Status:
UNKNOWN
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
Lead Sponsor:
Fondazione del Piemonte per l'Oncologia
Conditions:
Hematological Malignancies
Eligibility:
All Genders
18-65 years
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.
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 exer...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2018
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02300571
Start Date
September 1 2013
End Date
January 1 2018
Last Update
September 5 2017
Active Locations (2)
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1
Fondazione del Piemonte per l'Oncologia
Candiolo, Italy, 10060
2
Ospedale Regina Margherita
Torino, Italy, 10126