth of cancer cells. It is not yet known whether chemotherapy combined with radiation therapy and peripheral stem cell transplantation is more effective than chemotherapy followed by interferon alfa in treating mantle cell lymphoma. PURPOSE: Randomizedphase III trial to compare the effectiveness of chemotherapy followed by radiation therapy, chemotherapy, and peripheral stem cell transplantation with that of chemotherapy plus interferon alfa in treating patients who have stage III or stage IV mantle cell lymphoma.
Details: OBJECTIVES: - Compare the disease-free survival of patients with previously untreated advanced mantle cell lymphoma treated with intensified chemotherapy followed by myeloablative radiochemotherapy and peripheral blood stem cell transplantation (PBSCT) vs standard therapy and interferon alfa maintenance. - Compare the overall survival of patients treated with early vs late myeloablative radiochemotherapy and PBSCT. - Compare disease-free survival and overall survival of patients treated with this regimen vs historic controls of similar cases. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to risk factors (ECOG performance status greater than 1, LDH serum level above normal, and/or extranodal lymphoma involvement) and participating center. Patients are randomized to 1 of 2 treatment arms. - Induction: All patients receive 4 courses of cytoreductive chemotherapy comprising an anthracycline-containing combination. Patients not achieving complete remission after 4 courses receive 2 additional courses of induction chemotherapy. Patients without at least a partial response after 6 courses discontinue treatment; those with at least a partial response proceed to arm I or II. Arm I - Consolidation: Patients achieving complete or partial remission after 4-6 courses of induction therapy begin intensified chemotherapy within 6 weeks. Patients receive oral dexamethasone daily on days 1-10, carmustine IV on day 2, melphalan IV on day 3, etoposide IV daily and cytarabine IV twice a day on days 4-7. Patients also receive filgrastim (G-CSF) beginning on day 11 and continuing until peripheral blood stem cells (PBSC) are harvested. - Within 4-6 weeks after PBSC harvest, patients undergo myeloablative radiochemotherapy comprising radiotherapy on days -6 to -4 and cyclophosphamide IV on days -3 to -2. Patients then undergo PBSC transplantation on day 0. Arm II - Consolidation: Patients receive 2 additional courses of induction chemotherapy as consolidation (for a total of 8 chemotherapy courses). - Maintenance: Within 4 weeks after arm II consolidation, patients receive interferon alfa subcutaneously (SC) 3 days a week in the absence of unacceptable toxicity or disease progression or relapse. Patients who experience first relapse or progression during maintenance therapy may receive intensified chemotherapy as in arm I. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 210 patients will be accrued for this study within 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed stage III or IV mantle cell lymphoma - Previously untreated - Not qualified for primary potentially curative radiotherapy PATIENT CHARACTERISTICS: Age: - 18 to 65 years Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - No impairment of liver function (unless due to lymphoma) - Transaminases no greater than 3 times normal - Bilirubin no greater than 2.0 mg/dL Renal: - No renal insufficiency - Creatinine no greater than 2.0 mg/dL Cardiovascular: - No manifest heart failure or coronary heart disease - No severe uncontrolled hypertension Pulmonary: - No chronic lung disease with hypoxemia Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No severe uncontrolled diabetes mellitus PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior interferon - No prior organ, bone marrow, or peripheral blood stem cell transplantation Chemotherapy: - No prior cytostatic chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
J.C.Kluin-Nelemans, Study Chair, Academisch Ziekenhuis Groningen
A.Z. St. Jan *Recruiting*
Brugge, , 8000
Belgium
Recruiting Achiel Hoof 32- 50- 45-23-10
Ospedale Civile Alessandria *Recruiting*
Alessandria, , I-15100
Italy
Recruiting Alessandro Levis 39-131-206-262
Additional Information:
Study ID Numbers: CDR0000068609; GER-LGLSG-INTERGROUP-20995,EORTC-20995,GELA-INTERGROUP-20995,GISL-INTERGROUP-20995
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00016887
Other Stage 3 Mantle Cell Lymphoma Studies:
1. Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma
2. Rituximab and Cladribine in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma
3. Combination Chemotherapy, Bone Marrow or Peripheral Stem Cell Transplantation, and/or Biological Therapy in Treating Patients With Stage III or Stage IV Mantle Cell Lymphoma
4. Bortezomib in Treating Patients With Mantle Cell Lymphoma
5. Chemotherapy and Rituximab With Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma
Related Studies:
Other stage 3 mantle cell lymphoma Clinical Trials
Other Clinical Trials
Other Alessandria Clinical Trials
Chemotherapy Followed by Radiation Therapy and Peripheral Stem Cell Transplantation Compared With Chemotherapy Plus Interferon Alfa in Treating Patients With Stage III or Stage IV Mantle Cell Lymphoma
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