Status:
UNKNOWN
Transfer of Effector Memory T Cells (Tem) Following Allogeneic Stem Cell Transplantation
Lead Sponsor:
University College, London
Collaborating Sponsors:
Medical Research Council
Conditions:
Lymphoma
Leukemia
Eligibility:
All Genders
16-70 years
Phase:
PHASE1
Brief Summary
RATIONALE: Following stem cell transplantation, a major risk is graft-versus-host disease (GVHD). This occurs when donor immune cells that have been infused recognise the host's cells as 'foreign' and...
Detailed Description
Phase I study using a Bayesian Time-to-Event Continual Reassessment Method (CRM) to determine safety and maximum tolerated dose (MTD) of CD62L- Tem. Eligible patients and HLA-identical sibling donors...
Eligibility Criteria
Inclusion
- Patient Registration
- Severe aplastic anaemia or
- Primary immune deficiency or
- Haematological cancer which can be ONE OF the following:
- Non-Hodgkin's lymphoma (NHL) in CR or PR;
- Hodgkin's lymphoma (HL) in CR or PR;
- Chronic (Pro-)lymphocytic leukaemia (CLL or PLL) in CR or PR
- Plasma cell myeloma (PCM) in CR, VGPR or PR;
- Acute myeloid leukaemia (AML) in CR;
- Acute lymphoblastic leukaemia (ALL) in CR;
- Myelodysplastic syndrome (MDS) \< 10 % blasts in bone marrow;
- Chronic myelomonocytic leukaemia (CMML) \< 10% blasts in bone marrow
- Suitable for HLA-identical sibling transplant using a standard alemtuzumab-based conditioning regimen with calcineurin-inhibitor based immunoprophylaxis
- Aged ≥ 16 years, \<70 years
- Written informed consent
- Patient Registration
Exclusion
- Women who are pregnant or breast-feeding
- Life expectancy of \< 8 weeks
- Currently taking part in any other interventional clinical research study (involving any IMP, ATMP or cellular therapy)
- Proposed use of any other method of GVHD prophylaxis other than alemtuzumab and calcineurin inhibitor
- Organ dysfunction:
- LVEF\<45%
- Creatinine \>200 µmol/lglomerular filtration rate (corrected) \<50ml/min
- Bilirubin \> 50 µmol/l
- AST or ALT \>3x 2.5 x ULN (NB: If both are performed then both must be ≤3 2.5 x ULN)
- Patient Trial Treatment Exclusion criteria:
- Prior or active acute pattern GvHD of any grade
- Relapse or progression
- Primary or secondary graft failure
- Has received other cellular therapies
- Donor inclusion criteria:
- Aged ≥ 16 years
- HLA-identical sibling
- Have met transplant centre criteria regarding suitability for cell therapy donation
- Negative for HIV 1 and 2, hepatitis B, hepatitis C, HTLV-1 and 2, syphilis serology (to be confirmed before both registration and before trial treatmentat time of or up to 7 days following donation)
- Written informed consent
- Donor exclusion criteria:
- \- Pregnant/lactating women
Key Trial Info
Start Date :
October 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2023
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03836690
Start Date
October 21 2019
End Date
April 1 2023
Last Update
October 25 2019
Active Locations (1)
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1
UCLH
London, United Kingdom