The purpose of this study is to evaluate the safety and the feasibility, and the success of engraftment of the introduction of Cal-1 gene-transduced haematopoietic cell populations (Ttn and HSPCtn) in patients with HIV-1-related high-risk lymphoma.
not provided
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Autologous CD34+ Haematopoietic Stem/Progenitor Cells and CD4+ T Lymphocytes Transduced with LVsh5/C46, a Dual Anti-HIV Gene Transfer Construct
Hôpital Saint Louis
Paris, France
Incidence of adverse event post transplant
to evaluate the procedure safety
Time frame: 24 months post-transplant
Success of hematopoietic stem cell engraftment
evaluation of Cal-1 marking and expression in peripheral blood subpopulations (monocytes, CD4+ and CD8+ lymphocytes)
Time frame: 24 months post-transplant
Overall survival
Time frame: 24 months post-transplant
Absence of detection of vector-derived Replication competent lentivirus (RCL)
Time frame: 24 months post-transplant
Frequency and severity of clinical adverse events
as assessed by the United States national Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Time frame: 24 months post-transplant
Absence of tropism shift from R5 to dual/mixed or X4 at any point after Day 0
Time frame: 24 months post-transplant
Quantify gene transfer efficiency and expression
extent of HSPCtn and Ttn survival as measured by Cal-1 marking and expression in peripheral blood
Time frame: 24 months post-transplant
Time to restart antiretroviral therapy
Time frame: 24 months post-transplant
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