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Phase I Study of T-Cell Large Granular Lymphocytic Leukemia Using the MIK-Beta-1 Monoclonal Antibody Directed Toward the IL-2R-Beta Subunit Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Phase I Study of T-Cell Large Granular Lymphocytic Leukemia Using the MIK-Beta-1 Monoclonal Antibody Directed Toward the IL-2R-Beta Subunit conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Phase I Study of T-Cell Large Granular Lymphocytic Leukemia Using the MIK-Beta-1 Monoclonal Antibody Directed Toward the IL-2R-Beta Subunit Clinical research trials and Phase I Study of T-Cell Large Granular Lymphocytic Leukemia Using the MIK-Beta-1 Monoclonal Antibody Directed Toward the IL-2R-Beta Subunit healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Phase I Study of T-Cell Large Granular Lymphocytic Leukemia Using the MIK-Beta-1 Monoclonal Antibody Directed Toward the IL-2R-Beta Subunit. Phase I Study of T-Cell Large Granular Lymphocytic Leukemia Using the MIK-Beta-1 Monoclonal Antibody Directed Toward the IL-2R-Beta Subunit Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Phase I Study of T-Cell Large Granular Lymphocytic Leukemia Using the MIK-Beta-1 Monoclonal Antibody Directed Toward the IL-2R-Beta Subunit clinical trial. Human subjects often receive the most effective healthcare possible for their Phase I Study of T-Cell Large Granular Lymphocytic Leukemia Using the MIK-Beta-1 Monoclonal Antibody Directed Toward the IL-2R-Beta Subunit condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Phase I Study of T-Cell Large Granular Lymphocytic Leukemia Using the MIK-Beta-1 Monoclonal Antibody Directed Toward the IL-2R-Beta Subunit  Phase I Study of T-Cell Large Granular Lymphocytic Leukemia Using the MIK-Beta-1 Monoclonal Antibody Directed Toward the IL-2R-Beta Subunit
Phase I Study of T-Cell Large Granular Lymphocytic Leukemia Using the MIK-Beta-1 Monoclonal Antibody Directed Toward the IL-2R-Beta Subunit
For Condition: Agranulocytosis,Pure Red Cell Aplasia,T Cell Leukemia,Thrombocytopenia
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: The purpose of the study is to evaluate the toxicity and clinical response following multiple-dose administration of murine Mik-Beta-1 directed toward IL-2R-Beta in patients with IL-2R-Beta-expressing T-cell large granular lymphocytic (T-LGL) leukemia associated with granulocytopenia, thrombocytopenia, or anemia. This study represents an extension of Metabolism Branch IL-2R-directed monoclonal antibody therapy studies for patients with leukemia. The scientific basis for the proposed therapeutic studies is that the monoclonal lymphocytes of patients with T-LGL leukemia express large numbers of the IL-2R-Beta subunit identified by Mik-Beta-1 on their cell surfaces, whereas most normal resting cells of patients do not. Furthermore, Mik-Beta-1 prevents IL-2-mediated proliferation and activation into lymphokine-activated killer cells of T-LGL mediated by IL-2 when it is added to T-LGL leukemia cells. We propose to administer murine Mik-Beta-1 at doses of 0.5, 1.0, and 1.5 mg/kg per dose to three groups of five patients with IL-2R-Beta-expressing monoclonal T-LGL leukemia cells and associated granulocytopenia, thrombocytopenia, or anemia. The antibody will be administered intravenously to patients over 18 years of age who fulfill the patient eligibility criteria. The antibody will be administered at the doses indicated above on days 1, 4, 7, and 10 of the study. Clinical response will be evaluated using routine hematological and clinical evaluation, by monitoring the phenotype of circulating IL-2R-expressing leukemic T cells, and by Southern blot analysis of the arrangement of the gene encoding the Beta and Gamma subunits of the T-cell antigen receptor.
Details: The purpose of the study is to evaluate the toxicity and clinical response following multiple-dose administration of murine Mik-beta-1 directed toward IL-2R-beta in patients with IL-2R-beta-expressing T-cell large granular lymphocytic (T-LGL) leukemia associated with granulocytopenia, thrombocytopenia, or anemia. This study represents an extension of Metabolism Branch IL-2R-beta-directed monoclonal antibody therapy studies for patients with leukemia. The scientific basis for the proposed therapeutic studies is that the monoclonal lymphocytes of patients with T-LGL leukemia express large numbers of the IL-2R-beta subunit identified by Mik-beta-1 on their cell surfaces, whereas most normal resting cells of patients do not. Furthermore, Mik-beta-1 prevents IL-2R-beta mediated proliferation and activation into lymphokine-activated killer cells of T-LGL mediated by IL-2 when it is added to T-LGL leukemia cells. We propose to administer murine Mik-beta-1 at doses of 0.5, 1.0, and 1.5 mg/kg per dose to three groups of five patients with IL-2R-beta-expressing monoclonal T-LGL leukemia cells and associated granulocytopenia, thrombocytopenia, or anemia. The antibody will be administered intravenously to patients over 18 years of age who fulfill the patient eligibility criteria. The antibody will be administered at the doses indicated above on days 1, 4, 7, and 10 of the study. Clinical response will be evaluated using routine hematological and clinical evaluation, by monitoring the phenotype of circulating IL-2R-expressing leukemic T cells, and by Southern blot or polymerase chain reaction (PCR) analysis of the arrangement of the gene encoding the beta and gamma subunits of the T-cell antigen receptor.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: All patients must have histologically confirmed T-LGL leukemia and clinically significant hematocytopenia (absolute neutrophil count less than 1,000/mm(3), hemoglobin less than 8 g/percent or platelet count less than 50,000/mm(3)). Upon entry in the study, patients must have clinically evaluable disease with a peripheral blood population of T-LGL leukemia cells expressing the CD3+, CD8+ phenotype detectable by FACS. The circulating monoclonal cells must contain a monoclonal T-cell population as demonstrated by analysis of TCR beta or gamma chain gene rearrangement. Patients with T-LGL leukemia without as well as with previous chemotherapy, therapy with corticosteroids, interferon or G-CSF will be eligible for inclusion in the study. Patients on a stable dose of G-CSF, GM-CSF, IL or similar sustained release/long acting product (e.g., pegylated G-CSF) for 4-weeks or longer will be eligible for the study. Omission of chemotherapy or interferon is required for 4 weeks prior to entry into the trial. However, patients receiving corticosteroids must be on a stable dose for at least 3 weeks before receiving Mik-beta 1 on this study. Normal renal function (creatinine less than 2.0 mg/dl) and hepatic function (direct bilirubin less than 1.5 mg/dl). Patients must have a Karnofsky performance status of at least 50. Patients must have a life expectancy greater than 2 months. Patients must be able to understand and sign the informed consent. Patients must be at least 18 years old. EXCLUSION CRITERIA: Female patients of childbearing potential will be tested for pregnancy; pregnant patients will be excluded from the study. Patients who are HIV-antibody positive will be excluded from the study. Patients with a second primary cancer other than basal cell carcinoma of the skin will be excluded from the study. A recent (within 4 wk) history of active major bleeding. Patients who have episodes of fever without an apparent site of infection may begin protocol medication while on antibiotics as long as cultures do not reveal a pathogenic organism and the patient has been afebrile (maximum temperature less than 38 degrees C) for at least 5 days.
Total Enrollment: 25
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 950054; 95-C-0054
Study Start Date: January 18, 1995
Record last reviewed: April 30, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001425
Other Agranulocytosis Studies:
1. Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune Diseases
2. Phase I Study of T-Cell Large Granular Lymphocytic Leukemia Using the MIK-Beta-1 Monoclonal Antibody Directed Toward the IL-2R-Beta Subunit
3. A Study to Determine whether Therapy with Daclizumab Will Benefit Patients with Bone Marrow Failure
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Phase I Study of T-Cell Large Granular Lymphocytic Leukemia Using the MIK-Beta-1 Monoclonal Antibody Directed Toward the IL-2R-Beta Subunit
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