No registrations found.
ID
Source
Brief title
Health condition
Patients aged 18 -65 years inclusive, with high-risk hematological disease, eligible for allo MUD-SCT,
lacking a matched unrelated donor and with
availability of 2 (¡Ý 4/6) matched UCB units
Sponsors and support
Intervention
Outcome measures
Primary outcome
The 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 outcome
1. 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.
Background summary
N/A
Study objective
N/A
Study design
At 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.
Intervention
Patients 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).
P.O. Box 5201
J.J. Cornelissen
Rotterdam 3008 AE
The Netherlands
+31 (0)10 4391598 or +31 (0)10 4391367
j.cornelissen@erasmusmc.nl
P.O. Box 5201
J.J. Cornelissen
Rotterdam 3008 AE
The Netherlands
+31 (0)10 4391598 or +31 (0)10 4391367
j.cornelissen@erasmusmc.nl
Inclusion criteria
1. 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 criteria
1. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3393 |
| NTR-old | NTR3535 |
| Other | HOVON : HO115 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |