Status:
COMPLETED
Trial to Assess the Efficacy of a TCR Alfa Beta Depleted Graft in Pediatric Affected by ALL or AML and Receiving an HSCT
Lead Sponsor:
Mariella Enoc
Conditions:
Acute Lymphoblastic Leukemia
Leukemia Acute Myeloid - AML
Eligibility:
All Genders
3-20 years
Phase:
PHASE1
PHASE2
Brief Summary
Allocation: Non-Randomized Endpoint Classification: Safety/Feasibility Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment Study to assess the feasibility and sa...
Detailed Description
In this study the hypothesis is that the transplantation of Peripheral blood stem cells (PBSC)selectively depleted of TCR alfa beta T lymphocytes would offers some advantages over the use of positivel...
Eligibility Criteria
Inclusion
- Patients aged ≥ 3 months and \< 21 years
- Patients diagnosed with malignant hemopathies (Acute Lymphoblastic leukemia (ALL), Acute Myeloid Leukemia (AML), Non-Hodgkin Lymphoma (NHL)) in complete morphological remission or Myelodysplastic Syndromes (MDS), Solid Tumors or non malignant hematological disorders (SCID, Acquired and Congenital Aplastic Anemia, other Primary Immunodeficiencies, Life-threatening Cytopenia) eligible for an allogeneic transplantation and lacking a related or unrelated HLA-matched donor
- Patients displaying an HLA-partially matched family donor
- Lansky/Karnofsky score \> 40, WHO \> 4
- Signed written informed consent
Exclusion
- Grade \>II acute GvHD or chronic extensive GvHD at the time of inclusion
- Patient receiving an immunosuppressive treatment for GvHD treatment at the time of inclusion
- Dysfunction of liver (ALT/AST \> 5 times normal value, or bilirubin \> 3 times normal value), or of renal function (creatinine clearance \< 30 ml / min)
- Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or left ventricular ejection fraction \<40%)
- Current active infectious disease (including positive HIV serology or viral RNA)
- Serious concurrent uncontrolled medical disorder
- Pregnant or breast feeding female patient
- Lack of parents' informed consent.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01810120
Start Date
January 1 2012
End Date
December 1 2016
Last Update
January 23 2017
Active Locations (1)
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1
Department of Oncology/Hematology of the Hospital Bambino Gesù (Roma)
Rome, Italy, Italy, 00165