A Study Comparing Single Versus Double Umbilical Cord Blood Transplantation in the Young With Acute Leukemia Remission

NCT01067300 | Unknown Phase 3

• 2 other identifiers: 2009-172009-A00792-55
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Leukemia

Keywords

young; acute leukemia in remission; Children or young adults (< 35 years) with acute leukemia in remission

Outcome Measures

Primary Outcomes (1)

• to compare the incidence of transplantation failure in the two treatment arms.

  3 years

Secondary Outcomes (1)

• a cost-effectiveness study, the effectiveness criterion being a decrease in transplantation failure incidence.

  3 years

Study Arms (2)

Double unit unrelated cord blood transplantation

ACTIVE COMPARATOR

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.

Procedure: Transplantation of unrelated cord blood unit(s)

single unit unrelated cord blood transplantation

ACTIVE COMPARATOR

Transplantation of a single unrelated cord blood unit at least 24 hours after last chemotherapy

Procedure: Transplantation of unrelated cord blood unit(s)

Interventions

Transplantation of unrelated cord blood unit(s) PROCEDURE

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.

Also known as: Infusion of unrelated cord blood unit(s)

Double unit unrelated cord blood transplantation; single unit unrelated cord blood transplantation

Eligibility Criteria

• Age: Up to 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique - Hôpitaux de Marseille

Marseille, France

Location

Related Publications (1)

• Michel G, Galambrun C, Sirvent A, Pochon C, Bruno B, Jubert C, Loundou A, Yakoub-Agha I, Milpied N, Lutz P, Marie-Cardine A, Gandemer V, Blaise D, Michallet M, Rialland F, Renard C, Oudin C, Esmiol S, Seux M, Baumstarck K, Mohty M, Rocha V, Dalle JH. Single- vs double-unit cord blood transplantation for children and young adults with acute leukemia or myelodysplastic syndrome. Blood. 2016 Jun 30;127(26):3450-7. doi: 10.1182/blood-2016-01-694349. Epub 2016 Apr 20.

  PMID: 27099151 DERIVED

MeSH Terms

Conditions

Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Gerard MICHEL

  Assistance Publique - Hôpitaux de Marseille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2010
• First Posted: February 11, 2010
• Study Start: February 1, 2010
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: October 1, 2015

Record last verified: 2015-09

Locations

FR (1)