Transplantation of umbilical cord blood from unrelated donors in patients with haematological diseases using a myeloablative conditioning regimen - MAC UCBT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-011818-21-GB

Enrollment

Registered

2010-06-18

Start date

2010-06-28

Completion date

Unknown

Last updated

2015-08-04

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

Conditions

Haematological disorders MedDRA version: 15.1 Level: HLT Classification code 10018847 Term: Haematological disorders System Organ Class: 100000004851

Interventions

Product Name: Cyclophosphamide Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: Cyclophosphamide CAS Number: 50-18-0 Concentration unit: mg/ml milligram(s)/millilitre Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Age 45 years or younger. Children under the age of 2 years are at an increased risk of long term complications of total body irradiation (TBI) and will therefore not recieve TBI (AML patients aged =65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: 1) Availability of a conventional related or unrelated haemopoietic stem cell donor within an acceptable time period. Such donors represent the standard of care in UK transplantation and must remain the first choice where available. 2) Current active serious infection. The preparative regimen results in profound suppression of the white count and immune system. Patients with active serious infection, such as invasive fungus, could develop life-threatening infection after transplant and will therefore be excluded. 3) Previous irradiation that precludes the safe administration of 13.2Gy- 14.4Gy of total body irradiation (TBI) in patients over 2 years of age and AML patients over the age of 16. Every patient scheduled to recieve TBI will be reviewed by a radiation oncologist to ensure that this dose of TBI will be safe. Children under the age of 2 years are at an increased risk of long term complications and will therefore not recieve TBI (AML patients aged <16 years will also not receive TBI as chemotherapy-only conditioning is now accepted national practice for this population). 4) Prior autograft.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the safety and efficacy of unrelated donor umbilical cord blood transplantation (UCBT) in a multi-institution UK setting where the use a myeloablative preparative regimen is indicated. The anti-malignancy effect of this treatment is achieved by a combination of intensive chemoradiotherapy and the 'graft vs. malignancy' (GVM) effect. The advantage of this approach is the increased likelihood of destroying the malignant cells and a reduced risk of graft rejection as the bone marrow is better prepared to accept the transplant than with reduced intensity conditioning. However, the treatment may be less well tolerated by some patients and therefore patients of advanced age or with impaired organ function are not eligible for this trial.;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 a myeloablative regimen 3) to assess the relative contribution of recipient and donor bone marrow function 21 days post-transplant 4) To assess transplant related mortality associated with myeloablative UCBT at day 100 post-transplant 5) To assess the incidence of grades II-IV and III-IV acute graft-versus-host disease (GVHD) 6) To assess the risk of relapse and progressive disease at 1 year post-transplant after myeloablative UCBT 7) To assess overall and progression-free survival at 1 year after myeloablative UCBT;Primary end point(s): The primary end-point of this study is non-relapse mortality at day 100.	—

Measure

Time frame

Main Objective: To assess the safety and efficacy of unrelated donor umbilical cord blood transplantation (UCBT) in a multi-institution UK setting where the use a myeloablative preparative regimen is indicated. The anti-malignancy effect of this treatment is achieved by a combination of intensive chemoradiotherapy and the 'graft vs. malignancy' (GVM) effect. The advantage of this approach is the increased likelihood of destroying the malignant cells and a reduced risk of graft rejection as the bone marrow is better prepared to accept the transplant than with reduced intensity conditioning. However, the treatment may be less well tolerated by some patients and therefore patients of advanced age or with impaired organ function are not eligible for this trial.;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 a myeloablative regimen 3) to assess the relative contribution of recipient and donor bone marrow function 21 days post-transplant 4) To assess transplant related mortality associated with myeloablative UCBT at day 100 post-transplant 5) To assess the incidence of grades II-IV and III-IV acute graft-versus-host disease (GVHD) 6) To assess the risk of relapse and progressive disease at 1 year post-transplant after myeloablative UCBT 7) To assess overall and progression-free survival at 1 year after myeloablative UCBT;Primary end point(s): The primary end-point of this study is non-relapse mortality at day 100.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026