Phase II Study of the Efficacy and Toxicity of Campath-1H in the Therapy of Adult T-Cell Leukemia
Adult T-cell leukemia/lymphoma (ATL) is an aggressive lymphoproliferative disorder caused by
an infection with the human T-cell lymphotrophic virus type-1 (HTLV-1).
ATL is characterized by rapidly rising peripheral blood leukemia cell counts,
lymphadenopathy, lytic bone lesions, hepatosplenomegaly, and skin and solid organ
involvement by tumor.
Chemotherapy has shown modest activity and the treatment of ATL has remained largely
undefined and the survival of ATL patients poor.
The CD52 surface glycoantigen is overexpressed on ATL cells.
Alemtuzumab (Campath-1H) is a humanized rat monoclonal antibody that binds to CD52 and is
In preclinical models, Campath-1H inhibited tumor growth and improved the survival of
Non-obese diabetic (NOD)/severe combined immune deficiency (SCID) mice injected with human
MET-1 ATL cells.
To determine the efficacy of Campath-1H in the treatment of ATL.
To define the time course of Campath-1H saturation in patients with ATL.
To define the toxicity of Campath-1H in patients with ATL.
Patients with HTLV-I-associated adult T-cell leukemia.
More than 10% of the malignant cells must express CD52 and CD25.
Patients must have measurable disease.
The patient must have a granulocyte count of at least 1000/mm(3) and a platelet count of
greater than or equal to 50,000/mm(3).
A single institution non-randomized open-label Phase II trial.
This trial will recruit a maximum of 30 eligible patients.
Patients will receive antimicrobial and antiviral prophylaxis while on-study due to the
known immunosuppressive effects of Campath-1H.
Patients will receive I.V. Campath-1H 3 mg on day 1, 10 mg on day 2, and 30 mg day 3
followed by maintenance Campath-1H 30 mg I.V. three time per week.
Patients will be evaluated for response and continuation of Campath-1H therapy after weeks 4
and 8 of maintenance treatment.
Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate
Overall response rate is defined as the percentage of participants with response and utilizes the International Standardized workshop definition. Complete response(CR)-Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related symptoms if present before therapy and normalization of those biochemical abnormalities (for example LDH) definitely assignable to the lymphoma. Please see the protocol Link module for the full criteria if desired.
Thomas A Waldmann, M.D.
United States: Federal Government
|National Institutes of Health, National Cancer Institute||Bethesda, Maryland 20892|