REACH: Study to Determine the Aetiology of Chlormethine Gel Induced-skin Drug Reaction in Early Stage Mycosis Fungoides Cutaneous T Cell Lymphoma (MF-CTCL)

NCT ID: NCT04218825

Last Updated: 2023-11-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-29
• Study Completion Date: 2023-04-04

Brief Summary

Adult patients with early stage MF-CTCL (stage IA-IB) will be eligible for this study. A total of 100 early stage MF-CTCL patients diagnosed in the past year will be enrolled.

Treatment with CL gel will be applied once daily to all skin areas affected by MF-CTCL and, for 8 weeks, one selected skin area unaffected by MF-CTCL (0.5% body surface area) until treatment response (complete response), study treatment duration completed (56 weeks), progression, or another withdrawal criterion is met.

Depending on the type of skin drug-related reaction (if any) occurring after application of CL gel, this study will categorize patients into three different groups corresponding to three different treatment patterns:

• Group A: Patients with no skin drug reaction with CL gel application
• Group B: Patients developing a skin drug reaction of any grade with CL gel application, not due to allergic reaction to CL gel, will continue treatment at reduced application frequency
• Group C: Patients from Group B unable to tolerate reduced CL gel application frequency will apply a potent topical steroid twice daily in addition to CL gel applied every other day

Conditions

Early Stage Mycosis Fungoides Cutaneous T Cell Lymphoma (MF-CTCL) (Stage IA-IB)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adult patients with early stage MF-CTCL (stage IA-IB)

Patients are treated with Chlormethine gel (CL) gel. In case of any skin drug reaction, allergic test will be carried out. Patients not allergic to CL gel will continue at reduced application frequency, with the addition of topical steroid if necessary.

Group Type: EXPERIMENTAL

chlormethine gel

Intervention Type: DRUG

Gel to be applied to all skin areas affected by MF-CTCL

Interventions

chlormethine gel

Gel to be applied to all skin areas affected by MF-CTCL

Intervention Type: DRUG

Other Intervention Names

Ledaga®

Eligibility Criteria

Inclusion Criteria

• Diagnosis of MF-CTCL stage IA or IB at enrolment as per ISCL/EORTC revision to the MF and Sézary syndrome classification and MF stage should have never met the criteria for stage IIA or higher in the patient medical history
• Lesions cover less than 80% of BSA
• Age ≥ 18
• ECOG/WHO performance status 0-2

Exclusion Criteria

• Previous treatment with CL gel
• Concurrent or planned local or systemic anti-CTCL therapy
• Prior treatment with antihistamines or narrow band UV-B or PUVA therapy one week before enrolment, or systemic corticosteroids or radiotherapy in the last 4 weeks before enrolment
• Prior treatment with topical steroids in the patch test area (upper back) one week before enrolment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julia Scarisbrick, MD

Role: STUDY_CHAIR

UHB-Queen Elisabeth Medical Centre, Birmingham, United Kingdom

Emmanuella Guenova, MD

Role: STUDY_CHAIR

Centre Hospitalier Universitaire Vaudois - Lausanne, Lausanne, Switzerland

Locations

CHU de Bordeaux - Groupe Hospitalier Saint-Andre - Hopital Saint-Andre

Bordeaux, , France

Assistance Publique Hopitaux Paris- APHP - APHP Nord - Univ De Paris Cite - Hop. Saint Louis

Paris, , France

Countries

France

Other Identifiers

2019-004891-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EORTC-1754-CLTF

Identifier Type: -

Identifier Source: org_study_id