Observational Study of the Combination of Post-transplant High Dose Cyclophosphamide, Tacrolimus and Mycophenolate Mofetil for the Prevention of Acute Graft-versus-Host Disease in Patients Eligible to Allogeneic Hematopoietic Stem Cell Transplant
An Observational Retrospective/Prospective Study of the Combination of Post-transplant High Dose Cyclophosphamide, Tacrolimus and Mycophenolate Mofetil for the Prevention of Acute Graft-versus-Host Disease in Patients Eligible to Allogeneic Hematopoietic Stem Cell Transplant Using Peripheral Blood Stem Cells (PBSC) From Unrelated or Related, HLA-identical or Partially Mismatched Donors
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Allogeneic hematopoietic cell transplantation (HCT) remains the only curative approach for many hematological malignancies. In allogeneic HCT the donor immune system through the donor lymphocytes exerts both a beneficial and detrimental effect. Graft versus host disease (GVHD) represents the major complication and cause of mortality of allogeneic HCT. The principal aim that clinical transplant research must accomplish in the next years is to elaborate a transplant strategy devoid of any GVHD but still capable of generating, through donor lymphocytes, the graft versus tumor effect (GVT). The most used GVHD prophylaxis regimen remains the association of a calcineurin-inhibitor (CNIs) for six months and four low-doses of methotrexate (MTX) but the long length prophylaxis impacts on the process of post-transplant immune reconstitution slowing it down and exposing patients to a high risk of developing severe infections. The use of post-transplant cyclophosphamide looks the most promising among the new approaches to GVHD control. The study design is an observational retrospective/prospective Study in Patients Eligible to Allogeneic Hematopoietic Stem Cell Transplant using Peripheral Blood Stem Cells (PBSC) from unrelated or related, HLA-identical or partially mismatched donors. In case of unrelated donor, donor selection will be done accordingly to Italian Bone Marrow Donor Registry (IBMDR). This protocol and the treatment plan outlined below are limited to the plan or GVHD prevention.
The treatment plan for all patients including pre-conditioning therapy, TBI/chemotherapy, central nervous system prophylaxis and other planned therapies, is described in the primary transplant protocols which the patient has been assigned by the investigational site.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Fabrizio Carnevale-Schianca, MD
- Número de teléfono: 3623 +39011993
- Correo electrónico: fabrizio.carnevale@ircc.it
Copia de seguridad de contactos de estudio
- Nombre: Daniela Caravelli, MD
- Número de teléfono: 3623 +39011993
- Correo electrónico: daniela.caravelli@ircc.it
Ubicaciones de estudio
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Candiolo, Italia, 10060
- Reclutamiento
- Fondazione del Piemonte per l'Oncologia
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Contacto:
- Luisa Gioeni, PharmD
- Número de teléfono: 3959 +39011993
- Correo electrónico: luisa.gioeni@ircc.it
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Sub-Investigador:
- Fabrizio Carnevale Schianca, MD
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Sub-Investigador:
- Daniela Caravelli, MD
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Sub-Investigador:
- Dario Sangiolo, MD
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Sub-Investigador:
- Susanna Gallo, MD
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Sub-Investigador:
- Valentina Coha, MD
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Sub-Investigador:
- Giovanni Grignani, MD
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Sub-Investigador:
- Delia Rota Scalabrini, MD
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Sub-Investigador:
- Marco Fizzotti, MD
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Torino, Italia, 10126
- Aún no reclutando
- Ospedale Regina Margherita
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Contacto:
- Massimo Berger, MD
- Número de teléfono: 5360 +39011.313
- Correo electrónico: massimoberger@gmail.com
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Investigador principal:
- Franca Fagioli, MD
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Sub-Investigador:
- Elena Vassallo, MD
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Sub-Investigador:
- Massimo Berger, MD
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Sub-Investigador:
- Francesca Nesi, MD
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Sub-Investigador:
- Paola Quarello, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Patient is scheduled for transplant of 'mobilized' peripheral blood stem cells (PBSC) from a genotypically HLA-unrelated or related identical or partially mismatched stem cell donor.
- Patient is ≥ 18 years and ≤ 65 years of age.
Diagnosis of malignancy. Patients will be divided on the basis of their disease in low risk and high risk patients.
High risk diseases: AML > CR1, ALL > CR1, CML in CP #2, AP or BP, non-Hodgkin's lymphoma > CR2, Hodgkin's lymphoma > CR2, other patient with refractory malignancy Low risk: multiple myeloma (all patients), AML in CR1, myelodysplastic syndrome beyond RA (including CMML) and ALL in CR1.
- Patient or legal guardian has signed/dated the informed consent form.
- Female patients must have a negative pregnancy test (blood or urine) unless they are prepuberal or surgically sterile.
- Estimated Creatinine Clearance ≥ 60 mL/min at time of consent.
- Total bilirubin is ≤ 1.5 times the upper limit of normal at time of consent.
- SGOT and SGPT are ≤ 2.0 times the upper limit of normal at time of consent.
Exclusion Criteria:
- Patient > 65 years of age
- Patient has not signed/dated the informed consent form.
- Patient is receiving a T-cell depleted hematopoietic stem cell graft.
- Pregnant or lactating women
- Patient has an acute pulmonary infection suspected on the basis of abnormal chest x-ray.
- Patient has an active systemic infection not controlled with anti-microbial therapy.
- Patient is a known carrier of any of the Human Immune Deficiency Viruses (HIV-1 or others).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Solo caso
- Perspectivas temporales: Otro
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Incidence of the observed GVHD rate and infections
Periodo de tiempo: 100 day
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Evaluations through day 100 after transplantation will be performed with:
Tacrolimus whole blood concentrations weekly starting on day 6. CMV surveillance, Aspergillus surveillance will be performed per standard practice guidelines at the performance site. Evaluations after 100 days post-transplant will be completed per standard practice guidelines at each performance site. |
100 day
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Overall survival
Periodo de tiempo: 1 years
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To determine the overall survival at 1 years (OS)
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1 years
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Progression-free survival
Periodo de tiempo: 1 years
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To determine progression-free survival at 1 years (PFS)
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1 years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Massimo Aglietta, md, Fondazione del Piemonte per l'Oncologia
- Silla de estudio: Franca Fagioli, MD, Ospedale Regina Margherita
- Silla de estudio: Fabrizio Carnevale-Schianca, MD, Fondazione del Piemonte per l'Oncologia
Publicaciones y enlaces útiles
Publicaciones Generales
- Carnevale-Schianca F, Caravelli D, Gallo S, Becco P, Paruzzo L, Poletto S, Polo A, Mangioni M, Salierno M, Berger M, Pessolano R, Saglio F, Gottardi D, Rota-Scalabrini D, Grignani G, Fizzotti M, Ferrero I, Frascione PMM, D'Ambrosio L, Gaidano V, Gammaitoni L, Sangiolo D, Saglietto A, Vassallo E, Cignetti A, Aglietta M, Fagioli F. Post-Transplant Cyclophosphamide and Tacrolimus-Mycophenolate Mofetil Combination Governs GVHD and Immunosuppression Need, Reducing Late Toxicities in Allogeneic Peripheral Blood Hematopoietic Cell Transplantation from HLA-Matched Donors. J Clin Med. 2021 Mar 11;10(6):1173. doi: 10.3390/jcm10061173.
- Carnevale-Schianca F, Caravelli D, Gallo S, Coha V, D'Ambrosio L, Vassallo E, Fizzotti M, Nesi F, Gioeni L, Berger M, Polo A, Gammaitoni L, Becco P, Giraudo L, Mangioni M, Sangiolo D, Grignani G, Rota-Scalabrini D, Sottile A, Fagioli F, Aglietta M. Post-Transplant Cyclophosphamide and Tacrolimus-Mycophenolate Mofetil Combination Prevents Graft-versus-Host Disease in Allogeneic Peripheral Blood Hematopoietic Cell Transplantation from HLA-Matched Donors. Biol Blood Marrow Transplant. 2017 Mar;23(3):459-466. doi: 10.1016/j.bbmt.2016.12.636. Epub 2016 Dec 27.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HDCTX 2013
Información sobre medicamentos y dispositivos, documentos del estudio
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