A multicenter Phase I/II trial investigating the safety and efficacy (CR rate and OS) of low dose AraC with Clofarabine in patients ≥60 years with AML not eligible for conventional Chemotherapy

Registry ID
EUCTR2009-017347-33
Source registry
EUCTR
Status
Prematurely Ended
Phase
PHASE2
Sponsor
University of Leipzig
Start date
2010-08-25
Completion date
2013-08-24
Last update
2026-08-16

Conditions

Summary

Phase I – Dose evaluation To investigate feasibility of induction therapy with low dose Ara-C (20 mg/m2 sc injection d1-d14) and clofarabine at three different dose levels for the first induction cycle (Clofarabine 10, 15 or 20 mg/m2 1h iv infusion d1-d5). Phase II – Safety To assess safety (in terms of AEs/ARs, SAEs/SARs and Adverse reactions CTC grade 4 (AR4)) of induction therapy with low dose AraC in combination with Clofarabine (at the dose level resulting from the dose evaluation phase of the trial).

Locations

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