Study of WP1220 for the Treatment of Adult Subjects With Cutaneous T-Cell Lymphoma (CTCL)

NCT04702503 | Completed Phase 1

• 1 other identifier: MB-201
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Single center, pilot study to evaluate the safety and efficacy topical administration of WP1220 in subjects with Stage I, II or III Mycosis Fungoides (CTCL)

Conditions

Cutaneous T-Cell Lymphoma/Mycosis Fungoides

Outcome Measures

Primary Outcomes (1)

• Evaluation of the safety profile of WP1220 applied topically (adverse events)

  Safety will be evaluated by reported adverse events

  12 weeks (3 28-day cycles)

Secondary Outcomes (1)

• Evaluation of WP1220 applied topically to index lesions via standard measurement scale

  12 weeks

Study Arms (1)

10% WP1220 ointment

EXPERIMENTAL

10% WP1220 ointment topically applied 2x day for 84 days

Drug: WP1220

Interventions

WP1220 DRUG

Topical administration 2x daily for 84 consecutive days

10% WP1220 ointment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years at the time of signing informed consent.
• Clinical diagnosis of MF.
• Stage IA, IB, IIA, IIB, or II MF: T1-T4 with measurable lesions
• Previously treatment with at least one standard therapy used to treat Stage IA, IB, IIA, IIB, or III MF.
• Measurable skin disease must have at least 2 eligible baseline index lesions with maximum total area ≤ 40 cm2. Eligible lesions must be below the head (face and scalp are excluded) and must not involve the genitalia or anus.
• ECOG performance status of 0-2
• Subject must read and sign informed consent form and be willing to comply with the instructions, restrictions, nature and procedures of the study.
• Willing to avoid tanning devices or exposure of the treated skin to the sun.
• Willing to not use cosmetics, including lotions, creams, and moisturizers on the treated lesions.
• Willing to use topical steroid on a maximum of 25% of BSA occupied by MF on areas not involved in the clinical trial.
• Must have recovered from the effects of surgery requiring general anesthesia and intubation for a minimum of 3 months, and from minor surgery requiring only local anesthetic for a minimum of 2 weeks.
• Concomitant disease must be stable and subjects must be on the same dose and schedule of any medications for at least 1 month before screening.
• Subjects of both genders who are of childbearing potential including perimenopausal women who are fewer than 2 years from their last menses, must use one of the following effective means of contraceptionL
• Birth control pills in conjunction with spermicide gel
• Surgical sterilization

You may not qualify if:

• MF with no prior therapy.
• Subjects with a diagnosis of stage IV MF at Screening or subsequently observed at Baseline.
• Subjects with unusual phenotypes, e.g. lymphomatoid papulosis MF-like type.
• Subjects who require immediate treatment for progressive MF.
• Subjects treated with at least one of the following methods within 8 weeks prior to
• Baseline:
• Total body electron beam radiation
• Investigational drugs or treatments
• Subjects treated with at least one of the following methods within 4 weeks prior to
• Baseline:
• Local radiation therapy
• UVB therapy
• PUVA
• Topical chemotherapy
• Topical corticosteroids or retinoids

Sponsors & Collaborators

• Moleculin Biotech, Inc.: lead

Study Sites (1)

Medical University of Gdansk

Gdansk, Poland

Location

MeSH Terms

Conditions

Mycosis Fungoides

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell, Cutaneous; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Sandra Silberman, MD, PhD

  Moleculin Biotech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: January 11, 2021
• Study Start: March 8, 2019
• Primary Completion: November 15, 2019
• Study Completion: November 15, 2020
• Last Updated: January 11, 2021

Record last verified: 2021-01

Locations

PL (1)