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Rituximab and Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Rituximab and Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Rituximab and Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma Clinical research trials and Rituximab and Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Rituximab and Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma. Rituximab and Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Rituximab and Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma clinical trial. Subjects frequently get the best healthcare possible for their Rituximab and Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Rituximab and Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma  Rituximab and Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Rituximab and Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
For Condition: recurrent adult immunoblastic large cell lymphoma,recurrent diffuse small lymphocytic/marginal zone lymphoma,recurrent adult diffuse small cleaved cell lymphoma,recurrent adult diffuse small noncleaved cell/Burkitt's lymphoma,recurrent mantle cell lymphoma,recurrent grade III follicular large cell lymphoma,recurrent adult diffuse mixed cell lymphoma,recurrent adult diffuse large cell lymphoma,recurrent grade I follicular small cleaved cell lymphoma,recurrent grade II follicular mixed cell lymphoma
Status: No longer recruiting
Sponsor(s): University of Nebraska ,
Synopsis: RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of rituximab and combination chemotherapy followed by bone marrow or peripheral stem cell transplantation in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.
Details: OBJECTIVES: I. Determine the complete and partial response rate of patients with relapsed or refractory B-cell non-Hodgkin's lymphoma treated with rituximab and high-dose carmustine, etoposide, cytarabine and melphalan followed by autologous bone marrow or peripheral blood stem cell transplantation. II. Determine the toxicity profile of this regimen in these patients. III. Compare the levels of soluble CD20 antigen and rituximab blood levels with patient outcomes in this patient population. PROTOCOL OUTLINE: Patients receive two doses of rituximab IV over 3-4 hours 1 week apart. Stem cells from the peripheral blood or bone marrow are collected at least 1 week after the second dose of rituximab. Following stem cell collection, patients receive a third dose of rituximab IV as above between days -10 and -6. Patients then receive high-dose chemotherapy consisting of carmustine IV on day -6, etoposide IV twice daily and cytarabine IV on days -5 to -2, and melphalan IV on day -1. On day 0 patients undergo autologous bone marrow or peripheral blood stem cell transplantation. After transplantation, patients receive a fourth dose of rituximab as above at approximately day 30, and then weekly over 4 weeks at approximately 6 months in the absence of disease progression or unacceptable toxicity. Patients are followed at 1 year and then annually thereafter. PROJECTED ACCRUAL: A total of 23-40 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 19 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Diagnosis of CD20-positive B-cell non-Hodgkin's lymphoma; Transplantation candidate Primary induction failure; Chemotherapy refractory disease; Received at least 3 prior chemotherapy regimens OR Diagnosis of mantle cell lymphoma - No history of T-cell lymphoma - No relapse or progression after rituximab therapy within 3 months before transplantation --Prior/Concurrent Therapy-- - Biologic therapy: See Disease Characteristics - Chemotherapy: See Disease Characteristics; No other concurrent chemotherapy - Endocrine therapy: No concurrent corticosteroids except for transient control or prevention of nausea or vomiting; Concurrent non-steroidal hormones for non-lymphoma-related conditions (e.g., insulin for diabetes) allowed - Radiotherapy: No concurrent external beam radiotherapy during transplantation therapy - Surgery: Not specified - Other: No other concurrent antitumoral or investigational agents --Patient Characteristics-- - Age: 19 and over - Performance status: WHO 0-2 - Life expectancy: At least 6 months - Hematopoietic: Absolute neutrophil count at least 1,000/mm3*; Platelet count more than 50,000/mm3*; Hemoglobin more than 9.0 g/dL* *Unless due to lymphomatous involvement of the marrow - Hepatic: Not specified - Renal: Not specified - Other: No serious disease or condition that would preclude study; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JulieVose, Study Chair, University of Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
Additional Information:
Study ID Numbers: CDR0000068305; NCI-V00-1634,UNMC-045-00
Study Start Date: September 2000
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00007852
Other Recurrent Adult Diffuse Mixed Cell Lymphoma Studies:
1. Paclitaxel and Estramustine in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
2. 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
3. Combination Chemotherapy in Treating Patients With Hodgkin's Disease or Non-Hodgkin's Lymphoma That Has Not Responded to Previous Treatment
4. Rituximab and Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
5. Combination Chemotherapy in Treating Patients With Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma, or Multiple Myeloma
Related Studies:
Other recurrent adult diffuse mixed cell lymphoma Clinical Trials
Other Nebraska Clinical Trials
Other Omaha Clinical Trials
Rituximab and Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
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