Transplantation of umbilical cord blood (UCB) from unrelated donors (URD) in patients with haematological diseases using a reduced intensity conditioning regimen. - RIC UCBT (Cord Blood)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-003845-41-GB

Enrollment

Registered

2009-01-16

Start date

2009-02-06

Completion date

Unknown

Last updated

2020-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haematological disorders MedDRA version: 14.1 Level: HLT Classification code 10018847 Term: Haematological disorders System Organ Class: 100000004851

Interventions

Product Name: Cyclophosphamide Product Code: Cyclophosphamide Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: CYCLOPHOSPHAMIDE CAS Number: 50180 Concentration unit: mg/kg mi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Age 60 years or younger and 2 years or older. 2) Umbilical cord blood graft available with an adequate cell dose and HLA match. 3) Disease for which an allogeneic haemopoietic stem cell transplant (HSCT) is indicated. 4) Adequate organ function. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1) Availability of a conventional related or unrelated haemopoietic stem cell donor. 2) Current active serious infection. 3) Previous irradiation that precludes the safe administration of an additional dose of 200 cGy of total body irradiation (TBI). 4) Refractory malignant disease. 5) Myelofibrosis

Design outcomes

Primary

Measure	Time frame
Main Objective: To validate the safety and efficacy of umbilical cord blood transplantation using a reduced intensity preparative regimen in patients with disorders of the blood using the approach developed by the University of Minnesota.;Secondary Objective: 1) To assess the safety and efficacy of this approach in children 2) To assess the way in which the immune system recovers after UCBT using this regimen 3) To assess the relative contribution of recipient and donor bone marrow function prior to day 21 after transplantation.;Primary end point(s): The primary end-point of this study is non-relapse mortality at day 100. Non-relapse mortality greater or equal to 50% within 100 days of transplant will stop the study. This is not a definitive efficacy study and statistical analysis will be descriptive. It is expected that a total of 15-20 patients will be enrolled per year for 3 years. Problems with count recovery, donor engraftment, severe GVHD (grade III-IV) and other adverse events will be continuously monitored throughout the study.	—

Measure

Time frame

Main Objective: To validate the safety and efficacy of umbilical cord blood transplantation using a reduced intensity preparative regimen in patients with disorders of the blood using the approach developed by the University of Minnesota.;Secondary Objective: 1) To assess the safety and efficacy of this approach in children 2) To assess the way in which the immune system recovers after UCBT using this regimen 3) To assess the relative contribution of recipient and donor bone marrow function prior to day 21 after transplantation.;Primary end point(s): The primary end-point of this study is non-relapse mortality at day 100. Non-relapse mortality greater or equal to 50% within 100 days of transplant will stop the study. This is not a definitive efficacy study and statistical analysis will be descriptive. It is expected that a total of 15-20 patients will be enrolled per year for 3 years. Problems with count recovery, donor engraftment, severe GVHD (grade III-IV) and other adverse events will be continuously monitored throughout the study.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 14, 2026