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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                                                                                      Print this page 


Investigator(s):

John C. Morris, M.D.
Principal Investigator
Phone: 301-402-2912
jmorris@mail.nih.gov

John E. Janik, M.D.
Protocol Chair
Phone: 301-402-2913
janikj@mail.nih.gov

Referral Contact(s):

Suzanne Fioravanti, R.N., B.S.N., O.C.N.
Research Nurse
Phone: 301-594-6544
Fax: 301-402-1001
fioravas@mail.nih.gov

 

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

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