Multicenter prospective observational study of hematopoietic stem cell transplantation after quizartinib in patients with FLT3-ITD positive relapsed or refractory acute myeloid leukemia .

Quizartinib cohort study bridging to hematopoietic stem cell transplantation in patients with FLT3-ITD positive acute myeloid leukemia; QUICHE study. - KSGCT2101(Quiche)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000043659

Enrollment

Registered

2021-04-01

Start date

2021-04-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Acute myeloid leukemia

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with written consent to participate in this study 2) Patients aged 20 to 70 years 3) Patients diagnosed with AML based on WHO classification (2017) 4) Untreated patients, patients with not achieved remission after induction therapies, or patients with progression after remission 5) Patients scheduled to receive quizartinib at the stage of disease ("primary" or "relapsed or refractory") at the time of enrollment. 6) Patients with ECOG PS 0 to 2 7) Patients who are scheduled to allogeneic stem cell transplantation 8) Patients who agree to contraception for several period of time (3 months for male and 6 months for female) during this study and after the final dose of quizartinib

Exclusion criteria

Exclusion criteria: 1) Patients treated with quizartinib 2) Patients with multiple malignancies other than AML 3) Patients diagnosed with acute promyelocytic leukemia 4) Patients with a QTcF (Fridericia-corrected QT interval) greater than 450 msec as a result of the latest electrocardiogram measured within 14 days prior to enrollment 5) Patients known to have HIV or HBV 6) Patients who have already achieved remission with treatment other than quizartinib at the stage of disease ("primary" or "relapsed or refractory") at the time of enrollment and are scheduled to receive allo-HSCT. 7) Pregnant or lactating patients, or patients who may be breastfeeding within 5 weeks of the last dose of quizartinib 8) Patients who are otherwise classified as unfit by the attending physicians for this research.

Design outcomes

Primary

Measure	Time frame
Clinical data of hematopoietic stem cell transplantation after quizartinib Reasons for allogeneic transplant Stem cell source Event-free survival: EFS Conditioning regimen Graft-versus-host disease :GVHD Cumulative incidences of relapse:CIR Cumulative incidences of non relapse mortality:NRM Clinical data for outcomes of quizartinib bridge to transplantation rate CRc[Composite complete remission]; CR[Complete remission]+CRi[Complete remission with incomplete hematologic recovery] Overall response rate: ORR Time to CRc Overall survival: OS Blood transfusion dependency rate Re-administration of quizartinib Adverse events of quizartinib	—

Measure

Time frame

Clinical data of hematopoietic stem cell transplantation after quizartinib Reasons for allogeneic transplant Stem cell source Event-free survival: EFS Conditioning regimen Graft-versus-host disease :GVHD Cumulative incidences of relapse:CIR Cumulative incidences of non relapse mortality:NRM Clinical data for outcomes of quizartinib bridge to transplantation rate CRc[Composite complete remission]; CR[Complete remission]+CRi[Complete remission with incomplete hematologic recovery] Overall response rate: ORR Time to CRc Overall survival: OS Blood transfusion dependency rate Re-administration of quizartinib Adverse events of quizartinib

—

Countries

Japan

Contacts

Public ContactHiroto Ishii

The Jikei University School of Medicine Division of Clinical Oncology and Hematology

ksgctdc@ksgct.net03-3433-1111

Outcome results