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Alemtuzumab in Treating Patients With HTLV-1 Associated Adult T-Cell Leukemia/Lymphoma
This study is ongoing, but not recruiting participants.
Study NCT00064155   Information provided by National Cancer Institute (NCI)
First Received: July 8, 2003   Last Updated: April 21, 2009   History of Changes

July 8, 2003
April 21, 2009
May 2003
March 2009   (final data collection date for primary outcome measure)
Clinical response every month during treatment, monthly for 3 months, and then every 3 months for a year [ Designated as safety issue: No ]
Clinical response every month during treatment, monthly for 3 months, and then every 3 months for a year
Complete list of historical versions of study NCT00064155 on ClinicalTrials.gov Archive Site
Saturation of CD52 every month during treatment, monthly for 3 months, and then every 3 months for a year [ Designated as safety issue: No ]
Saturation of CD52 every month during treatment, monthly for 3 months, and then every 3 months for a year
 
Alemtuzumab in Treating Patients With HTLV-1 Associated Adult T-Cell Leukemia/Lymphoma
Phase II Study of the Efficacy and Toxicity of Campath-1H in the Therapy of Adult T-Cell Leukemia

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.

OBJECTIVES:

  • Determine the efficacy of alemtuzumab in patients with HTLV-1-associated adult T-cell leukemia/lymphoma.
  • Determine the time course of alemtuzumab saturation in these patients.
  • Determine the toxicity of this drug in these patients.

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.

Phase II
Interventional
Treatment, Open Label
Lymphoma
Biological: alemtuzumab
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
29
 
March 2009   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed adult T-cell leukemia (ATL)/lymphoma

    • More than 10% of malignant cells must express CD52 and CD25
    • All stages of tac-expressing ATL are eligible, including chronic or acute disease
    • No smoldering ATL
  • HTLV-1-associated disease

    • Must have serum antibodies directed to HTLV-1
  • Measurable disease

    • Greater than 10% abnormal (i.e., Tac homogenous strongly expressing) peripheral blood mononuclear cells considered to be measurable disease
  • No symptomatic leukemic meningitis

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Not specified

Life expectancy

  • More than 2 months

Hematopoietic

  • Granulocyte count at least 1,000/mm^3
  • Platelet count at least 50,000/mm^3

Hepatic

  • SGOT and SGPT no greater than 2.5 times upper limit of normal
  • Bilirubin no greater than 3.0 mg/dL

Renal

  • Creatinine less than 3.0 mg/dL

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • HIV negative
  • Other concurrent HTLV-1-associated diseases (e.g., tropical spastic paraparesis) are allowed

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior alemtuzumab
  • No other concurrent monoclonal antibody therapy
  • No concurrent gammaglobulins
  • No concurrent biological response modifiers (e.g., interferon or similar agents)

Chemotherapy

  • More than 3 weeks since prior cytotoxic chemotherapy for ATL
  • No concurrent FDA-approved or investigational anticancer chemotherapy

Endocrine therapy

  • Concurrent stable dose corticosteroids (administered for at least 3-4 weeks) allowed provided there is no evidence of tumor response

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • No other concurrent investigational anticancer agents
  • No concurrent zidovudine
  • No concurrent drug that affects lymphocytes, except corticosteroids
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00064155
John Charles Morris, NCI - Metabolism Branch;MET
CDR0000309057, NCI-03-C-0194, NCI-4553
National Cancer Institute (NCI)
 
Study Chair: John C. Morris, MD NCI - Metabolism Branch;MET
National Cancer Institute (NCI)
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP