Hematological Malignancies Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | January 2018 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione del Piemonte per l'Oncologia | Candiolo | |
Italy | Ospedale Regina Margherita | Torino |
Lead Sponsor | Collaborator |
---|---|
Fondazione del Piemonte per l'Oncologia |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of the observed GVHD rate and infections | 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. |
100 day | |
Secondary | Overall survival | To determine the overall survival at 1 years (OS) | 1 years | |
Secondary | Progression-free survival | To determine progression-free survival at 1 years (PFS) | 1 years |
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