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

NCT02520908 | Active Not Recruiting

• 1 other identifier: NI 14018
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  3 year

Secondary Outcomes (6)

• overall survival (OS)

  3 year

• Neutrophils Engraftment

  180 days

• Acute and chronic graft-versus-host disease (GVHD)

  180 days

• Cumulative incidence of relapse

  3 years

• Treatment-related mortality (TRM)

  12 months

Study Arms (2)

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

Procedure: HSCT

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

Other: Standard Care

Interventions

HSCT PROCEDURE

Hematopoietic stem cell transplantation

HSCT

Standard Care OTHER

Standard care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Advanced-stage epidermotropic T-cell lymphomas (ETCL), i.e. mycosis fungoides (MF) and its leukemic variant, Sézary syndrome

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Saint Louis hospital

Paris, 75010, France

Location

Related Publications (2)

• 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.

  PMID: 37105210 BACKGROUND

• 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.

  PMID: 40513043 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

During the blood samples usually performed in routine patient management, 30 ml of peripheral blood will be collected at inclusion and one year after inclusion and sent to the investigator's central collection laboratory (INSERM UMRS 976, Saint-Louis Hospital, Paris, France).

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2015
• First Posted: August 13, 2015
• Study Start: September 23, 2016
• Primary Completion: November 19, 2024
• Study Completion: November 19, 2024
• Last Updated: May 1, 2024

Record last verified: 2024-04

Locations

FR (1)