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A phase II study to assess engraftment and engraftment kinetics after double cord blood transplantation with a reduced-intensity conditioning regimen in patients eligible for allogeneic stem cell transplantation lacking a matched unrelated donor.

A phase II study to assess engraftment and engraftment kinetics after double cord blood transplantation with a reduced-intensity conditioning regimen in patients eligible for allogeneic stem cell transplantation lacking a matched unrelated donor.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26715
Enrollment
40
Registered
2008-12-03
Start date
2008-11-26
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Patients with high-risk hematological malignancies (acute myeloid leukemia, acute lymphoblastic leukemia or myelodysplastic syndrome with high-risk characteristics

Interventions

Patients eligible for allogeneic stem cell transplantation lacking a matched unrelated donor are transplanted with a double cord blood graft. Transplantation will be preceded by a reduced-intensity co

Sponsors

Erasmus Medical Centre Rotterdam Department of Hematology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18-65 years inclusive. 2. Meeting the criteria for a MUD allo SCT and high risk disease. 3. Lacking a sufficiently matched volunteer unrelated donor or lacking such a donor within the required time period of =< 2 months in case of urgently needed allo SCT. 4. Availability of 2 sufficiently matched UCB grafts with a total nucleated cell count of at least 4x10.7/kg. 5. WHO performance status =< 2. 6. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Relapse APL. 2. Primary myelofibrosis. 3. Bilirubin and/or transaminases > 2.5 x normal value. 4. Creatinine clearance < 40 ml/min. 5. Cardiac dysfunction as defined by: - reduced left ventricular function with an ejection fraction < 45% as measured by MUGA scan or echocardiogram - unstable angina or unstable cardiac arrhythmias. 6. Pulmonary function test with VC, FEV1 and/ or DCO < 50%. 7. Active, uncontrolled infection. 8. History of high dose total body irradiation. 9. HIV positivity.

Design outcomes

Primary

MeasureTime frame
The cumulative incidence of graft failure.—

Secondary

MeasureTime frame
1. Time to engraftment of different cell subset'; 2. time to platelet transfusion independence; 3. time to red blood cell transfusion independence; 4. incidence and grade of acute GVHD; 5. incidence of chronic GVHD; 6. incidence of infections; 7. transplant related mortality (TRM); 8. progression free survival and overall survival.—

Contacts

Public ContactJ.A.E. Somers

Erasmus MC-Daniel den Hoed Room G-350 P.O. Box 2040

j.somers@erasmusmc.nl+31 (0)10 7041367

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)