Adoptive Immunotherapy With CD25/71 Allodepleted Donor T Cells to Improve Immunity After Unrelated Donor Stem Cell Transplant
Phase 1/Phase 2
16 Years
N/A
16 Years
N/A
Not Enrolling
Both
Acute Myeloid Leukaemia, Acute Lymphoblastic Leukaemia
Both
Acute Myeloid Leukaemia, Acute Lymphoblastic Leukaemia
Trial Information
Adoptive Immunotherapy With CD25/71 Allodepleted Donor T Cells to Improve Immunity After Unrelated Donor Stem Cell Transplant
Inclusion Criteria:
- Age ≥16 years
- Underlying acute myeloid or acute lymphoblastic leukaemia
- Planned allogeneic peripheral blood stem cell transplantation from a 10/10 or 9/10
HLA matched unrelated donor, using an Alemtuzumab-based conditioning protocol
- Written Informed consent
Exclusion Criteria:
- Life expectancy < 6 weeks
- Female patients who are pregnant and lactating
- Patients who are serologically positive for Hepatitis B, C or HIV pre-SCT
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Circulating CD3+ve T cell count at 4 months post-SCT
Outcome Time Frame:
4 months post transplant
Safety Issue:
No
Principal Investigator
Persis Amrolia
Investigator Role:
Study Chair
Investigator Affiliation:
Great Ormond Street Hospital for Children NHS Foundation Trust
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
UCL/11/0519
NCT ID:
NCT01827579
Start Date:
January 2014
Completion Date:
January 2018
Related Keywords:
- Acute Myeloid Leukaemia
- Acute Lymphoblastic Leukaemia
- Transplant
- CD25/71 allodepleted donor T cells
- Infection
- Acute Myeloid Leukaemia
- Acute Lymphoblastic Leukaemia
- Adult
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
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