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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00064155 |
RATIONALE: Monoclonal antibodies such as alemtuzumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: This phase II trial is studying how well alemtuzumab works in treating patients with HTLV-1 associated adult T-cell leukemia/lymphoma.
Condition | Intervention | Phase |
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Lymphoma |
Drug: alemtuzumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of the Efficacy and Toxicity of Campath-1H in the Therapy of Adult T-Cell Leukemia |
Estimated Enrollment: | 29 |
Study Start Date: | May 2003 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a nonrandomized study.
Each patient receives escalating doses of alemtuzumab IV once daily until the target dose is reached and tolerated. Patients then receive the target dose of alemtuzumab IV over 2 hours 3 times weekly for a total of 12 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly until the CD4 count has recovered and then every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 9-29 patients will be accrued for this study within 2.5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adult T-cell leukemia (ATL)/lymphoma
HTLV-1-associated disease
Measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Patient Recruitment 888-NCI-1937 |
Study Chair: | John C. Morris, MD | NCI - Metabolism Branch;MET |
Study ID Numbers: | CDR0000309057, NCI-03-C-0194, NCI-4553 |
Study First Received: | July 8, 2003 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00064155 |
Health Authority: | Unspecified |
recurrent adult T-cell leukemia/lymphoma stage I adult T-cell leukemia/lymphoma stage II adult T-cell leukemia/lymphoma stage III adult T-cell leukemia/lymphoma stage IV adult T-cell leukemia/lymphoma |
Lymphatic Diseases Leukemia Leukemia, Lymphoid Immunoproliferative Disorders Alemtuzumab |
Leukemia-Lymphoma, Adult T-Cell Leukemia, T-Cell Lymphoproliferative Disorders Lymphoma Recurrence |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |