Multi-center non-randomized open trial to evaluate the efficacy of azacitidine followed by allo-HSCT for TP53(+) MDS.

Multi-center non-randomized open trial to evaluate the efficacy of azacitidine followed by allo-HSCT for TP53(+) MDS. - REPTAT trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000027789

Enrollment

Registered

2017-06-20

Start date

2017-10-18

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

myelodysplastic syndromes

Interventions

azacitidine treatment followed by allogeneic HSCT

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) MDS or MDS/MPN(CMML) according to WHO classification (4th) or MDS (RAEB-t) according to FAB classification. (2) Age between 16 and 69. (3) No history of azacitidine treatment OR on azacitidine treatment and fulfills all of the following conditions; *On azacitidine treatment *Total interruption period of azacitidine <3 months. *Efficacy of azacitidine be SD or above. *Specimen of bone marrow and/or peripheral blood is available for genetic study. (4) Indication for allogeneic HSCT, and the patient has the will. (5) ECOG Performance status (PS) 0-2 (6) Sufficient organ function to receive therapy (fulfill all of the below conditions) *T.Bil<2.0mg/dL *Cre<2.0mg/dL *GOT/GPT< 3x ULN *No serious heart or lung diseases. (7) Provide written informed consent to join the study on his/her free-will.

Exclusion criteria

Exclusion criteria: (1) Previous history of allo-HSCT. (2) Obviously refractory to azacitidine, or planning allo-HSCT for disease progression after azacitidine treatment. (3) Active comorbid malignancy (less than 5 years after cure) except for myeloid malignancies that are assumed to be associated with MDS development. (4) Have uncontrollable infections. (5) Have psychiatric disorders requiring major tranquilizers. (6) During pregnancy or suspected pregnancy. (7) Positive for either HBs-Ag, HCV-Ab, HIV-Ab. (8) Assumed inappropriate to register the study by the attending doctors.

Design outcomes

Primary

Measure	Time frame
2-year OS after allogeneic hematopoietic stem cell transplantation.	—

Countries

Japan

Contacts

Public ContactYasuito Nannya

Kyoto University Dep. of Pathol. & Tumor Biol.

ynanya-tky@umin.ac.jp075-753-9285

Outcome results

None listed

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