Transplantation of Ex-vivo Expanded Cord Blood Stems Cells (GRAPA)
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- The number of granulocytes, which will be evaluated daily after transplantation. And chimerism to be measured on the cells (total nucleated cells and lymphocytes) from peripheral blood on days 15, 42, 60, 100, 180, 360. [ Time Frame: Daily for Blood évaluation and on days 15-42-60-100-180-360 for chimérisme évaluation. ] [ Designated as safety issue: Yes ]
- feasibility of expansion [ Time Frame: during and after expansion ] [ Designated as safety issue: No ]
- Immediate tolerance of a graft amplified injection. Determined by measurement of vital parameters during injection of the graft and within 3 hours of observation and clinical tolerance. [ Time Frame: during injection of the graft and within 3 hours of observation ] [ Designated as safety issue: Yes ]
- The payback of a platelet count> 20 000/microlitre bloodless. Measured by the blood count and platelet daily during hospitalization and at least 2 times a week. [ Time Frame: until the payback of the platelet count : measured daily during hospitalization and at least 2 times a week after ] [ Designated as safety issue: Yes ]
- The length of hospitalization since the beginning of conditioning until the first exit for more than 2 days. [ Time Frame: lenght of hospitalization since the beginning of conditioning ] [ Designated as safety issue: No ]
- The number of transfusions of red blood cells and platelets during the 1st hospitalization [ Time Frame: during the first hospitalization ] [ Designated as safety issue: No ]
- The incidence of graft loss or rejection within 6 months after transplantation, defined as the installation of a central cytopenia with loss of chimerism [ Time Frame: Within 6 months after transplantation ] [ Designated as safety issue: Yes ]
- The incidence of acute and chronic GVHD,determined by clinical examination Biopsies of target organs(skin, intestine, liver) will be conducted to confirm the diagnosis if possible. [ Time Frame: daily during hospitalization and at least twice weekly until D 100 after transplantation and then weekly or bi-monthly until one year post transplant. ] [ Designated as safety issue: Yes ]
- The mortality rate for transplantation in the year following the transplant, [ Time Frame: in the year following the transplant ] [ Designated as safety issue: Yes ]
- The incidence of relapse of hematologic malignancies, [ Time Frame: in the year following the transplant ] [ Designated as safety issue: Yes ]
- survival and disease-free survival in the year following the transplant [ Time Frame: in the year following the transplant ] [ Designated as safety issue: Yes ]
- Monitoring of immune reconstitution. This reconstruction will be followed by determining the rate of immunoglobulin G, M and A and the number of T lymphocytes CD3 +, CD4 + and CD8 + (assessments on days 15, 42, 60, 100, 180, 360). [ Time Frame: on days 15, 42, 60, 100, 180, 360 ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2010|
|Study Completion Date:||September 2014|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Other: allogeneic transplant
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01034449
|Service d'hématologie et d'Oncologie Clinique - Hôpital Lapeyronie - 371 avenue du Doyen Gaston GIRAUD|
|Montpellier, France, 34295|
|Service d'Hématologie, Hôpital Hôtel Dieu, CHU de Nantes - 1 Place Alexis Ricordeau|
|Nantes, France, 44093|
|Service des maladies du sang - Hôpital Haut-Lévêque - avenue de Magellan|
|Pessac, France, 33600|
|Principal Investigator:||Noel MILPIED, MD||University Hospital Bordeaux, France|