Hematological Malignancies Clinical Trial
Official title:
Allogenic Transplantation of Ex-vivo Expanded CB Progenitors for Haematological Disorders
The aim of this study is to evaluate the safety profile and tolerability of infusion of cord blood cells expanded in the lab and to evaluated whether through the infusion of expanded cells it is possible to expedite engraftment time after transplantation.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 2015 |
Est. primary completion date | November 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - age > 18 years - hematological malignancy - standard indication for allogeneic transplantation - expected survival time over 12 weeks - no related or unrelated donor - availability of a cord blood unit of compatible placental blood cryopreserved in at least 2 different bags; one of the two units should have a cellular content at least equal to the minimum dose of 2 x 107 nucleated cells per kilogram of body weight Exclusion Criteria: - Eastern Cooperative Oncology Group (ECOG) performance status >2 - Prior allogeneic transplantation - Pregnant or nursing women - Positive serology for hepatitis B or C - HIV positive - Left ventricular ejection fraction < 50% - DLCO < 50% - Psychiatric, addictive, or any disorder/disease which compromises ability to give informed consent for participation in this study - Treatment with other investigational drugs within 4 weeks of enrolling in this protocol |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Dr. Avichai Shimoni MD | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety | Number of patients with adverse events during infusion | 1 month | Yes |
Primary | engraftment | Time to engraftment | 3 months | Yes |
Primary | treatment-related toxicity | Type and severity of adverse events after transplantation using the NCI CTC scale | 3 months | Yes |
Primary | GVHD | Number of patients with acute and chronic GVHD after transplantation | 1 year | Yes |
Secondary | Immunological reconstruction | immunological reconstruction after transplantation measured by lymphocyte number and function | 5 years | No |
Secondary | relapse | rate of disease recurrence | 5 years | No |
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