scholarly journals A prospective phase II randomized study of deferasirox to prevent iatrogenic iron overload in patients undertaking induction/consolidation chemotherapy for acute myeloid leukaemia

2013 ◽  
Vol 161 (6) ◽  
pp. 794-801 ◽  
Author(s):  
Glen A. Kennedy ◽  
Kirk L. Morris ◽  
Elango Subramonpillai ◽  
Cameron Curley ◽  
Jason Butler ◽  
...  
Keyword(s):  
Acute Myeloid Leukaemia ◽  
Iron Overload ◽  
Myeloid Leukaemia ◽  
Phase Ii ◽  
Randomized Study ◽  
Consolidation Chemotherapy ◽  
Prospective Phase ◽  
Acute Myeloid

A phase II trial of high-dose imatinib mesylate for relapsed or refractory c-kit positive and Bcr-Abl negative acute myeloid leukaemia: The AFR-15 trial

2009 ◽  
Vol 33 (8) ◽  
pp. 1124-1126 ◽  
Author(s):  
Patrice Chevallier ◽  
Mathilde Hunault-Berger ◽  
Fabrice Larosa ◽  
Charles Dauriac ◽  
Richard Garand ◽  
...  
Keyword(s):  
Acute Myeloid Leukaemia ◽  
Myeloid Leukaemia ◽  
Imatinib Mesylate ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
High Dose ◽  
Acute Myeloid

471 POSTER Plasma pharmacokinetics of CP-4055 in patients with acute myeloid leukaemia at the recommended phase II dose

2008 ◽  
Vol 6 (12) ◽  
pp. 150-151
Author(s):  
S. Hagen ◽  
S.M. O'Brien ◽  
T.F. Jacobsen ◽  
H.M. Kantarjian ◽  
M.L. Sandvold ◽  
...  
Keyword(s):  
Acute Myeloid Leukaemia ◽  
Myeloid Leukaemia ◽  
Phase Ii ◽  
Plasma Pharmacokinetics ◽  
Recommended Phase Ii Dose ◽  
Acute Myeloid

Results of a Prospective Phase II Randomized Study of Deferasirox (Exjade®) to Prevent Iatrogenic Iron Overload in Patients Undertaking Induction/Consolidation Chemotherapy for Acute Myeloid Leukaemia (HREC/10/QRBW/135)

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 3577-3577
Author(s):  
Glen A Kennedy ◽  
Kirk Morris ◽  
Elango Pillai ◽  
Cameron Curley ◽  
Jason P. Butler ◽  
...  
Keyword(s):  
Iron Overload ◽  
Phase Ii ◽  
Conflicts Of Interest ◽  
Randomized Study ◽  
Significant Risk ◽  
Maximum Tolerated Dose ◽  
Chemotherapy Cycle ◽  
Consolidation Chemotherapy ◽  
Ferritin Concentration ◽  
To Receive

Abstract Abstract 3577 Background: Iron overload, as measured by raised serum ferritin, is recognised as a significant risk factor for excess transplant related mortality (TRM) in allogeneic stem cell transplantation (SCT). Due to blood transfusions received during initial induction/consolidation chemotherapy, almost all patients undertaking SCT with AML have significantly raised ferritin pre-SCT. Aims: To determine the efficacy of deferasirox (Exjade®) in preventing iatrogenic iron overload in patients receiving induction/consolidation chemotherapy for AML. Methods: Prospective randomised phase II study in AML patients planned to receive induction and/or consolidation chemotherapy. Iron studies and CRP were measured pre, mid and post each chemotherapy cycle. Patients were randomised to receive either therapy with deferasirox (starting at 5–10mg/kg/day PO and increasing to maximum 40mg/kg/day PO as tolerated) vs. no deferasirox therapy. Desferasirox was commenced once ferritin increased to >500μg/L and continued until transfusion independence after completion of all chemotherapy. The primary endpoint was ferritin concentration at completion of chemotherapy. Based on historical controls, to detect a difference of >1000μg/L in ferritin between groups a sample size of 14 per arm was required. Results: The study was terminated prematurely after 16 patients were enrolled (deferasirox arm n=10; control arm n=6) due to excess grade 2–4 GIT (frequency 1.26 vs. 0.75 events/chemotherapy cycle for deferasirox vs. control arm respectively; p=0.04) and infectious toxicity (frequency 2.22 vs. 1.38 events/chemotherapy cycle for deferasirox vs. control arm respectively; p=0.05) experienced in the deferasirox arm. Overall desferasirox was poorly tolerated, with mean maximum tolerated dose only 13.2mg/kg/day (range 5–20mg/kg/day) and 4/10 patients unable to continue the drug predominantly due to GIT toxicity. Post-treatment ferritin, % change in ferritin and number of transfusions received were no different between arms. Post-chemotherapy CR rate was lower in the desferasirox arm (60% vs. 100%; p=0.234), and all treatment-related deaths (n=3; all infectious-related) occurred in the desferasirox arm (p=0.25). Median OS was similar in both arms (median 450 vs. 476 days for deferasirox vs. control arm respectively; p=0.72). Conclusions: Use of desferasirox to prevent iatrogenic iron overload in AML patients undertaking induction/consolidation is ineffective, poorly tolerated, and associated with excess GIT and infectious toxicity. Disclosures: No relevant conflicts of interest to declare.

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