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



Status:Recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/25/2019
Start Date:December 19, 2017
End Date:August 2019
Contact:Galderma R&D
Email:frnceclinicaltrials@galderma.com
Phone:817-961-5120

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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

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

To assess the efficacy and safety of two concentrations (0.03% and 0.06%) of CD11301 gel in
the treatment of early stage CTCL (stage IA, IB, or IIA) versus placebo.

Inclusion Criteria:

- 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:

- 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 subject is in exclusion period from a
previous clinical trial
We found this trial at
13
sites
Boston, Massachusetts 02115
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Chicago, Illinois
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Dallas, Texas 75230
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Durham, North Carolina 27710
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Farmington, Connecticut 06032
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Houston, Texas 77004
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Nashville, Tennessee 37203
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Orange, California 92868
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Palo Alto, California 94304
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Pflugerville, Texas 78660
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Philadelphia, Pennsylvania 19103
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Pierre-Bénite, Auvergne-Rhône-Alpes 69310
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Pittsburgh, Pennsylvania 15213
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