Intrabone Infusion of Cord Blood in Adults With Hematological Malignancies

NCT00886522 | Completed Phase 2

• 1 other identifier: 152/2008/U/Sper
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the engraftment of donor hemopoiesis (proportion of transplanted patients with successful engraftment at day +42) in adult patients affected by high risk hematological malignancies after intrabone infusion of cord blood.

Conditions

Hematological Malignancies

Keywords

Anti-thymocyte globulin Fresenius; Busulfan; Cord blood; Cyclophosphamide; Fludarabine; Human Leucocyte Antigen; Hematopoietic Stem Cell; Hematopoietic Stem Cell Transplant; Graft-versus-Host-Disease; Graft-versus-Host-Disease prophylaxis; Intrabone infusion; Thiotepa

Outcome Measures

Primary Outcomes (1)

• Proportion of transplanted patients with successful engraftment at day +42

  Within the first 42 days

Secondary Outcomes (5)

• Clinical response with the analysis of global survival, survival without relapse, relapse incidence

  1 year

• Acute and chronic GVHD incidence

  For acute GVHD 100 days; for chronic GVHD 1 year

• Infection incidence

  1 year

• Chimerism study on selected populations (myeloid, lymphoid, NK)

  30, 60, 100 days, 6 months and 1 year

• Studies on immunological reconstitution

  1 year

Study Arms (1)

Intrabone cord blood infusion

EXPERIMENTAL

All adults patients with hematological malignancies, lacking a HLA matched donor but with a HLA compatible CB unit, fulfilling the inclusion criteria, will undergo to intrabone HSC infusion of CB.

Procedure: Intrabone cord blood infusion

Interventions

Intrabone cord blood infusion PROCEDURE

Myeloablative conditioning regimen (MAC): i.v. Busulfan 12.8 mg/kg, Cyclophosphamide 120 mg/kg, ATG-Fresenius 30 mg/kg Reduced intensity conditioning regimen (RIC): Tiothepa 10 mg/kg, Fludarabine 100 mg/kg, Cyclophosphamide 100 mg/kg, ATG-Fresenius 30 mg/kg GVHD prophylaxis: Cyclosporine 1 mg/kg since day -7 to +120, Mycophenolate 15 mg kg x 2 since day +1 to +27

Intrabone cord blood infusion

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years.
• Patients affected by hematological malignancies without a HLA identical sibling donor or unrelated donor.
• Informed consent.

You may not qualify if:

• Patients with ECOG \< 2.
• Patients with blood creatine \> 2 mg/dl or with transaminase or cholestase index \> 5 times compared to normality upper limits.
• Patients with Cardiac Fraction Ejection \< 40%.
• Patients with DLCO \< 60% or Diffusing Lung Capacity of carbon monoxide attesting a severe pulmonary insufficiency.
• Patients with peripheral blast cell count over 10%.
• Second neoplasia diagnosed no more than 2 years before.
• Patients with active or suspected infection by fungi for which a therapeutic treatment is ongoing.
• HIV positive patients.
• HCV-RNA and HBV-RNA positive patients (it is possible to enrol them after discussion with the Principal Investigator).
• Pregnant or lactating women.
• Severe mental diseases.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

Hematology Institute "L. and A. Seràgnoli", S. Orsola-Malpighi University Hospital

Bologna, 40138, Italy

Location

Related Publications (52)

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Related Links

• The European Group for Blood and Marrow Transplantation
• Italian Group for Bone Marrow Transplantation and Cellular Therapy

MeSH Terms

Conditions

Hematologic Neoplasms; Graft vs Host Disease

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases

Study Officials

• Francesca Bonifazi, MD

  S. Orsola-Malpighi University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 22, 2009
• First Posted: April 23, 2009
• Study Start: April 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2013
• Last Updated: March 19, 2021

Record last verified: 2021-03

Locations

IT (1)