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

Cutaneous T-cell Lymphoma (CTCL) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00476554
• Other study ID #: CYC682-06-05
• Status: Terminated
• Phase: Phase 2
• Start date: April 2007
• Est. completion date: March 1, 2012

Study information

• Verified date: December 2021
• Source: Cyclacel Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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.

Other known NCT identifiers

• NCT00475995

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: March 1, 2012
• Est. primary completion date: March 1, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cutaneous T-cell Lymphoma (CTCL)
• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous

Intervention

Drug:
• Sapacitabine
Sapacitabine

Locations

Country	Name	City	State
United States	Timothy Kuzel, M.D.	Chicago	Illinois
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Stanford University Hospitals and Clinics	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Cyclacel Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate in overall skin disease	Decrease of lesion from baseline	over the course of study