Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02520908
Recruitment Status : Recruiting
First Posted : August 13, 2015
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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
Epidermotropic T-cell Lymphomas Procedure: HSCT Other: Standard Care

Layout table for study information
Study Type : Observational
Estimated Enrollment : 78 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
Study Start Date : July 2016
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Group/Cohort 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



Primary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: 3 year ]

Secondary Outcome Measures :
  1. overall survival (OS) [ Time Frame: 3 year ]
  2. Neutrophils Engraftment [ Time Frame: 180 days ]
    Neutrophils > 1,000 Giga/L

  3. Acute and chronic graft-versus-host disease (GVHD) [ Time Frame: 180 days ]
  4. Cumulative incidence of relapse [ Time Frame: 3 years ]
  5. Treatment-related mortality (TRM) [ Time Frame: 12 months ]
  6. Quality of life (QoL) [ Time Frame: 3 years ]

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).


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02520908


Contacts
Layout table for location contacts
Contact: Adèle de Masson, MD +33142494949 adele.de-masson@inserm.fr
Contact: Régis Péffault de la Tour, MD PhD +33142494949 regis.peffaultdelatour@aphp.fr

Locations
Layout table for location information
France
Saint Louis hospital Recruiting
Paris, France, 75010
Contact: Adèle de Masson, MD       adele.de-masson@inserm.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris

Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02520908     History of Changes
Other Study ID Numbers: NI 14018
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin