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
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|ClinicalTrials.gov Identifier: NCT02300571|
Recruitment Status : Unknown
Verified August 2017 by Fondazione del Piemonte per l'Oncologia.
Recruitment status was: Recruiting
First Posted : November 25, 2014
Last Update Posted : September 5, 2017
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||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|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||January 2018|
- Incidence of the observed GVHD rate and infections [ Time Frame: 100 day ]
Evaluations through day 100 after transplantation will be performed with:
- Complete blood count (CBC), including differential and platelet count per standard practice guidelines at the performance site.
- Blood chemistries: including sodium, potassium, chloride, bicarbonate (HCO3) or total carbon dioxide (CO2), glucose, blood urea nitrogen (BUN), creatinine, calcium, magnesium, phosphorus, total bilirubin, total protein, albumin, serum glutamic oxaloacetic transaminase (SGOT), lactic dehydrogenase (LDH), alkaline phosphatase per standard practice guidelines at the performance site.
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.
- Overall survival [ Time Frame: 1 years ]To determine the overall survival at 1 years (OS)
- Progression-free survival [ Time Frame: 1 years ]To determine progression-free survival at 1 years (PFS)
Biospecimen Retention: Samples With DNA
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): NCT02300571
|Contact: Fabrizio Carnevale-Schianca, MD||+39011993 ext firstname.lastname@example.org|
|Contact: Daniela Caravelli, MD||+39011993 ext email@example.com|
|Fondazione del Piemonte per l'Oncologia||Recruiting|
|Candiolo, Italy, 10060|
|Contact: Luisa Gioeni, PharmD +39011993 ext 3959 firstname.lastname@example.org|
|Sub-Investigator: Fabrizio Carnevale Schianca, MD|
|Sub-Investigator: Daniela Caravelli, MD|
|Sub-Investigator: Dario Sangiolo, MD|
|Sub-Investigator: Susanna Gallo, MD|
|Sub-Investigator: Valentina Coha, MD|
|Sub-Investigator: Giovanni Grignani, MD|
|Sub-Investigator: Delia Rota Scalabrini, MD|
|Sub-Investigator: Marco Fizzotti, MD|
|Ospedale Regina Margherita||Not yet recruiting|
|Torino, Italy, 10126|
|Contact: Massimo Berger, MD +39011.313 ext 5360 email@example.com|
|Principal Investigator: Franca Fagioli, MD|
|Sub-Investigator: Elena Vassallo, MD|
|Sub-Investigator: Massimo Berger, MD|
|Sub-Investigator: Francesca Nesi, MD|
|Sub-Investigator: Paola Quarello, MD|
|Principal Investigator:||Massimo Aglietta, MD||Fondazione del Piemonte per l'Oncologia|
|Study Chair:||Franca Fagioli, MD||Ospedale Regina Margherita|
|Study Chair:||Fabrizio Carnevale-Schianca, MD||Fondazione del Piemonte per l'Oncologia|