Early Stage Mycosis Fungoides Cutaneous T Cell Lymphoma (MF-CTCL) (Stage IA-IB) Clinical Trial
— REACHOfficial title:
Study to Determine the Aetiology of Chlormethine Gel Induced-skin Drug Reaction in Early Stage Mycosis Fungoides Cutaneous T Cell Lymphoma (MF-CTCL)
| Verified date | September 2023 |
| Source | European Organisation for Research and Treatment of Cancer - EORTC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Terminated |
| Enrollment | 2 |
| Est. completion date | April 4, 2023 |
| Est. primary completion date | April 4, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| European Organisation for Research and Treatment of Cancer - EORTC |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Response Rate (ORR) for all patients and in groups A, B and C. | The response status - complete response (CR), partial response (PR), stable disease (SD) and disease progression (PD) - will be assessed using the global response assessment: skin, lymph nodes (not involved at entry), viscera (not involved at entry) and blood (absolute value CD4+CD7- and CD4+CD26- circulating population) as per EORTC-ISCL-USCLC guidelines | 2.5 years from first patient in |