hematological dieseases hematological diseases, leukemia, myelodysplastic syndrome, lymphoma, aplastic anemia
Conditions
Interventions
Administration of Enalmon Depot 250 mg intramuscularly every 4 weeks.
The study drug will be administered 28-42 days after allogeneic hematopoietic stem cell transplantation and continued every 4 week
D013739
testosterone
Sponsors
Sakata Mamiko
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Preliminary inclusion criteria 1) Patients undergoing allogeneic hematopoietic stem cell transplantation for hematological diseases 2) Male Patients >= 18 years old at the time of consent 3) Patients who gave informed consent Secondary inclusion criteria 1) Patients who had received allogeneic hematopoietic stem cell transplantation for hematopoietic diseases 2) Patients who achieved neutrophil engraftment 3) AMS score >= 27 points
Exclusion criteria
Exclusion criteria: 1) Patients with relapse or residual diseases after allogeneic hematopoietic stem cell transplantation 2) Patients with androgen-dependent tumors (PSA > 2.0 ng/mL) 3) Patients with sleep apnea syndrome 4) Patients who wish to have a baby and are not undergoing sperm preservation 5) Patients with severe bleeding tendency due to thrombocytopenia or coagulopathy. 6) Patients with ECOG PS 4 7) Patients with uncontrolled graft-versus-host disease 8) Patients with uncontrolled infections 9) Patients with uncontrolled diabetes 10) Patients receiving treatment for depression and patients with other uncontrolled psychiatric disorders 11) Patients with left ventricular ejection fraction = 100 U/L or T-Bil >= 2.0 mg/dL) 14) Patients with severe renal disease (serum creatinine >= 2.0 mg/dL) 15) Patients who have received other investigational drugs within 3 months prior to this study 16) Patients deemed inappropriate by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Every adverse event which is related to administration of testosterone | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Body composition by DEXA 2) Body composition by bio-impedance method 3) Vital signs (blood pressure, pulse rate) 4) Grip strength 5) ABI 6) Quality of life assessment (SF-36, FACT-BMT, AMS score, IPSS, EHS) 7) Blood count, biochemistry, electrolytes, hormone, lipids, glucose metabolism, bone metabolism markers, PSA | — |
Contacts
Public ContactNaoki Kurita
University of Tsukuba Hospital
Outcome results
None listed