A Randomized Phase II Study of Oral Sapacitabine in Patients With Advanced Cutaneous T-cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00476554
Recruitment Status : Terminated (slow accrual and financial resource limitation)
First Posted : May 22, 2007
Last Update Posted : November 9, 2011
Information provided by (Responsible Party):
Cyclacel Pharmaceuticals, Inc.

Brief Summary:
This is an open label, randomized phase II study designed to evaluate the tolerability and response rate of high-dose and low-dose regimens in patients with advanced cutaneous T-cell lymphoma (CTCL) who have had progressive, recurrent, or persistent disease on or following 2 systemic therapies.

Condition or disease Intervention/treatment Phase
Cutaneous T-cell Lymphoma (CTCL) Drug: Sapacitabine Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2007
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: A
low dose
Drug: Sapacitabine

Experimental: B
High dose
Drug: Sapacitabine

Primary Outcome Measures :
  1. response rate in overall skin disease [ Time Frame: over the course of study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patients with advanced CTCL
  • Have had at least 2 systemic therapies
  • Must have evaluable disease
  • Eastern Cooperative Oncology Group performance status 0-2
  • Adequate bone marrow, hepatic and renal function
  • At least 3 weeks from prior therapies
  • Not receiving topical steroids or have been on a stable dose of topical steroids for at least 2 weeks
  • Able to swallow capsules
  • At least 3 weeks from major surgery
  • Agree to practice effective contraception
  • Able to understand and willing to sign the informed consent form

Exclusion Criteria:

  • Receiving systemic steroids
  • Receiving topical or systemic retinoids or vitamin A
  • Receiving radiotherapy, biological therapy,or any other investigational agents
  • Uncontrolled intercurrent illness
  • Pregnant or lactating women
  • Known to be HIV-positive
  • Active hepatitis B and/or hepatitis C infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00476554

United States, California
Stanford University Hospitals and Clinics
Stanford, California, United States, 94305
United States, Illinois
Timothy Kuzel, M.D.
Chicago, Illinois, United States, 60611
United States, Texas
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
Cyclacel Pharmaceuticals, Inc.
Study Director: Judy H Chiao, M.D. Cyclacel Pharmaceuticals, Inc.

Responsible Party: Cyclacel Pharmaceuticals, Inc. Identifier: NCT00476554     History of Changes
Obsolete Identifiers: NCT00475995
Other Study ID Numbers: CYC682-06-05
First Posted: May 22, 2007    Key Record Dates
Last Update Posted: November 9, 2011
Last Verified: November 2011

Keywords provided by Cyclacel Pharmaceuticals, Inc.:

Additional relevant MeSH terms:
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin