NCT04218825: REACH

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

Terminated Phase 2 Last updated 9 November 2023

What this trial tests

Phase 2 trial testing chlormethine gel in Early Stage Mycosis Fungoides Cutaneous T Cell Lymphoma (MF-CTCL) (Stage IA-IB) in 2 participants. Terminated before completion.

Timeline

29 March 2022

Primary endpoint
4 April 2023

4 April 2023

Quick facts

Lead sponsor	European Organisation for Research and Treatment of Cancer - EORTC
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	2
Start date	29 March 2022
Primary completion	4 April 2023
Estimated completion	4 April 2023
Sites	2 locations across France

Drugs / interventions tested

• chlormethine gel — full drug profile →

Conditions studied

• Early Stage Mycosis Fungoides Cutaneous T Cell Lymphoma (MF-CTCL) (Stage IA-IB) — all drugs for Early Stage Mycosis Fungoides Cutaneous T Cell Lymphoma (MF-CTCL) (Stage IA-IB) →

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC — full company profile →

Who can join

18 and older, any sex, with Early Stage Mycosis Fungoides Cutaneous T Cell Lymphoma (MF-CTCL) (Stage IA-IB). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Chlormethine Gel for the Treatment of Skin Lesions in All Stages of Mycosis Fungoides Cutaneous T-Cell Lymphoma: A Narrative Review and International Experience.
   Geskin LJ, Bagot M, Hodak E, Kim EJ. · · 2021 · cited 22× · PMID 34021485 · DOI 10.1007/s13555-021-00539-3
2. Post hoc Analysis of a Randomized, Controlled, Phase 2 Study to Assess Response Rates with Chlormethine/Mechlorethamine Gel in Patients with Stage IA-IIA Mycosis Fungoides.
   Querfeld C, Scarisbrick JJ, Assaf C, Guenova E, et al · · 2022 · cited 11× · PMID 34091453 · DOI 10.1159/000516138
3. Chlormethine Gel for Patients with Mycosis Fungoides Cutaneous T Cell Lymphoma: A Review of Efficacy and Safety in Clinical Trial and Real-World Settings.
   Wehkamp U, Ardigò M, Papadavid E, Querfeld C, et al · · 2022 · cited 10× · PMID 35852707 · DOI 10.1007/s12325-022-02219-w
4. Chlormethine Gel Versus Chlormethine Ointment for Treatment of Patients with Mycosis Fungoides: A Post-Hoc Analysis of Clinical Trial Data.
   Querfeld C, Scarisbrick JJ, Assaf C, Kim YH, et al · · 2022 · cited 6× · PMID 35536441 · DOI 10.1007/s40257-022-00687-y