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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02520908
Other study ID # NI 14018
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 23, 2016
Est. completion date November 19, 2024

Study information

Verified date April 2024
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 98
Est. completion date November 19, 2024
Est. primary completion date November 19, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Intervention

Procedure:
HSCT
Hematopoietic stem cell transplantation
Other:
Standard Care


Locations

Country Name City State
France Saint Louis hospital Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-Free Survival (PFS) 3 year
Secondary overall survival (OS) 3 year
Secondary Neutrophils Engraftment Neutrophils > 1,000 Giga/L 180 days
Secondary Acute and chronic graft-versus-host disease (GVHD) 180 days
Secondary Cumulative incidence of relapse 3 years
Secondary Treatment-related mortality (TRM) 12 months
Secondary Quality of life (QoL) 3 years