A study of thronbomodulin-arfa prophylactic use for adverse effects and non-relapse mortality in allogeneic stem cell transplantation in elderly patients with hematological diseases

Safty and efficacy of preparative regimens combined with thrombomodulin-alfa in allogeneic stem cell transplantation in elderly patients with hematological diseases ~Examine the safety of combination of preparative regimens and thrombomodulin-alfa ~ - rTM001 study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031190075

Enrollment

Registered

2019-08-14

Start date

2019-08-14

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

Hematological disease with stem cell transplant adaptation acute myeloid leukemia myelodysplastic syndrome

Interventions

By combining thrombomodulin-alpha, which has the function of protecting the vascular endothelium, in combination with preparative regimens for transplantation, it is hypothesized that vascular endothe

preparative regimens thrombomoduline alfa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Over 65 yo with hematological malignanncies who have no curable treatment with comventional therapy except allogeneic stem cell transplantation 2. Patines scheduled allogeneic stem cell transplantation including bone marrow transplantatin or peripheral blood stem cell transplantation or umbilical cord blood transplantain 3. Patients' Age between 65 yo up to 80 yo 4.Written informed consent

Exclusion criteria

Exclusion criteria: 1. Eastern Cooperative Oncology Group Performance status over 2 2. Under 50% ejection fraction by echocardiography 3. Abnomal ECG including ischemic change or arrhythmia to need treatment 4. Under 93% sO2 under room air 5. Serum creatinine over 2.0 mg per dL 6. Total bilirubin over 1.6 mg per dL or AST over twice maximum normal level 7. Adult T cell leukemia 8. Concerned about following diseases i) Intracranial bleeding, lung bleeding,and gastrointestinal bleeding ii) Allergy to thrombomodulin-alpha 9. Patient who judged it to be inappropriate

Design outcomes

Primary

Measure	Time frame
Bleeding episords within preparative regimens with using thrombomoduline alfa	—

Secondary

Measure	Time frame
1: Cumirative incidence of engraftment of neutorophile and platelet 2: Incidence of transplant releted toxicty, especially diarrhea within 28 days after transplantation 3: Incidence of TTP/HUS(so called TMA) and Iinfections 4: Incidence and grade of acute GVHD 5: Relapse rate untile 1year after transplantation 6: Overall survival rate untile 1year after transplantation 7 :Adverse event rate	—

Contacts

Public ContactShigesaburo Miyakoshi

Tokyo Metoropolitan Geriatoric Hospital

s-miyakoshi@danc.ocn.ne.jp+81-3-3964-1141

Outcome results

None listed

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