Summary of unpublished phase 2/3 trials examining a combination of standard chemotherapy with and without FLT3-TKI in newly diagnosed patients
| TKI . | Clinical phase . | Title . | Chemotherapy . | Patient number . | Age (years) . | Principal investigator . | Remarks . |
|---|---|---|---|---|---|---|---|
| Midostaurin (PKC412) | 3 | A phase 3 randomized, double-blind study of induction (Daunorubicin/Cytarabine) and consolidation (high-dose Cytarabine) chemotherapy plus Midostaurin or placebo in newly diagnosed patients < 60 years of age with FLT3 mutated acute myeloid leukemia | Induction: AraC 200 mg/m2/d, days 1-7; Daunorubicin 60 mg/m2/d, days 1-3; consolidation: AraC 3 g/m2/d, days 1, 3, 5 either plus Midostaurin or placebo followed by 12 cycles maintenance with Midostaurin/placebo | 514 FLT3 mutated patients planned | 18-60 | Dr Richard Stone, Dana-Farber Cancer Institute, Boston, USA | Placebo-controlled. International. Recruiting Reference: NCT00651261 |
| Lestaurtinib (CEP-701) | 3 | MRC AML 15: a trial of directed therapy in younger patients with acute myeloid leukemia: MRC AML 15 | Induction: AraC plus Daunorubicin ± Etoposide; consolidation: 2-3× HD-AraC or MACE plus MidAC;± Lestaurtinib for FLT3-mut pts. (randomized) | Target number of patients: 2500 | 18-60 | Dr Alan Burnett, Cardiff University, Cardiff, UK | Open label, international. Recruitment completed. Results have not been published yet. Reference: ISRCTN 17161961 http://www.download.bham.ac.uk/bctu/AML15/AML15%20Protocol%20Version%206.pdf |
| Lestaurtinib (CEP-701) | 3 | MRC AML 17: a program of treatment development in younger patients with acute myeloid leukemia and high risk myelodysplastic syndrome | Induction: 2× AraC plus Daunorubicin ± Etoposide ± Mylotarg consolidation: 1× MACE ± MidAC;± Lestaurtinib for FLT3-mut pts. after 1 induction (randomized) | Target number of patients: 2800 | 18-60 | Dr Alan Burnett, Cardiff University, Cardiff, UK | Open label, international. Recruiting Reference: ISRCTN 55675535 http://aml17.cardiff.ac.uk/files/aml17_protocolv2.pdf |
| Sorafenib | 2 | A double blind, placebo-controlled, randomized, multicenter phase-II trial to assess the efficacy of Sorafenib added to standard primary therapy in patients with newly diagnosed AML ≤ 60 years of age | Induction: 2× AraC plus Daunorubicin; consolidation: 3× HD-AraC; either plus Sorafenib or placebo followed by maintenance with Sorafenib/placebo | 276 FLT3-mutated patients planned | 18-60 | Dr Gerhard Ehninger, Technical University Dresden, Germany | Placebo-controlled Recruiting Reference: http://www.leukemia-net.org/trial/download/public/AML_SOR_Kurzprotokoll.pdf?id=821 |
| Sorafenib | 2 | Efficacy of Sorafenib added to standard primary therapy in elderly patients with newly diagnosed AML | 1-2× induction chemotherapy; 2× consolidation chemotherapy; either Sorafenib or placebo between chemo. cycles, followed by maintenance therapy with Sorafenib/placebo | 200 FLT3 mutated patients accrued | 18-60 | Dr Hubert Serve, Wolfgang-Goethe-University, Frankfurt, Germany | Double-blind, placebo-controlled. Completed;Results have not been published yet. Reference: NCT00373373 |
| Sunitinib | 1/2 | Clinical study of SU11248 (Sutent) combined with standard chemotherapy in patients with FLT3 mutated AML > 60 years | AraC plus Daunorubicin plus Sunitinib (different dose levels and schedules) | 30 FLT3 mutated patients planned | > 60 | Dr Walter Fiedler, University Medical Center, Hamburg-Eppendorf, Germany | Open-label, single group. Recruiting. Reference: NCT00783653 |
| TKI . | Clinical phase . | Title . | Chemotherapy . | Patient number . | Age (years) . | Principal investigator . | Remarks . |
|---|---|---|---|---|---|---|---|
| Midostaurin (PKC412) | 3 | A phase 3 randomized, double-blind study of induction (Daunorubicin/Cytarabine) and consolidation (high-dose Cytarabine) chemotherapy plus Midostaurin or placebo in newly diagnosed patients < 60 years of age with FLT3 mutated acute myeloid leukemia | Induction: AraC 200 mg/m2/d, days 1-7; Daunorubicin 60 mg/m2/d, days 1-3; consolidation: AraC 3 g/m2/d, days 1, 3, 5 either plus Midostaurin or placebo followed by 12 cycles maintenance with Midostaurin/placebo | 514 FLT3 mutated patients planned | 18-60 | Dr Richard Stone, Dana-Farber Cancer Institute, Boston, USA | Placebo-controlled. International. Recruiting Reference: NCT00651261 |
| Lestaurtinib (CEP-701) | 3 | MRC AML 15: a trial of directed therapy in younger patients with acute myeloid leukemia: MRC AML 15 | Induction: AraC plus Daunorubicin ± Etoposide; consolidation: 2-3× HD-AraC or MACE plus MidAC;± Lestaurtinib for FLT3-mut pts. (randomized) | Target number of patients: 2500 | 18-60 | Dr Alan Burnett, Cardiff University, Cardiff, UK | Open label, international. Recruitment completed. Results have not been published yet. Reference: ISRCTN 17161961 http://www.download.bham.ac.uk/bctu/AML15/AML15%20Protocol%20Version%206.pdf |
| Lestaurtinib (CEP-701) | 3 | MRC AML 17: a program of treatment development in younger patients with acute myeloid leukemia and high risk myelodysplastic syndrome | Induction: 2× AraC plus Daunorubicin ± Etoposide ± Mylotarg consolidation: 1× MACE ± MidAC;± Lestaurtinib for FLT3-mut pts. after 1 induction (randomized) | Target number of patients: 2800 | 18-60 | Dr Alan Burnett, Cardiff University, Cardiff, UK | Open label, international. Recruiting Reference: ISRCTN 55675535 http://aml17.cardiff.ac.uk/files/aml17_protocolv2.pdf |
| Sorafenib | 2 | A double blind, placebo-controlled, randomized, multicenter phase-II trial to assess the efficacy of Sorafenib added to standard primary therapy in patients with newly diagnosed AML ≤ 60 years of age | Induction: 2× AraC plus Daunorubicin; consolidation: 3× HD-AraC; either plus Sorafenib or placebo followed by maintenance with Sorafenib/placebo | 276 FLT3-mutated patients planned | 18-60 | Dr Gerhard Ehninger, Technical University Dresden, Germany | Placebo-controlled Recruiting Reference: http://www.leukemia-net.org/trial/download/public/AML_SOR_Kurzprotokoll.pdf?id=821 |
| Sorafenib | 2 | Efficacy of Sorafenib added to standard primary therapy in elderly patients with newly diagnosed AML | 1-2× induction chemotherapy; 2× consolidation chemotherapy; either Sorafenib or placebo between chemo. cycles, followed by maintenance therapy with Sorafenib/placebo | 200 FLT3 mutated patients accrued | 18-60 | Dr Hubert Serve, Wolfgang-Goethe-University, Frankfurt, Germany | Double-blind, placebo-controlled. Completed;Results have not been published yet. Reference: NCT00373373 |
| Sunitinib | 1/2 | Clinical study of SU11248 (Sutent) combined with standard chemotherapy in patients with FLT3 mutated AML > 60 years | AraC plus Daunorubicin plus Sunitinib (different dose levels and schedules) | 30 FLT3 mutated patients planned | > 60 | Dr Walter Fiedler, University Medical Center, Hamburg-Eppendorf, Germany | Open-label, single group. Recruiting. Reference: NCT00783653 |