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A Phase I Study of Alefacept (AmeviveTM) in the Treatment of Cutaneous T-cell Lymphoma and Peripheral T-cell NHL

Phase 1
18 Years
Open (Enrolling)

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Trial Information

A Phase I Study of Alefacept (AmeviveTM) in the Treatment of Cutaneous T-cell Lymphoma and Peripheral T-cell NHL



- Determine the maximum tolerated dose or the optimal immunologic dose of alefacept in
patients with relapsed or refractory cutaneous T-cell lymphoma or peripheral T-cell
non-Hodgkin's lymphoma.


- Determine if antitumor activity of this drug exists in these patients.

OUTLINE: This is a multicenter, dose-escalation study.

- Induction therapy: Patients receive alefacept IV over 2-5 minutes once weekly for up to
8 weeks in the absence of disease progression or unacceptable toxicity. Patients with
stable disease or complete or partial response after induction therapy proceed to
maintenance therapy.

Cohorts of 6 patients receive escalating doses of alefacept until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients
experience dose-limiting toxicity. The optimal immunologic dose is defined as the dose that
does not exceed the MTD, has the highest alefacept level, and achieves saturation of CD2

- Maintenance therapy: Patients receive alefacept IV on day 1. Treatment repeats every 4
weeks for 10-12 courses in the absence of disease progression or unacceptable toxicity.

Patients who experience disease progression during maintenance therapy may receive
reinduction therapy* comprising 4 weekly doses of alefacept. The patient then proceeds to a
second maintenance phase in the absence of disease progression.

NOTE: *Only 1 reinduction allowed.

Patients undergo blood and tissue collection periodically for pharmacological studies. Blood
serum is analyzed for alefacept concentration, cytokine concentration, CD16 polymorphisms,
and CD2 saturation via flow cytometry.

After completion of study treatment, patients are followed every 3 months for up to 3 years
and then periodically thereafter.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed cutaneous T-cell lymphoma (CTCL) or peripheral T-cell
non-Hodgkin's lymphoma

- Diagnostic biopsies must have been obtained within the past 6 months

- Relapsed or refractory disease

- Patients with CTCL must have failed ≥ 2 skin-directed therapies

- No limit on the number of prior therapies

- Measurable disease, defined as at least 1 bidimensionally measurable lesion > 2 cm by
CT scan, MRI, physical exam, or photograph with appended ruler

- At least 2 bidimensionally measurable target lesions required for patients with
skin lesions only

- No CNS lymphoma


- ECOG performance status 0-2

- Absolute neutrophil count ≥ 1,000/mm^3

- Platelet count ≥ 75,000/mm^3

- Hemoglobin ≥ 9 g/dL

- Total bilirubin ≤ 2 times upper limit of normal (ULN) OR direct bilirubin ≤ 1.5 times

- AST ≤ 3 times ULN (≤ 5 times ULN if liver involvement)

- Creatinine ≤ 2 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Willing to provide all research blood samples as required by the protocol

- Willing to undergo repeat biopsy of either an accessible skin lesion or lymph node,
if there are no circulating sezary cells, for the purpose of research studies
(patients without easily accessible lesions are not required to have a repeat biopsy
solely for research purposes but must be willing to provide a portion of the on-study
biopsy or a previous lymphoma biopsy, if available)

- No known congenital or acquired immunodeficiency syndromes, including HIV

- No known active viral hepatitis or tuberculosis infection

- No uncontrolled infection

- No other uncontrolled serious medical condition unrelated to lymphoma (e.g., cardiac
arrhythmia or diabetes)

- No other active malignancies

- No history of serious allergic reaction to citrate or glycine


- See Disease Characteristics

- More than 3 weeks since prior cytotoxic chemotherapy

- More than 3 weeks since prior denileukin diftitox

- More than 3 weeks since prior radiotherapy (less than 3 weeks if the acute side
effects of this therapy are resolved)

- More than 2 weeks since prior oral corticosteroids (unless being used to treat
adrenal insufficiency)

- More than 2 weeks since prior phototherapy, including ultraviolet B and psoralen with
ultraviolet A

- More than 1 week since prior biologic therapy

- No concurrent chemotherapy, other immunotherapy, or radiotherapy

- No other concurrent investigational agents

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

9/21/2006 - 7/06/2010

Safety Issue:


Principal Investigator

Thomas E. Witzig, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

March 2006

Completion Date:

May 2013

Related Keywords:

  • Lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • angioimmunoblastic T-cell lymphoma
  • anaplastic large cell lymphoma
  • adult nasal type extranodal NK/T-cell lymphoma
  • recurrent mycosis fungoides/Sezary syndrome
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous



Mayo Clinic Cancer Center Rochester, Minnesota  55905
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
City of Hope Comprehensive Cancer Center Duarte, California  91010