NCT06651203: KISS01

Evaluation of the KIR3DL2 Marker in Flow Cytometry for Sézary Syndrome Diagnosis, Therapeutic Response and Residual Disease: a Prospective and Multicenter Study

Not yet recruiting Last updated 21 October 2024

What this trial tests

trial testing Follow-up in Mycosis Fungoides/Sezary Syndrome in 460 participants. Not yet recruiting.

Timeline

1 November 2024

Primary endpoint
1 November 2027

1 November 2029

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Status	Not yet recruiting
Study type	OBSERVATIONAL
Enrollment	460
Start date	1 November 2024
Primary completion	1 November 2027
Estimated completion	1 November 2029

Drugs / interventions tested

• Follow-up

Conditions studied

• Mycosis Fungoides/Sezary Syndrome — all drugs for Mycosis Fungoides/Sezary Syndrome →
• Cutaneous T Cell Lymphoma — all drugs for Cutaneous T Cell Lymphoma →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, any sex, with Mycosis Fungoides/Sezary Syndrome or Cutaneous T Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Cutaneous T-cell lymphomas (CTCL) are a group of primary cutaneous lymphomas including Mycosis Fungoides (MF) and Sézary syndrome (SS). SS is characterized by erythroderma and high numbers of circulating atypical lymphocytes (Sézary cells. SCs). Blood staging was added to the Tumor Node Metastasis (TNM) classification of MF/SS, reflecting the broad spectrum of CTCLs and the poor prognosis related to blood involvement. Blood classes were defined using blood-smear manual counts. However, this method never reached an international consensus status because of its subjective nature and its poor sensitivity. Several markers have been identified with variable efficiency for MF/SS diagnosis, outcome prediction and blood response to treatment. Such markers are essential for sharing and publishing consistent data about diagnosis, staging, prognosis and response to therapies. The detection of SCs is based on the lack of pan T-cell markers such as CD7 and/or CD26, which is not constant and may be observed in benign dermatoses. Thus, patients are often diagnosed with a delay, even treated with inappropriate therapies which worsens their prognosis. The relevance of blood-class in MF/SS is not only related to stage but also contributes to the response to therapy in clinical trials. We found that a significant proportion of benign T-cells from SS patients are CD4+CD26-, which may underestimate the rate of complete response to treatment. The identification of KIR3DL2 on SCs by our team has greatly helped the detailed study of the malignant clone. We have recently published two ancillary studies demonstrating the specificity and reliability of KIR3DL2 as a positive marker for SCs, and its prognosis value at initial diagnosis. We have designed an optimized flow-cytometry strategy as part of the routine care of erythrodermic patients at Saint-Louis Hospital and published in 2019 the results of a 5 years prospective single-center study involving 254 CTCL patients at initial diagnosis. We provided recommendations with the use a threshold value of KIR3DL2+SCs ≥ 200/µL or KIR3DL2+SCs/lymphocytes ≥ 10% in the diagnostic criteria and proposed a novel algorithm blood staging.

Several innovative immunotherapies in phase I/II trials or under compassionate use are ongoing in French centers, with the need to assess blood response using positive markers. Our goal is to validate KIR3DL2 as a specific marker for SS and to assess its reliability for blood staging and response to treatment in a multicenter study (11 centers).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.