Double umbilical cord blood transplantation in high-risk hematological patients.A phase II study focussing on the mechanism of graft predominance.
Recruiting
- Conditions
- 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
- Registration Number
- NL-OMON22961
- Lead Sponsor
- HOVON Data Center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 70
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;
Exclusion Criteria
1. Bilirubin and/or transaminases > 2.5 x normal value;
2. Creatinine clearance < 40 ml/min;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 1. Cumulative incidence of engraftment;<br /><br>2. Cumulative incidence of graft failure;<br /><br>3. Time to neutrophil recovery;<br /><br>4. Time to lymphocyte recovery;<br /><br>5. Time to platelet recovery;<br /><br>6. Time to red blood cell transfusion independence;<br /><br>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;<br /><br>8. Incidence and grade of acute GVHD;<br /><br>9. Incidence of chronic GVHD;<br /><br>10. Incidence of infections;<br /><br>11. Transplant related mortality (TRM; defined as non-relapse mortality);<br /><br>12. Progression free survival (PFS, i.e. time from transplantation until progression/relapse or death from any cause, whichever comes first);<br /><br>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.