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Safety and Efficacy of 90Y Zevalin in Nonmyeloablative Transplantation for Lymphoid Malignancies 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 Safety and Efficacy of 90Y Zevalin in Nonmyeloablative Transplantation for Lymphoid Malignancies conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Safety and Efficacy of 90Y Zevalin in Nonmyeloablative Transplantation for Lymphoid Malignancies Clinical research trials and Safety and Efficacy of 90Y Zevalin in Nonmyeloablative Transplantation for Lymphoid Malignancies 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 Safety and Efficacy of 90Y Zevalin in Nonmyeloablative Transplantation for Lymphoid Malignancies. Safety and Efficacy of 90Y Zevalin in Nonmyeloablative Transplantation for Lymphoid Malignancies 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 Safety and Efficacy of 90Y Zevalin in Nonmyeloablative Transplantation for Lymphoid Malignancies clinical trial. Participants typically obtain the most effective healthcare available for their Safety and Efficacy of 90Y Zevalin in Nonmyeloablative Transplantation for Lymphoid Malignancies 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 > "S" Clinical Trials Conditions > Safety and Efficacy of 90Y Zevalin in Nonmyeloablative Transplantation for Lymphoid Malignancies  Safety and Efficacy of 90Y Zevalin in Nonmyeloablative Transplantation for Lymphoid Malignancies
Safety and Efficacy of 90Y Zevalin in Nonmyeloablative Transplantation for Lymphoid Malignancies
For Condition: Chronic Lymphocytic Leukemia,Lymphoma
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center ,
Synopsis: This is a phase I/II study to determine the safety and efficacy of nonmyeloablative allogeneic stem cell transplantation using 90Y Zevalin/Cyclophosphamide/Fludarabine as a preparative regimen for patients with B-cell lymphoid malignancies.
Details: Nonmyeloablative transplantation with fludarabine/cyclophosphamide/rituximab and allogeneic transplantation is a promising therapy for B-cell lymphoid malignancies. However, results are less optimal for patients with bulky and refractory disease where only 20 to 30% of patients are alive and in remission at 2 years. Clinical studies demonstrated superiority of single agent 90Y Zevalin radioimmunotherapy to rituximab as therapy for NHL. A dose of 0.4 m Ci/kg Y2B8 was associated with minimal toxicity. Using this agent with fludarabine/cyclophosphamide could provide a better tumor control until the graft-versus-tumor effect generated by the infusion of donor stem cells initiates its biological activity. An escalating dose of 0.2 0.3 0.4 m Ci/kg Y2B8 will be used to assess safety and then efficacy of the highest dose.
Eligibility:
Study Type: Interventional,Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Relapsed or refractory CD20-positive B-cell NHL or CLL. - No anti-cancer therapy for four weeks, counted from first day (six weeks if Rituximab, nitrosourea or Mitomycin C) prior to study initiation, and fully recovered from all toxicities associated with prior surgery, radiation treatments, chemotherapy, or immunotherapy - An IRB-approved signed informed consent - Age: 18 to 70 years of age - Expected survival: > 3 months - Prestudy performance status of 0, 1, or 2 according to the WHO (see Appendix C) - Female patients who are not pregnant or lactating - Men and women of reproductive potential who are following accepted birth control methods (as determined by the treating physician, however abstinence is not an acceptable method) - Patients previously on Phase II drugs if no long-term toxicity is expected, and the patient has been off the drug for four or more weeks with no significant post treatment toxicities observed - Patients determined to have < 50% bone marrow involvement with lymphoma or CLL within four weeks of registration (define measurement of a bone marrow aspirate or biopsy) and CLL patients with < 10,000 circulating lymphocytes. Exclusion Criteria - Prior myeloablative therapies with autologous or allogeneic bone marrow transplantation (ABMT) or peripheral blood stem cell (PBSC) rescue - Prior radioimmunotherapy - Presence of CNS lymphoma
Total Enrollment: 30
Location and Contact Information:
MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting Issa Khouri 713-745-2803
Additional Information:
Study ID Numbers: ID01-233; IND 10258
Study Start Date: October 2002
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00048737
Other Chronic Lymphocytic Leukemia Studies:
1. Fludarabine and Cyclophosphamide Followed by Peripheral Stem Cell Transplantation in Treating Patients With Leukemia or Lymphoma
2. Flavopiridol, Fludarabine, and Rituximab in Treating Patients With Lymphoproliferative Disorders or Mantle Cell Lymphoma
3. Autologous T Cell Immunotherapy for Chronic Lymphocytic Leukemia (CLL) Patients
4. Megadose CD34 Selected Progenitor Cells for Transplantation in Patients with Advanced Hematological Malignant Diseases
5. Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults
Related Studies:
Other Chronic Lymphocytic Leukemia Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Safety and Efficacy of 90Y Zevalin in Nonmyeloablative Transplantation for Lymphoid Malignancies
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