Individualized dosing of fludarabine during innate allo SCT: A randomized phase II study (TARGET Study)

Phase 2

Recruiting

• Conditions: hematological malignancies; blood cancer; 10024324

• Registration Number: NL-OMON55832
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

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)
3. Indication for allo-SCT according to the policy of the local center
4. WHO performance status <= 2
5. Written informed consent

Exclusion Criteria

1. Relapse of disease within 5 months after previous allo-SCT
2. Bilirubin and/or transaminases > 2.5 x normal value*
3. Creatinine clearance < 40 ml/min
4. Cardiac dysfunction as defined by:
- Unstable angina or unstable cardiac arrhythmias
- NYHA classification > II (Appendix B)
- Cardiac symptoms and/or history of cardiac disease AND a cardiac ejection
fraction <45%
5. Active, uncontrolled infection

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Cumulative incidence of severe viral infections at day 100.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- 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 /><br>- Cost effectiveness at 2 years</p><br>