Leukemia (Adult)
Phase II Study of the Efficacy and Toxicity of CAMPATH-1H in the Therapy of Adult T-Cell Leukemia
NCI-03-C-0194
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Investigator(s): |
John C. Morris, M.D. Principal Investigator Phone: 301-402-2912 jmorris@mail.nih.gov
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John E. Janik, M.D. Protocol Chair Phone: 301-402-2913 janikj@mail.nih.gov
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Suzanne Fioravanti, R.N., B.S.N., O.C.N. Research Nurse Phone: 301-594-6544 Fax: 301-402-1001 fioravas@mail.nih.gov
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Primary Eligibility:
- Histologically confirmed adult T-cell leukemia (ATL)/lymphoma
- HTLV-1-positive
- Acute, lymphomatous or chronic stage disease
- Measurable disease (defined as ≥ 10% abnormal peripheral blood mononuclear cells or measurable tumor)
- No symptomatic leukemic meningitis
- No prior alemtuzumab therapy
- > 3 weeks since prior chemotherapy for ATL and no concurrent anticancer chemotherapy
Treatment Plan:
- Patients will receive escalating doses of alemtuzumab intravenously (IV) once daily until the target dose is reached and tolerated
- Patients will then receive the target dose of alemtuzumab IV over 2 hours 3 times weekly for up to a total of 12 weeks in the absence of disease progression or unacceptable toxicity
- Patients will be 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 annually thereafter
Additional Information:
- This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
- There is no charge for medical care received at NIH Clinical Center.
- FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
- PDQ (Physicians Data Query) - provides additional details about this study for health care providers.
Reviewed: 6/18/08
Updated: 12/11/06