Individualized dosing of fludarabine during innate allo SCT: A randomized phase II study
Recruiting
- Conditions
- Hematological malignancies, Allogeneic stem cell transplantation, personalized dosing of fludarabine
- Registration Number
- NL-OMON24753
- Lead Sponsor
- niversity Medical Center Utrecht (UMCU)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 98
Inclusion Criteria
1. Adults (> 18 years)
2. AML, MDS, ALL, CML, CLL, NHL, HL, or a myeloproliferative disease (MPD)
Exclusion Criteria
1.Relapse of disease within 5 months after previous allo-SCT
2.Bilirubin and/or transaminases > 2.5 x normal value*
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cumulative incidence of severe viral infections at day 100
- Secondary Outcome Measures
Name Time Method -Non relapse mortality (NRM) at day 100<br /><br>-aGVHD grade II-IV at day 100<br /><br>-Donor engraftment (chimerism > 95%) at day 100<br /><br>-Overall survival at day 100<br /><br>-Cumulative incidence of relapse at day 100<br /><br>-Effective fludarabine exposure<br>