Benefit of Allogeneic Haematopoietic Stem Cells in Cutaneous T-cell Lymphomas Epidermotropic With Advanced Stage and Poor Prognosis

NCT ID: NCT02520908

Last Updated: 2024-05-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 98 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-23
• Study Completion Date: 2024-11-19

Brief Summary

Epidermotropic T-cell lymphomas (ETCL), i.e. mycosis fungoides (MF) and its leukemic variant, Sézary syndrome, are the most frequent subtypes of cutaneous T-cell lymphomas. MF typically runs an indolent course in its early stages. By contrast, advanced-stage ETCLs share a very bad prognosis: Patients usually show early relapses after chemotherapy, prolonged complete remissions exceptionally occur and quality of life is severely affected. Several publications have reported durable responses following allogeneic hematopoietic stem cell transplantation (HSCT) in advanced-stage ETCLs. This study aims to investigate the role of allogeneic HSCT in treating advanced-stage ETCLs. An observational, prospective, multicenter, controlled study will compare the outcomes of patients who receive reduced-intensity conditioned allogeneic HSCT from a sibling or 10/10 HLA-matched unrelated donor to those of patients who receive standard of care in patients with advanced-stage ETCL with poor prognostic features, will be performed. Patients are included at the time of donor search irrespective of the results, and compared on a donor versus no donor basis. It is an observational study since no intervention is made except the comparison of outcomes of groups that receive usual care (HSCT if donor available, or not).

Conditions

Epidermotropic T-cell Lymphomas

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

HSCT

Patients with an available sibling or 10/10 HLA-matched unrelated donor who undergo reduced-intensity conditioned allogeneic hematopoietic stem cell transplantation (HSCT), will be included in the study. The reduced-intensity conditioning usually includes Fludarabine 90 mg/m2 IV and Melphalan 140 mg/m2 IV. As usual care, patients will receive peripheral blood stem cells from their sibling donor if available, otherwise from their 10/10 HLA-matched unrelated donor

HSCT

Intervention Type: PROCEDURE

Hematopoietic stem cell transplantation

Standard care

Patients with no available sibling or 10/10 HLA-matched unrelated donor who therefore do not receive allogeneic HSCT but receive best standard of care treatment, will be included in the study, as the control group

Standard Care

Intervention Type: OTHER

Interventions

HSCT

Hematopoietic stem cell transplantation

Intervention Type: PROCEDURE

Standard Care

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 and ≤ 65 years
• Histopathologically confirmed diagnosis of International Society for Cutaneous Lymphomas (ISCL) / European Organisation for Research and Treatment of Cancer (EORTC) stage IIB, III, IVA or IVB ETCL
• Complete or partial response of the lymphoma (as defined by the international ISCL-EORTC criteria at the time of inclusion
• Written informed consent given by the patient
• Contraception in women of childbearing age
• Hematopoietic stem cell donor search underway

And at least one of the three following criteria:

• Refractoriness or early relapse (i.e. within one year) after at least one line of systemic chemotherapy (not including skin-directed therapies, methotrexate, interferon-alpha, and oral retinoids)
• Early histological large-cell transformation, i.e. within two years following ETCL diagnosis
• Histologically proven nodal (ISCL / EORTC N3) or extra-cutaneous visceral involvement by the lymphoma

Exclusion Criteria

• Prior allogeneic HSCT
• Other progressive neoplastic disease
• Progressive psychotic disease
• Left ventricular ejection fraction < 50% (as determined by trans-thoracic echocardiography)
• Pulmonary disease with FEV1, FVC or DLCO <30% of expected corrected for hemoglobin.
• Creatinine clearance <50 ml/min or requiring dialysis
• Transaminases or bilirubin >two-fold the normal value in the absence of liver involvement by the lymphoma
• Pregnant or breastfeeding woman
• Patient with no health coverage
• Patient under guardianship or curatorship
• HTLV-1 lymphoma

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Saint Louis hospital

Paris, , France

Countries

France

References

de Masson A, Beylot-Barry M, Ram-Wolff C, Mear JB, Dalle S, d'Incan M, Ingen-Housz-Oro S, Orvain C, Abraham J, Dereure O, Charbonnier A, Cornillon J, Longvert C, Barete S, Boulinguez S, Wierzbicka-Hainaut E, Aubin F, Rubio MT, Bernard M, Schmidt-Tanguy A, Houot R, Pham-Ledard A, Michonneau D, Brice P, Labussiere-Wallet H, Bouaziz JD, Grange F, Moins-Teisserenc H, Jondeau K, Michel L, Mourah S, Battistella M, Daguindau E, Loschi M, Picard A, Franck N, Maillard N, Huynh A, Nguyen S, Marcais A, Chaby G, Ceballos P, Le Corre Y, Maury S, Bay JO, Adamski H, Bachy E, Forcade E, Socie G, Bagot M, Chevret S, Peffault de Latour R; CUTALLO Investigators; Groupe Francais d'Etude des Lymphomes Cutanes; Societe Francaise de Greffe de Moelle et Therapie Cellulaire. Allogeneic transplantation in advanced cutaneous T-cell lymphomas (CUTALLO): a propensity score matched controlled prospective study. Lancet. 2023 Jun 10;401(10392):1941-1950. doi: 10.1016/S0140-6736(23)00329-X. Epub 2023 Apr 24.

Reference Type: BACKGROUND

PMID: 37105210 (View on PubMed)

de Masson A, Beylot-Barry M, Ram-Wolff C, Mear JB, Dalle S, Rouanet J, Ingen-Housz-Oro S, Orvain C, Abraham J, Dereure O, Charbonnier A, Cornillon J, Longvert C, Barete S, Boulinguez S, Wierzbicka-Hainaut E, Aubin F, Rubio MT, Bernard M, Schmidt-Tanguy A, Houot R, Pham-Ledard A, Michonneau D, Labussiere-Wallet H, Bouaziz JD, Grange F, Moins-Teisserenc H, Jondeau K, Mourah S, Battistella M, Daguindau E, Loschi M, Picard A, Franck N, Maillard N, Huynh A, Nguyen S, Marcais A, Chaby G, Ceballos P, Le Corre Y, Maury S, Bay JO, Adamski H, Bachy E, Forcade E, Socie G, Bagot M, Chevret S, Peffault de Latour R; CUTALLO Investigators, Groupe Francais d'Etude des Lymphomes Cutanes and Societe Francaise de Greffe de Moelle et Therapie Cellulaire. Overall Survival After Allogeneic Transplantation in Advanced Cutaneous T-Cell Lymphomas (CUTALLO): A Propensity Score-Matched Controlled Prospective Study. J Clin Oncol. 2025 Aug;43(22):2461-2466. doi: 10.1200/JCO-25-00183. Epub 2025 Jun 13.

Reference Type: DERIVED

PMID: 40513043 (View on PubMed)

Other Identifiers

NI 14018

Identifier Type: -

Identifier Source: org_study_id