Intra-bone Cord Blood Transplantation in Patients With Ha... | NCT01613066

Studies
Intra-bone Cord Blood Transplantation in Patients With Haematological Malignancies

NCT01613066

Sponsor

Ospedale Santa Croce-Carle Cuneo

Status

Unknown status

Last Update Posted

Jun 6, 2012Estimated

Enrollment

15Estimated

Phase

Phase 1Phase 2

Conditions

High Risk Haematological Malignancies
Advanced Haematological Malignancies

Interventions

Intrabone Allogeneic Transplant

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Nov 2012Estimated

Completion Date

May 2013Estimated

First Submitted Date

Jun 4, 2012

First Submission Date that Met QC Criteria

Jun 5, 2012

First Posted Date

Jun 6, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2012

Last Update Posted Date

Jun 6, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Experimental	Patients with high risk haematological malignancies	Procedure: Intrabone Allogeneic Transplant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intrabone Allogeneic Transplant	Procedure	Unrelated single unit intrabone cord blood transplantation	Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to neutrophil recovery		28 days after transplantation

Secondary Outcomes

Measure	Description	Time Frame
Incidence of platelet engraftment		100 days after transplantation
Acute graft versus host disease		100 days after transplantation
Chronic Graft Versus Host Disease

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Roberto Sorasio, Head, MD	Contact	+390171642229		rsorasio@inwind.it
Daniele Mattei, MD	Contact	+390171642229		mattei.d@ospedale.cuneo.it

Overall Officials

Name	Affiliation	Role
Daniele Mattei, MD	ASO S Croce e Carle	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Azienda Ospedaliera S Croce e Carle	Recruiting	Cuneo	Cuneo	12100	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18693069	Background	Frassoni F, Gualandi F, Podesta M, Raiola AM, Ibatici A, Piaggio G, Sessarego M, Sessarego N, Gobbi M, Sacchi N, Labopin M, Bacigalupo A. Direct intrabone transplant of unrelated cord-blood cells in acute leukaemia: a phase I/II study. Lancet Oncol. 2008 Sep;9(9):831-9. doi: 10.1016/S1470-2045(08)70180-3. Epub 2008 Aug 8.
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