Intra-bone Cord Blood Transplantation in Patients With Haematological Malignancies

Phase 1

• Conditions: High Risk Haematological Malignancies; Advanced Haematological Malignancies
• Interventions: Procedure: Intrabone Allogeneic Transplant

• Registration Number: NCT01613066
• Lead Sponsor: Ospedale Santa Croce-Carle Cuneo

Brief Summary

Cord blood (CB) from an unrelated donor is increasingly used an alternative source of hematopoietic stem cells for adults with hematologic malignancies who lack an HLA-matched donor. However, the utilization of single-unit CB for transplantation of adult patients has been impeded by the low number of nucleated cells available from individual CB units. Direct intrabone CB injection (IBCBi) has been recently investigated as a solution to cell dose problem in adults, with the aims of minimizing non-specific loss of progenitors. We set up a phase I-II study to assess the safety and efficacy of CB transplantation by IBCBi in adult patients with advanced or high-risk hematological malignancies

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Status Verified: 2012-06
• Study First Submitted: 2012-06-04
• Study First Submitted QC: 2012-06-05
• Last Update Submitted: 2012-06-05
• Study First Posted: 2012-06-06
• Last Update Posted: 2012-06-06
• Primary Completion: 2012-11
• Study Completion: 2013-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Advanced or High Risk Haematological Malignancies
• Age 18-65 years
• no suitable unrelated HLA-matched donors identified in a clinically useful time-frame
• Informed consent

Exclusion Criteria

• Active infectious disease at inclusion
• HIV- positivity or active hepatitis infection
• Impaired liver function (Bilirubin > upper normal limit; Transaminases > 3.0 x upper normal limit) at inclusion
• Impaired renal function (Creatinine-clearance <60 ml/min; Serum Creatinine >1.5 x upper normal limit) at inclusion
• Psychiatric diseases or conditions that might impair the ability to give informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Intrabone Allogeneic Transplant	Patients with high risk haematological malignancies

Primary Outcome Measures

Name	Time	Method
Time to neutrophil recovery	28 days after transplantation

Secondary Outcome Measures

Name	Time	Method
Acute graft versus host disease	100 days after transplantation
Overall Survival	One year after transplantation
Incidence of platelet engraftment	100 days after transplantation
Chronic Graft Versus Host Disease	One year after transplantation

Trial Locations

Locations (1)

Azienda Ospedaliera S Croce e Carle; 🇮🇹 Cuneo, Italy