A Safety, Efficacy and Pharmacokinetics Study of CD11301 for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)

Trial ID or NCT#

NCT03292406

Status

not recruiting iconNOT RECRUITING

Purpose

To assess the efficacy, safety and pharmacokinetics in participants treated with CD11301 gel vs. placebo for early stage CTCL (IA, IB, or IIA).

Official Title

A Randomized, Double-blind, Multi-centre, Placebo-controlled, Parallel-arm Phase 2 Trial to Assess Safety, Efficacy and Pharmacokinetics of CD11301 0.03% and 0.06% Gel in the Treatment of Cutaneous T-Cell Lymphoma (CTCL), Stages IA, IB and IIA

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Clinical Diagnosis of CTCL stage IA, IB, or IIA with biopsy within last 3 months - Have BSA involvement corresponding to stages IA, IB or IIA CTCL with at least 3 distinct lesions
Exclusion Criteria:
  1. - CTCL that is stage IIB or great or stage IIA with stage N2 with >5% circulating Sezary cells or CD8+ or large cell transformation or Progressive CTCL - History of autoimmune disease - Laboratory test values at screening outside of the normal range and judged clinically significant by the investigator - Current participation in another clinical trial of a drug or device or past participation within 4 weeks before Baseline or participant is in exclusion period from a previous clinical trial
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Investigator(s)

Youn H Kim, MD
Youn H Kim, MD
Dermatologic oncologist, Cutaneous oncology specialist, Dermatologist
The Joanne and Peter Haas, Jr., Professor for Cutaneous Lymphoma Research and Professor, by courtesy, of Medicine (Oncology)
Michael Khodadoust
Michael Khodadoust
Lymphoma specialist, Cutaneous oncology specialist, Hematologist, Hematologist-Oncologist
Assistant Professor of Medicine (Oncology) and of Dermatology

Contact us to find out if this trial is right for you.

Contact

Sydney Yee
650-721-6118

View on ClinicalTrials.gov