Know Cancer

forgot password

Phase II Study of the Efficacy and Toxicity of Campath-1H in the Therapy of Adult T-Cell Leukemia

Phase 2
18 Years
Not Enrolling
Acute T-Cell Leukemia-Lymphoma

Thank you

Trial Information

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.

Inclusion Criteria:

- Patients must have serum antibodies directed to Human T-lymphotropic Virus Type 1

- All patients must have a histologically confirmed diagnosis of adult T- cell
leukemia/lymphoma and more than 10% of the malignant cells must express CD52 and

- All stages of Tac-expressing adult T-cell leukemia except smoldering are eligible:
patients with chronic, lymphoma or acute Acute T-cell leukemia/lymphoma (ATL) are

- Patients must have measurable disease. All patients with greater than 10% abnormal
(i.e. Tac homogeneous strongly expressing) peripheral blood mononuclear cell (PBMC)in
the peripheral blood will be deemed to have measurable disease.

- The patient must have a granulocyte count of at least 100/mm(3) and a platelet count
of greater than or equal to 50,000/mm(3).

- Patients must have a creatinine of less than 3.0 mg/dl.

- Omission of cytotoxic chemotherapy for ATL for 3 weeks prior to entry into the trial
is required. However patients receiving a stable dose of corticosteroids for at least
three to four weeks without evidence of tumor response will be eligible.

- Patients must have a life expectancy of greater than 2 months.

- Eligible patients must be greater than or equal to 18 years old. There is no upper
age limit.

- Patients must have serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic
pyruvic transaminase (SGPT) value less than or equal to 2.5-fold greater than the
upper limit of normal and bilirubin less than or equal to 3.0/dl. If a liver function
test is judged to be elevated due to the underlying ATL, this parameter will be
considered an unevaluable parameter for toxicity determinations.

- Patients must be able to understand and sign an Informed Consent form.

- All patients must use adequate contraception during participation in this trial and
for three months after completing therapy.

Exclusion Criteria:

- Patients with symptomatic leukemic meningitis will be excluded. However patients that
have both ATL and another HTLV-1-associated disease, tropical spastic paraparesis
(TSP) will be included.

- Pregnant and nursing patients are not eligible for the study. Because the effects of
CAMPATH-1H on the developing fetus are unknown pregnant women will be excluded.
Breast-feeding in patients with HTLV-1 infection is contraindicated because of the
risk of transmission of the virus to the child. In addition, CAMPATH-1H may be
present in breast milk and produce adverse events in the breast-feeding child.

- Human immunodeficiency virus (HIV) positive patients are excluded from the study.
CAMPATH-1H may produce a different pattern of toxicities in patients with HIV
infection and in addition the depletion of T cells produced by CAMPATH-1H may have
adverse effects on HIV positive individuals.

- Patients with smoldering ATL are excluded.

- Patients with previously received Campath-1GH are ineligible.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response Rate

Outcome Description:

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.

Outcome Time Frame:

60 months

Safety Issue:


Principal Investigator

Thomas A Waldmann, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:



United States: Federal Government

Study ID:




Start Date:

May 2003

Completion Date:

July 2012

Related Keywords:

  • Acute T-Cell Leukemia-Lymphoma
  • Monoclonal Antibody
  • HTLV-1
  • CD52
  • Flow Cytometry
  • Antibody Saturation
  • Adult T-Cell Leukemia (ATL)
  • ATL
  • Leukemia
  • Leukemia, T-Cell
  • Leukemia-Lymphoma, Adult T-Cell
  • Lymphoma
  • Precursor T-Cell Lymphoblastic Leukemia-Lymphoma



National Institutes of Health, National Cancer Institute Bethesda, Maryland  20892