Alemtuzumab in Treating Patients With Relapsed or Refractory Advanced Mycosis Fungoides or Sézary Syndrome

This study is ongoing, but not recruiting participants.
Millennium Pharmaceuticals, Inc.
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Timothy Kuzel, Northwestern University Identifier:
First received: April 7, 2003
Last updated: February 23, 2016
Last verified: February 2016

RATIONALE: Monoclonal antibodies such as alemtuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: This phase II trial is studying how well alemtuzumab works in treating patients with relapsed or refractory advanced mycosis fungoides or Sézary syndrome.

Condition Intervention Phase
Biological: alemtuzumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial Of Campath-1H In Patients With Relapsed/Refractory Advanced Mycosis Fungoides or Sezary Syndrome

Resource links provided by NLM:

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Determine response rate associated with Campath-1H therapy in patients with relapsed Mycosis Fungoides/Sezary Syndrome [ Time Frame: At baseline, weekly while on treatment, then once when patient goes off study ] [ Designated as safety issue: No ]
    Response rate associated with Campath-1H therapy in patients with relapsed Mycosis Fungoides/Sezary Syndrome will be assessed by medical photograph (skin lesion) measurements or by CT scan for internal lesions upon study entry, weekly while on study, then once when patient goes off study

  • Collect data on toxicity associated with Campath-1H therapy [ Time Frame: At baseline and then every 2 weeks while on therapy ] [ Designated as safety issue: Yes ]
    Toxicity of this drug will be assessed upon study entry and then every 2 weeks while on therapy by blood tests

Estimated Enrollment: 37
Study Start Date: July 2000
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment arm
Biological: alemtuzumab
Will be administered as a two-hour IV infusion with a target dose of 30 milligrams three times a week for a maximum of 12 weeks.
Other Names:
  • Campath
  • MabCampath
  • Campath-1H

Detailed Description:


  • Determine the response rate of patients with relapsed or recurrent advanced mycosis fungoides or Sézary syndrome treated with alemtuzumab.
  • Determine the toxicity of this drug in these patients.

OUTLINE: Patients receive alemtuzumab IV over 2 hours three times per week. Treatment continues for up to 12 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 2 years.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Histologically confirmed mycosis fungoides or Sézary syndrome

    • Stage IB-IVB
  • Measurable disease

    • One or more indicator lesions
    • No prior radiotherapy to areas of measurable disease unless there is clear disease progression at the site or measurable disease outside the area of prior radiotherapy
    • Generalized erythrodermia patients with evaluable disease only are allowed
  • Must have failed at least 1 prior systemic therapy



  • 18 and over

Performance status

  • ECOG 0-2 OR
  • WHO 0-2

Life expectancy

  • At least 3 months


  • WBC at least 3,000/mm^3
  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 2.2 mg/dL
  • AST or ALT no greater than 2 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2 times ULN


  • Creatinine no greater than 2.0 mg/dL


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No acute infection requiring intravenous antibiotics
  • No other prior neoplasm except treated squamous cell or basal cell skin cancer, treated carcinoma in situ of the cervix, or other cancer that received surgical treatment only from which patient has been disease free for at least 5 years


Biologic therapy

  • More than 4 weeks since prior biologic therapy


  • More than 4 weeks since prior chemotherapy

Endocrine therapy

  • More than 4 weeks since prior topical steroids


  • See Disease Characteristics
  • At least 2 weeks since prior radiotherapy (local control or palliative)
  • No concurrent radiotherapy to any lesion


  • Recovered from prior major surgery


  • Recovered from prior therapy
  • No other concurrent proven or investigational antineoplastic agents
  Contacts and Locations
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Please refer to this study by its identifier: NCT00057967

United States, Illinois
Northwestern University, Northwestern Medical Faculty Foundation
Chicago, Illinois, United States, 60611-3013
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, United States, 60611-4494
Sponsors and Collaborators
Northwestern University
Millennium Pharmaceuticals, Inc.
Genzyme, a Sanofi Company
Principal Investigator: Timothy M. Kuzel, MD Northwestern University
  More Information

Responsible Party: Timothy Kuzel, Timothy Kuzel, MD, Northwestern University Identifier: NCT00057967     History of Changes
Other Study ID Numbers: NU 99H8  NU 99H8  STU00012258 
Study First Received: April 7, 2003
Last Updated: February 23, 2016
Health Authority: United States: Federal Government
United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Northwestern University:
recurrent mycosis fungoides/Sezary syndrome
stage I mycosis fungoides/Sezary syndrome
stage II mycosis fungoides/Sezary syndrome
stage III mycosis fungoides/Sezary syndrome
stage IV mycosis fungoides/Sezary syndrome
recurrent cutaneous T-cell non-Hodgkin lymphoma
stage I cutaneous T-cell non-Hodgkin lymphoma
stage II cutaneous T-cell non-Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma

Additional relevant MeSH terms:
Mycosis Fungoides
Sezary Syndrome
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents processed this record on May 26, 2016