Individualized dosing of fludarabine during innate allo SCT: A randomized phase II study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24753

Enrollment

Registered

2018-04-09

Start date

2018-06-01

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematological malignancies, Allogeneic stem cell transplantation, personalized dosing of fludarabine

Interventions

Patients will be randomized to either to standard dosing of fludarabine or individualized fludarabine dosing as part of a conditioning regimen, followed by an &#945

&#946

TCR / CD19 depleted transplantation.

Eligibility

Inclusion criteria

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

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 II (Appendix B) -Cardiac symptoms and/or history of cardiac disease AND a cardiac ejection fraction < 45% 5.Active, uncontrolled infection

Design outcomes

Primary

Measure	Time frame
Cumulative incidence of severe viral infections at day 100	—

Secondary

Measure	Time frame
-Non relapse mortality (NRM) at day 100 -aGVHD grade II-IV at day 100 -Donor engraftment (chimerism > 95%) at day 100 -Overall survival at day 100 -Cumulative incidence of relapse at day 100 -Effective fludarabine exposure	—

Contacts

Public ContactC.A. Nijssen

Afdeling Hematologie

c.a.nijssen@umcutrecht.nl0887555878

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)