The phase II study for evaluating the effectiveness and safety of allogeneic hematopoietic stem cell transplantation for adult acute myeloid leukemia with FLT3/ITD mutation. -JALSG AML209-FLT3-SCT Study (AML209-FLT3-SCT)-

The phase II study for evaluating the effectiveness and safety of allogeneic hematopoietic stem cell transplantation for adult acute myeloid leukemia with FLT3/ITD mutation. -JALSG AML209-FLT3-SCT Study (AML209-FLT3-SCT)- - Allogeneic hematopoietic stem cell transplantation for adult acute myeloid leukemia with FLT3/ITD mutation.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003433

Enrollment

Registered

2010-04-02

Start date

2010-02-01

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

After the consolidation therapies (1 to 4 courses), allogeneic hematopoietic stem cell transplantation is performed.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) JALSG AML209-GS study registered patient. (2) The patients without RUNX1-RUNX1T1, CBFB-MYH11 and PML-RARA transcripts. (3) The patients with FLT3/ITD mutation. (4) The patients who achieved CR within 2 courses of the induction therapy (5) The patients who are not received the post-remission therapy. (6) The patients with Performance status grade (ECOG) 0,1 or 2. (7) The patients with the chemotherapy tolerable liver, kidney, lung and cardiac functions.

Exclusion criteria

Exclusion criteria: (1) Secondary AML (2) The patients with the past history of hematopoietic disorder. (3) The patients who received the induction therapy consisted of Gemtuzumab ozogamicin (Mylotarg). (4) The patients who have been identified the cancer after the registration to the JALSG AML209-GS study. (5) The patients who have developed myocardial infarction or angina after the registration to the JALSG AML209-GS study. (6) The patients with cardiac dysfunction. (7) The patients with active gastric ulcer. (8) The patients with the uncontrollable ileus. (9) The patients with the diabetes mellitus. (10) The patients with active infection. (11) The patients in whom the HBV-reactivation have been observed. (12) Psycological patients.

Design outcomes

Primary

Measure	Time frame
Disease-free survival at the 3 year.	—

Countries

Japan

Contacts

Public ContactHitoshi Kiyoi

Nagoya University Hospital Department of Hematology

kiyoi@med.nagoya-u.ac.jp052-744-2136

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026