Clinical trial NCT04218825: REACH: Study to Determine the Aetiology of Chlormethine Gel Induced-skin Drug Reaction in Early Stage Mycosis Fungoides Cutaneous T Cell Lymphoma (MF-CTCL)
Official title: Study to Determine the Aetiology of Chlormethine Gel Induced-skin Drug Reaction in Early Stage Mycosis Fungoides Cutaneous T Cell Lymphoma (MF-CTCL)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Early Stage Mycosis Fungoides Cutaneous T Cell Lymphoma (MF-CTCL) (Stage IA-IB)
Keywords: mycosis fungoides (MF)
cutaneous T cell lymphoma (CTCL)
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2020-01-06
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Overall Response Rate (ORR) for all patients and in groups A, B and C.
timeFrame: 2.5 years from first patient in
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux - Groupe Hospitalier Saint-Andre - Hopital Saint-Andre
city: Paris
country: France
facility: Assistance Publique Hopitaux Paris- APHP - APHP Nord - Univ De Paris Cite - Hop. Saint Louis
Study officials:
affiliation: UHB-Queen Elisabeth Medical Centre, Birmingham, United Kingdom
name: Julia Scarisbrick, MD
role: STUDY_CHAIR
affiliation: Centre Hospitalier Universitaire Vaudois - Lausanne, Lausanne, Switzerland
name: Emmanuella Guenova, MD
role: STUDY_CHAIR
References: