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Intra-bone Cord Blood Transplantation in Patients With Haematological Malignancies


Phase 1/Phase 2
18 Years
65 Years
Open (Enrolling)
Both
High Risk Haematological Malignancies, Advanced Haematological Malignancies

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Trial Information

Intra-bone Cord Blood Transplantation in Patients With Haematological Malignancies


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to neutrophil recovery

Outcome Time Frame:

28 days after transplantation

Safety Issue:

No

Principal Investigator

Daniele Mattei, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

ASO S Croce e Carle

Authority:

Italy: Ethics Committee

Study ID:

Emato68

NCT ID:

NCT01613066

Start Date:

November 2008

Completion Date:

May 2013

Related Keywords:

  • High Risk Haematological Malignancies
  • Advanced Haematological Malignancies
  • Haematological malignancies
  • Allogeneic Cord Blood transplantation
  • Intrabone
  • Neoplasms
  • Hematologic Neoplasms

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