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

Phase 2

Recruiting

• Conditions: Hematological disease with stem cell transplant adaptation; acute myeloid leukemia myelodysplastic syndrome

• Registration Number: JPRN-jRCTs031190075
• Lead Sponsor: Miyakoshi Shigesaburo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bleeding episords within preparative regimens with using thrombomoduline alfa

Secondary Outcome Measures

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