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

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02520908
• Collaborator: (none)
• Enrollment: 98
• Location: 1
• Anticipated Duration (Months): 97.7
• Patients Per Site Per Month: 1

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Epidermotropic T-cell Lymphomas	Procedure: HSCT; Other: Standard Care

Study Design

• Study Type: Observational
• Actual Enrollment: 98 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prospective, Controlled, Multicenter Cohort Study Evaluating the Benefit of Allogeneic Haematopoietic Stem Cells in Cutaneous T-cell Lymphomas Epidermotropic With Advanced Stage and Poor Prognosis
• Actual Study Start Date: Sep 28, 2016
• Anticipated Primary Completion Date: Nov 19, 2024
• Anticipated Study Completion Date: Nov 19, 2024

Arms and Interventions

Arm	Intervention/Treatment
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; 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	Other: Standard Care

Outcome Measures

Primary Outcome Measures

1. Progression-Free Survival (PFS) [3 year]

Secondary Outcome Measures

1. overall survival (OS) [3 year]

2. Neutrophils Engraftment [180 days]

   Neutrophils > 1,000 Giga/L

3. Acute and chronic graft-versus-host disease (GVHD) [180 days]

4. Cumulative incidence of relapse [3 years]

5. Treatment-related mortality (TRM) [12 months]

6. Quality of life (QoL) [3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Saint Louis hospital	Paris		France	75010

Sponsors and Collaborators

• Assistance Publique - Hôpitaux de Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT02520908
• Other Study ID Numbers: NI 14018
• First Posted: Aug 13, 2015
• Last Update Posted: Apr 18, 2022
• Last Verified: Apr 1, 2022

• Additional relevant MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous

Study Results

No Results Posted as of Apr 18, 2022