A Study Comparing Single Versus Double Umbilical Cord Blood Transplantation in the Young With Acute Leukemia Remission
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Purpose
Unrelated cord blood transplantation (UCBT) has been used for several years when there is no HLA identical sibling or unrelated donor.Since the recent publication of encouraging results after transplantation of two UCB units, the number of these double-transplantations increases in a very significant way.However, there is currently no prospective study comparing in a reliable way the double-transplantation to single-transplantation results.The investigators propose a prospective and randomized study comparing the results of single versus double unit UCBT in children and young adults (< 35 yrs) with acute leukemia in remission. This is an open, multicenter study carried out in the allogeneic transplant centers from the French society for hematopoietic stem cell transplantation and cell therapy. The primary objective is to compare the incidence of transplantation failure in the two treatment arms. Transplantation failure, the primary endpoint of the study, is defined by the occurrence of one of the following events : transplant-related death, second allogeneic transplantation or autologous backup infusion for primary engraftment failure, autologous recovery. The financial impact of these double-transplantations being to date unknown, the project also includes a cost-effectiveness study, the effectiveness criterion being a decrease in transplantation failure incidence. The secondary clinical endpoints are: overall survival and disease-free survival, relapse incidence, transplant-related mortality, incidence of severe infections and GvHD. The secondary biological endpoints are: hematological and immunological recovery, post transplant chimerism.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Procedure: Transplantation of unrelated cord blood unit(s) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective, Multicenter Randomized Study Comparing Single Versus Double Umbilical Cord Blood Transplantation in Children and Young Adults (<35 Years) With Acute Leukemia Remission |
- to compare the incidence of transplantation failure in the two treatment arms. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- a cost-effectiveness study, the effectiveness criterion being a decrease in transplantation failure incidence. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 198 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Double unit unrelated cord blood transplantation
Transplantation of unrelated cord blood units is done at least 24 hours after last chemotherapy and carried out during the same day. The unit presenting the best degree of HLA compatibility with the patient will be transfused in first. If the 2 units have the same degree of HLA compatibility with the recipient, the unit with the higher cell dose will be transfused in first. A 2 hours time interval between the 2 transfusions will be respected.
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Procedure: Transplantation of unrelated cord blood unit(s)
Myeloablative conditioning regimen includes, according to the patient age, either total body irradiation, fludarabine and cyclophosphamide with a GvHD prophylaxis based on cyclosporine A and mycophenolate, or the association busulfan, cyclophosphamide and anti-thymocyte globulin with GvHD prophylaxis being cyclosporine A and steroids.
Other Name: Infusion of unrelated cord blood unit(s)
|
|
Active Comparator: single unit unrelated cord blood transplantation
Transplantation of a single unrelated cord blood unit at least 24 hours after last chemotherapy
|
Procedure: Transplantation of unrelated cord blood unit(s)
Myeloablative conditioning regimen includes, according to the patient age, either total body irradiation, fludarabine and cyclophosphamide with a GvHD prophylaxis based on cyclosporine A and mycophenolate, or the association busulfan, cyclophosphamide and anti-thymocyte globulin with GvHD prophylaxis being cyclosporine A and steroids.
Other Name: Infusion of unrelated cord blood unit(s)
|
Show Detailed Description Eligibility| Ages Eligible for Study: | up to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- age < 35 years
- acute leukemia in remission which need unrelated transplantation
- lack of a suitable unrelated donor
- availability of at least 2 UCB units 4/6, 5.6 or 6/6 HLA identical to the patient and between them, which contain more than 3 x 107 nucleated cells per kilogram of recipient for the first unit and more than de 1.5 x 107 nucleated cells per kilogram of recipient for the second
- general status compatible with a myéloablative conditioning regimen
Exclusion Criteria:
- availability of an HLA identical sibling
- availability of an unrelated donor considered to be acceptable by the transplant center
- History of allogeneic stem cell transplantation
- History of a total body irradiation
- Organ failure or patient general status considered to be incompatible with a myeloablative conditioning regimen
- Active psychiatric disease
- Uncontrolled bacterial, viral or fungal infection
- Positive HIV serology
- Pregnancy
Contacts and Locations| Contact: Gerard MICHEL | gerard.michel@ap-hm.fr |
| France | |
| Assistance Publique - Hôpitaux de Marseille | Recruiting |
| Marseille, France | |
| Contact: Gerard MICHEL gerard.michel@ap-hm.fr | |
| Principal Investigator: | Gerard MICHEL | Assistance Publique - Hôpitaux de Marseille |
More Information
No publications provided
| Responsible Party: | Assistance Publique - Hôpitaux de Marseille, Direction de la recherche clinique et de l'innovation |
| ClinicalTrials.gov Identifier: | NCT01067300 History of Changes |
| Other Study ID Numbers: | 2009-17, 2009-A00792-55 |
| Study First Received: | February 10, 2010 |
| Last Updated: | May 18, 2010 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Assistance Publique Hopitaux De Marseille:
|
young acute leukemia in remission Children or young adults (< 35 years) with acute leukemia in remission |
Additional relevant MeSH terms:
|
Leukemia Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on May 16, 2013