Double umbilical cord blood transplantation in high-risk hematological patients.A phase II study focussing on the mechanism of graft predominance
- Conditions
- Patients with high-risk hematological diseases, who need a allogeneic stem cell transplantation but who lack a matched unrelated donorMedDRA version: 14.1Level: PTClassification code 10061187Term: Haematopoietic neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-001188-55-BE
- Lead Sponsor
- HOVON Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 70
•Age 18-70 years inclusive
•Diagnosis of poor-risk hematological malignancy or (V)SAA relapsing after or failing immunosuppressive therapy and meeting the criteria for a MUD allo SCT
•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 alloSCT
•Availability of 2 (=4/6) matched UCB grafts with a total nuclear cell count > 4 x 107/kg
Are the trial subjects under 18? no
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 68
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2
•Bilirubin and/or transaminases > 2.5 x normal value
•Creatinine clearance < 40 ml/min
•Cardiac dysfunction as defined by:ejection fraction < 45%,unstable angina, unstable cardiac arrhythmias
• Pulmonary function test with VC, FEV1 and/ or DCO < 50%
•Active, uncontrolled infection
•History of high dose (= 8 Gy) total body irradiation
•Pregnant or lactating females
•HIV positivity
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method