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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
Sponsor:
Information provided by (Responsible Party):
Fondazione del Piemonte per l'Oncologia

Brief Summary:
This observational study is proposed to observe the effect of high-dose, post-transplantation cyclophosphamide after a T cell-replete, HLA-matched PBSC graft from an HLA-identical or mismatched donor.

Condition or disease
Hematological Malignancies

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Other
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





Primary Outcome Measures :
  1. Incidence of the observed GVHD rate and infections [ Time Frame: 100 day ]

    Evaluations through day 100 after transplantation will be performed with:

    1. Complete blood count (CBC), including differential and platelet count per standard practice guidelines at the performance site.
    2. 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.



Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 1 years ]
    To determine the overall survival at 1 years (OS)

  2. Progression-free survival [ Time Frame: 1 years ]
    To determine progression-free survival at 1 years (PFS)


Biospecimen Retention:   Samples With DNA
PBMC


Information from the National Library of Medicine

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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
Patients with Hematological Malignancies Eligible to Allogeneic Hematopoietic Stem Cell Transplant using Peripheral Blood Stem Cells (PBSC) from unrelated or related, HLA-identical or partially mismatched donors
Criteria

Inclusion Criteria:

  1. 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.
  2. Patient is ≥ 18 years and ≤ 65 years of age.
  3. 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.

  4. Patient or legal guardian has signed/dated the informed consent form.
  5. Female patients must have a negative pregnancy test (blood or urine) unless they are prepuberal or surgically sterile.
  6. Estimated Creatinine Clearance ≥ 60 mL/min at time of consent.
  7. Total bilirubin is ≤ 1.5 times the upper limit of normal at time of consent.
  8. SGOT and SGPT are ≤ 2.0 times the upper limit of normal at time of consent.

Exclusion Criteria:

  1. Patient > 65 years of age
  2. Patient has not signed/dated the informed consent form.
  3. Patient is receiving a T-cell depleted hematopoietic stem cell graft.
  4. Pregnant or lactating women
  5. Patient has an acute pulmonary infection suspected on the basis of abnormal chest x-ray.
  6. Patient has an active systemic infection not controlled with anti-microbial therapy.
  7. Patient is a known carrier of any of the Human Immune Deficiency Viruses (HIV-1 or others).

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): NCT02300571


Contacts
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Contact: Fabrizio Carnevale-Schianca, MD +39011993 ext 3623 fabrizio.carnevale@ircc.it
Contact: Daniela Caravelli, MD +39011993 ext 3623 daniela.caravelli@ircc.it

Locations
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Italy
Fondazione del Piemonte per l'Oncologia Recruiting
Candiolo, Italy, 10060
Contact: Luisa Gioeni, PharmD    +39011993 ext 3959    luisa.gioeni@ircc.it   
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    massimoberger@gmail.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         
Sponsors and Collaborators
Fondazione del Piemonte per l'Oncologia
Investigators
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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fondazione del Piemonte per l'Oncologia
ClinicalTrials.gov Identifier: NCT02300571     History of Changes
Other Study ID Numbers: HDCTX 2013
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases
Cyclophosphamide
Tacrolimus
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Calcineurin Inhibitors
Enzyme Inhibitors
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents