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Radiation Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma Who Have Undergone Stem Cell Transplantation Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Radiation Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma Who Have Undergone Stem Cell Transplantation conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Radiation Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma Who Have Undergone Stem Cell Transplantation Clinical research trials and Radiation Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma Who Have Undergone Stem Cell Transplantation healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Radiation Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma Who Have Undergone Stem Cell Transplantation. Radiation Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma Who Have Undergone Stem Cell Transplantation Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Radiation Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma Who Have Undergone Stem Cell Transplantation clinical trial. Participants typically obtain the most effective healthcare available for their Radiation Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma Who Have Undergone Stem Cell Transplantation condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Radiation Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma Who Have Undergone Stem Cell Transplantation  Radiation Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma Who Have Undergone Stem Cell Transplantation
Radiation Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma Who Have Undergone Stem Cell Transplantation
For Condition: recurrent adult diffuse large cell lymphoma,anaplastic large cell lymphoma,Waldenstrom's Macroglobulinemia,recurrent adult T-cell leukemia/lymphoma,recurrent adult diffuse small noncleaved cell/Burkitt's lymphoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute of Canada ,
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if giving radiation therapy after stem cell transplantation is more effective than stem cell transplantation alone in treating relapsed or refractory non-Hodgkin's lymphoma. PURPOSE: Randomized phase III trial to determine the effectiveness of radiation therapy in treating patients who have relapsed or refractory non-Hodgkin's lymphoma and have undergone autologous stem cell transplantation.
Details: OBJECTIVES: I. Compare the 3-year progression-free survival in patients with relapsed or refractory aggressive non-Hodgkin's lymphoma treated with high-dose chemotherapy and autologous hematopoietic stem cell transplantation with or without involved-field radiotherapy. II. Compare the overall survival in patients treated with these regimens. III. Compare 3-year progression-free disease within and outside radiotherapy fields in patients treated with these regimens. IV. Compare quality of life in patients treated with these regimens. V. Compare the toxic effects of these regimens in these patients . PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to response to pre-salvage chemotherapy (primary refractory disease vs relapse), response to post-salvage chemotherapy (complete/unconfirmed complete vs partial), and participating center. Within 6-8 weeks after completion of autologous hematopoietic stem cell transplantation, patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo involved-field radiotherapy (IFRT) 5 days a week for 3-5 weeks in the absence of unacceptable toxicity. Arm II: Patients undergo observation only. Quality of life in arm I is assessed at baseline, on day 1 of IFRT, at weeks 2 and 4 during IFRT, at 1 month, 4 months, every 3 months for 2 years, every 6 months for 1 year, and then annually for 2 years. Quality of life in arm II is assessed at baseline, 1 month, 2 months, every 3 months for 2 years, every 6 months for 1 year, and then annually for 2 years. Patients are followed at 1 month, every 3 months for 2 years, every 6 months for 1 year, and then annually for 2 years. PROJECTED ACCRUAL: A total of 230 patients (115 per treatment arm) will be accrued for this study within 4.2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically confirmed non-Hodgkin's lymphoma - Diffuse large cell lymphoma, B-cell (includes primary mediastinal B-cell lymphoma and T-cell rich B-cell lymphoma) - Previous indolent lymphoma (follicular center cell lymphoma, marginal zone lymphoma, including extranodal MALT lymphoma and lymphoplasmacytoid lymphoma) with transformation to diffuse large B-cell lymphoma at relapse - Peripheral T-cell lymphoma - Anaplastic large cell lymphoma (T cell or null cell) - Small non-cleaved Burkitt-like lymphoma Relapsed or refractory disease after first-line anthracycline-based chemotherapy - Bulky disease, nodal or extranodal (Clinically or radiographically measurable mass at least 5 cm in diameter) OR - Non-bulky disease, nodal or extranodal, excluding diffuse organ (lung, liver, kidney, or bone marrow) involvement (Clinically or radiographically measurable disease more than 1.5 cm in greatest transverse diameter) Biopsy at relapse not required except for transformed lymphomas - Patients with transformed lymphoma at diagnosis, but with indolent histology without transformation at relapse, are not eligible No patients with stage IA or IIA disease at initial diagnosis who, at time of relapse or diagnosis of refractory disease prior to salvage, remained in stage IA or IIA, with no new disease sites, without having received radiotherapy Received up to 2 regimens and 4 courses of salvage chemotherapy - Monoclonal antibodies (e.g., rituximab) are not considered salvage chemotherapy - Achieved complete response (CR), unconfirmed CR, or partial response (PR) if bulky disease OR - Achieved PR (but not CR) if non-bulky disease No residual disease involving extranodal organs diffusely (e.g., liver, lung, bone, kidney, or leptomeningeal) after salvage chemotherapy Planned autologous hematopoietic stem cell transplantation (ASCT) - ASCT conditioning must be with high-dose BEAM (carmustine, etoposide, cytarabine, and melphalan) chemotherapy No disease progression after ASCT No major organ complication or poor hematologic recovery from ASCT that would preclude initiation of study radiotherapy within 14 weeks after ASCT No more than 2 non-contiguous nodal or extranodal areas of bulky/residual disease requiring more than 2 separate involved-field radiotherapy volume arrangements (e.g., field arrangement covering up to 2 involved lymph node regions or extranodal sites, with or without 1 adjacent nodal/region or extranodal site) No active CNS lymphoma (parenchymal brain and/or leptomeningeal) --Prior/Concurrent Therapy-- Biologic therapy: - See Disease Characteristics - No prior radioimmunotherapy Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: - See Disease Characteristics - No prior total body irradiation - No prior radiotherapy to the site of bulky disease or residual tumor Surgery: Not specified Other: - No other concurrent anti-cancer therapy unless documentation of disease progression --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not specified Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No other malignancy within the past 5 years except basal cell carcinoma of the skin
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RichardTsang, Study Chair, National Cancer Institute of Canada
Newfoundland Cancer Treatment and Research Foundation
St. Johns, Newfoundland and Labrador, A1B 3V6
Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Canada
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4
Canada
McGill University
Montreal, Quebec, H2W 1S6
Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2
Canada
Additional Information:
Study ID Numbers: CDR0000069214; CAN-NCIC-LY8
Study Start Date: January 2001
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031668
Other Anaplastic Large Cell Lymphoma Studies:
1. Radiation Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma Who Have Undergone Stem Cell Transplantation
2. Liposomal Vincristine in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma
3. Arsenic Trioxide in Treating Patients With Relapsed or Refractory Non- Hodgkin's Lymphoma
4. 506U78 in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma or T-cell Lymphoma
5. 506U78 in Treating Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Related Studies:
Other anaplastic large cell lymphoma Clinical Trials
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Other Edmonton Clinical Trials
Radiation Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma Who Have Undergone Stem Cell Transplantation
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