(QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD Positive
Summary
The primary objective of the study is to determine whether quizartinib monotherapy prolongs overall survival (OS) compared to salvage chemotherapy in subjects with FMS-like tyrosine kinase 3 - Internal Tandem Duplication (FLT3-ITD) positive AML who are refractory to or have relapsed within 6 months, after first-line AML therapy.
Timeline
- Start
- 2014-05
- Primary completion
- 2018-02-22
- Completion
- 2020-09-08
Outcome
Met primary endpoint
registry analysis (other test); Quizartinib vs Salvage Chemotherapy; p = 0.0185; Hazard Ratio (HR) 0.758 (95% CI 0.584 to 0.983); P-value for HR=1 (1-sided) NCT02039726 ↗
paper Overall survival was longer for quizartinib than for chemotherapy (hazard ratio 0·76 [95% CI 0·58-0·98; p=0·02). PMID 31175001 ↗
release “the pivotal QuANTUM-R phase 3 study of single agent quizartinib met its primary endpoint of significantly prolonging overall survival compared to salvage chemotherapy” daiichisankyo.com ↗
Publications
- Kang D, Ludwig E, Jaworowicz D, Huang H, Fiedler-Kelly J, Cortes J, Ganguly S, Khaled S, Kramer A, Levis M, Martinelli G, Perl A, Russell N, Abutarif M, Choi Y, Yin O. Concentration-QTc analysis of quizartinib in patients with relapsed/refractory acute myeloid leukemia. Cancer Chemother Pharmacol. 2021 Apr;87(4):513-523. doi: 10.1007/s00280-020-04204-y. Epub 2021 Jan 8.
- Cortes JE, Khaled S, Martinelli G, Perl AE, Ganguly S, Russell N, Kramer A, Dombret H, Hogge D, Jonas BA, Leung AY, Mehta P, Montesinos P, Radsak M, Sica S, Arunachalam M, Holmes M, Kobayashi K, Namuyinga R, Ge N, Yver A, Zhang Y, Levis MJ. Quizartinib versus salvage chemotherapy in relapsed or refractory FLT3-ITD acute myeloid leukaemia (QuANTUM-R): a multicentre, randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2019 Jul;20(7):984-997. doi: 10.1016/S1470-2045(19)30150-0. Epub 2019 Jun 4.
- Cortes J, Perl AE, Dohner H, Kantarjian H, Martinelli G, Kovacsovics T, Rousselot P, Steffen B, Dombret H, Estey E, Strickland S, Altman JK, Baldus CD, Burnett A, Kramer A, Russell N, Shah NP, Smith CC, Wang ES, Ifrah N, Gammon G, Trone D, Lazzaretto D, Levis M. Quizartinib, an FLT3 inhibitor, as monotherapy in patients with relapsed or refractory acute myeloid leukaemia: an open-label, multicentre, single-arm, phase 2 trial. Lancet Oncol. 2018 Jul;19(7):889-903. doi: 10.1016/S1470-2045(18)30240-7. Epub 2018 May 31.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cytarabine | Small molecule | 20 mg | Subcutaneous |
| Comparator | Cytarabine | Small molecule | 1000 mg/m2 | Subcutaneous |
| Comparator | Cytarabine | Small molecule | 2000 mg/m2 | Subcutaneous |
| Comparator | Etoposide | Small molecule | 100 mg/m2 | Intravenous |
| Comparator | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |
| Comparator | Idarubicin | Small molecule | 10 mg/m2 | Intravenous |
| Comparator | Mitoxantrone | Small molecule | 8 mg/m2 | Intravenous |
| Subject | Quizartinib | Small molecule | 20 mg | Oral |
| Subject | Quizartinib | Small molecule | 30 mg | Oral |