Early Stage Mycosis Fungoides Cutaneous T Cell Lymphoma (MF-CTCL) (Stage IA-IB)Phase 2REACHNCT04218825

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

A Phase 2 study testing chlormethine gel in people with Early Stage Mycosis Fungoides Cutaneous T Cell Lymphoma (MF-CTCL) (Stage IA-IB), run by European Organisation for Research and Treatment of Cancer - EORTC at 2 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Early Stage Mycosis Fungoides Cutaneous T Cell Lymphoma (MF-CTCL) (Stage IA-IB)
What is being tested?: chlormethine gel
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 2 sitesFrance
Study dates: 29 Mar 2022to 4 Apr 2023
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

France2 sites

CHU de Bordeaux - Groupe Hospitalier Saint-Andre - Hopital Saint-Andre
Bordeaux
Assistance Publique Hopitaux Paris- APHP - APHP Nord - Univ De Paris Cite - Hop. Saint Louis
Paris, 75010

Other trials in France

About this study

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)

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)
Being tested: chlormethine gel
Keywords: mycosis fungoides (MF), cutaneous T cell lymphoma (CTCL)
Medical subject headings: Mycosis Fungoides, Lymphoma, T-Cell, Cutaneous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

chlormethine gelDrug
Also called Ledaga®
Gel to be applied to all skin areas affected by MF-CTCL

Study groups in NCT04218825
Study group	Role	What they receive
Adult patients with early stage MF-CTCL (stage IA-IB)	Experimental	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. Receives: Drug: chlormethine gel

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 2.5 years from first patient in

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Mar 20224 Apr 2023

First posted6 Jan 2020
Study start29 Mar 2022
Primary completion4 Apr 2023
Study completion4 Apr 2023

Why it stopped: After an extensive assessment of the study feasibility, it was decided to discontinue the clinical trial due to poor recruitment.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Early Stage Mycosis Fungoides Cutaneous T Cell Lymphoma (MF-CTCL) (Stage IA-IB)Studies of the same condition, open and under way.
More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04218825
Sponsor's protocol ID: EORTC-1754-CLTF
Other IDs: 2019-004891-20, 2019
Acronym: REACH
Status last verified: Sep 2023
First submitted: 3 Jan 2020
Last updated: 9 Nov 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT04218825
Acronym / sponsor ID: REACH / EORTC-1754-CLTF
Conditions: Early Stage Mycosis Fungoides Cutaneous T Cell Lymphoma (MF-CTCL) (Stage IA-IB)
Keywords: mycosis fungoides (MF), cutaneous T cell lymphoma (CTCL)
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: After an extensive assessment of the study feasibility, it was decided to discontinue the clinical trial due to poor recruitment.
Enrolment: 2 participants (actual)
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTCResearch network
Study start: 29 Mar 2022 (actual)
Primary completion: 4 Apr 2023 (actual)
Study completion: 4 Apr 2023 (actual)
First posted: 6 Jan 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Adult patients with early stage MF-CTCL (stage IA-IB)	Experimental	Drug: chlormethine gelPatients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
chlormethine gelAlso: Ledaga®Gel to be applied to all skin areas affected by MF-CTCL	Drug	Adult patients with early stage MF-CTCL (stage IA-IB)

Primary outcome

Overall Response Rate (ORR) for all patients and in groups A, B and C.
Time frame: 2.5 years from first patient in
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

Results and safety

The study was stopped early (reason given: After an extensive assessment of the study feasibility, it was decided to discontinue the clinical trial due to poor recruitment.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Julia Scarisbrick, MD study chair

UHB-Queen Elisabeth Medical Centre, Birmingham, United Kingdom

Emmanuella Guenova, MD study chair

Centre Hospitalier Universitaire Vaudois - Lausanne, Lausanne, Switzerland

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) for all patients and in groups A, B and C. (time frame: 2.5 years from first patient in). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04218825.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.