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Double umbilical cord blood transplantation in high-risk hematological patients.
A phase II study focussing on the mechanism of graft predominance.



- candidate number13155
- NTR NumberNTR3535
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-jul-2012
- Secondary IDsHO115 HOVON
- Public TitleDouble umbilical cord blood transplantation in high-risk hematological patients.
A phase II study focussing on the mechanism of graft predominance.
- Scientific TitleDouble umbilical cord blood transplantation in high-risk hematological patients.
A phase II study focussing on the mechanism of graft predominance.
- ACRONYMHOVON 115 DOUBLE UCBT
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedHigh risc hematological disease
- Inclusion criteria1. Age 18-65 years inclusive;
2. Diagnosis of poor-risk hematological malignancy or (V)SAA relapsing after or failing immunosuppressive therapy and meeting the criteria for a MUD allo SCT;
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 alloSCT;
4. Availability of 2 (≥4/6) matched UCB grafts with a total nuclear cell count > 4 x 107/kg (see paragraph 8.2);
5. WHO performance status 0-2;
6. Written informed consent.
- Exclusion criteria1. Bilirubin and/or transaminases > 2.5 x normal value;
2. Creatinine clearance < 40 ml/min;
3. Cardiac dysfunction as defined by:
A. Reduced left ventricular function with an ejetion fraction < 45% as measured by MUGA scan or echocardiogram (another method for measuring cardiac function is acceptable);
B. Unstable angina;
C. Unstable cardiac arrhythmias.
4. Pulmonary function test with VC, FEV1 and/ or DCO < 50%;
5. Active, uncontrolled infection;
6. History of high dose (≥ 8 Gy) total body irradiation;
6. Pregnant or lactating females;
7. HIV positivity.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 25-aug-2012
- planned closingdate25-aug-2015
- Target number of participants70
- InterventionsPatients are treated with a reduced-intensity conditioning regimen, irrespective of patient age, followed by double UCBT. Post grafting immunosuppression is performed by mycophenolate mofetil (30 days) and cyclosporine A (90 days, taper thereafter).
- Primary outcomeThe proportion of patients with activated class II-specific T-cells (aTCs), defined as: the number of patients with aTCs, divided by the number of patients with class II mismatches for which there are tests available (defined as evaluable patients).
- Secondary outcome1. Cumulative incidence of engraftment;
2. Cumulative incidence of graft failure;
3. Time to neutrophil recovery;
4. Time to lymphocyte recovery;
5. Time to platelet recovery;
6. Time to red blood cell transfusion independence;
7. Count of total CD3+, CD4+,CD8+ and CD19+ cells and CD3-CD16/56+ cells at 1,2, 3, 6, 12 and 24 months after UCBT;
8. Incidence and grade of acute GVHD;
9. Incidence of chronic GVHD;
10. Incidence of infections;
11. Transplant related mortality (TRM; defined as non-relapse mortality);
12. Progression free survival (PFS, i.e. time from transplantation until progression/relapse or death from any cause, whichever comes first);
13. Overall survival (OS) calculated from transplantation. Patients still alive or lost to follow up are censored at the date they were last known to be alive.
- TimepointsAt entry: Within 30 days before start of treatment.
After: 1, 2, 3, 6, 12 and 24 months after transplantation and yearly therafter.

All patients will be followed until 5 years after registration.
- Trial web sitewww.hovon.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. J.J. Cornelissen
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J.J. Cornelissen
- Sponsor/Initiator HOVON Data Center
- Funding
(Source(s) of Monetary or Material Support)
HOVON
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD19-jul-2012 - 28-aug-2012


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