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
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiekontakt
- Navn: Fabrizio Carnevale-Schianca, MD
- Telefonnummer: 3623 +39011993
- E-post: fabrizio.carnevale@ircc.it
Studer Kontakt Backup
- Navn: Daniela Caravelli, MD
- Telefonnummer: 3623 +39011993
- E-post: daniela.caravelli@ircc.it
Studiesteder
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Candiolo, Italia, 10060
- Rekruttering
- Fondazione del Piemonte per l'Oncologia
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Ta kontakt med:
- Luisa Gioeni, PharmD
- Telefonnummer: 3959 +39011993
- E-post: luisa.gioeni@ircc.it
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Underetterforsker:
- Fabrizio Carnevale Schianca, MD
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Underetterforsker:
- Daniela Caravelli, MD
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Underetterforsker:
- Dario Sangiolo, MD
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Underetterforsker:
- Susanna Gallo, MD
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Underetterforsker:
- Valentina Coha, MD
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Underetterforsker:
- Giovanni Grignani, MD
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Underetterforsker:
- Delia Rota Scalabrini, MD
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Underetterforsker:
- Marco Fizzotti, MD
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Torino, Italia, 10126
- Har ikke rekruttert ennå
- Ospedale Regina Margherita
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Ta kontakt med:
- Massimo Berger, MD
- Telefonnummer: 5360 +39011.313
- E-post: massimoberger@gmail.com
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Hovedetterforsker:
- Franca Fagioli, MD
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Underetterforsker:
- Elena Vassallo, MD
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Underetterforsker:
- Massimo Berger, MD
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Underetterforsker:
- Francesca Nesi, MD
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Underetterforsker:
- Paola Quarello, MD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Bare etui
- Tidsperspektiver: Annen
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Incidence of the observed GVHD rate and infections
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Overall survival
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Massimo Aglietta, md, Fondazione del Piemonte per l'Oncologia
- Studiestol: Franca Fagioli, MD, Ospedale Regina Margherita
- Studiestol: Fabrizio Carnevale-Schianca, MD, Fondazione del Piemonte per l'Oncologia
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
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