Malignant Haematological Disease Clinical Trial
Official title:
Transplantation of Ex-vivo Expanded Human Cord Blood Hematopoietic Stem Cells Expanded: Evaluation of Hematopoietic and Immunologic Reconstitution After a Reduced-intensity Conditioning Regimen
This program offers the opportunity to receive an allogeneic transplant to try to control
the malignant hematologic in the absence of acceptable conventional donor and with a
risk-benefit ratio equivalent to that which would be expected with a transplant from a more
conventional donor.
An economy of means in that this method could serve as an alternative to 2 units of
placental blood transplantation. The current cost of disposal of a unit of placental blood
from a bank is approximately 22000 € (Source: Biomedicine Agency, 2007 rates). The
amplification process as controlled by "EFSAL" is 12000 €. Therefore, buying a unit and
ex-vivo amplification is more economical. Moreover, the availability of placental blood is
not infinite, and the use of one unit per patient will also save resources that can be
valuable for certain groups of patients.
In the longer term, methods of amplification of specific immunocompetent cells (from the
fraction of CD 34 neg cells) are already being evaluated in the laboratory. They allow to
consider a faster recovery, better and more targeted, including cells against the disease
for which transplantation is performed.
This is a multicenter prospective non randomized phase 2 clinical trial.
The primary objective is defined by getting a neutrophil count above 500/ml for 3
consecutive days at day 42 after transplantation, in association with complete or partial
chimerism on T cells (10 % to 90%).
The secondary objectives are:
- the feasibility of expansion,
- tolerance immediate injection of a graft amplified,
- the payback of a platelet count> 20 000/microlitre without transfusion,
- Incidence of graft loss or rejection within 6 months following transplantation,
- the incidence of acute and chronic GVHD,
- the mortality rate associated with transplantation,
- the incidence of relapse of hematologic malignancies,
- Overall survival,
- Disease-free survival at 1 year post transplant.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment