acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndromes (MDS), non-Hodgkin lymphoma (NHL)
Conditions
Sponsors
University of Tsukuba Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Preliminary inclusion criteria 1) Patients with AML (blast < 5%), ALL (blast < 5%), MDS (blast < 5%), or NHL (complete response or partial response) 2) Patients 16 to 65 years of age 3) Patients who do not have HLA antigen-matched (6/6) appropriate related donors 4) Patients who do not have HLA allele-matched (8/8) unrelated donors. 5) Patients with ECOG of 0, 1, or 2 6) Patients without severe dysfunction in the heart, the lung, the liver, and the kidney (a) ejection fraction >= 40% (b) SaO2 (or SpO2) >= 94% (c) %VC >= 70%, and FEV1.0% >= 70% (d) total bilirubin < x1.5 of the upper limit (e) ALT < x3 of the upper limit (f) AST < x3 of the upper limit (g) creatinine < 2.0 mg/dL 7) Patients who gave written informed consent 2. Secondary inclusion criteria 1) SaO2 (or SpO2) >= 94% 2) total bilirubin < x1.5 of the upper limit 3) ALT < x3 of the upper limit 4) AST < x3 of the upper limit 5) creatinine < 2.0 mg/dL
Exclusion criteria
Exclusion criteria: 1. Preliminary exclusion criteria 1) Patients with anti-HLA antibody 2) Patients with uncontrollable psychological complications 3) Patients with active double cancer 4) Patients with uncontrollable active infection 5) Patients with bone marrow fibrosis (reticulin grade >= 2) 6) Patients with prior history of allogeneic hematopoietic transplantation 7) Patients with severe cardiac complications 8) Patient with prior thrombotic history or with predisposing factors to thrombosis 9) Patients with positive for HIV antibody, HBs antigen, or HCV-RNA 10) Patients with uncontrollable diabetes mellitus 11) Patients with uncontrollable hypertension 12) Patients who were enrolled to other clinical trials within 3 months 13) Patients with prior history of TPO-R administration 14) Patients with hypersensitivity to recombinant protein derived from E-coli 15) Pregnant women, patients during lactation, or patients who deny anticonception 16) Patients who are judged inappropriate by investigators 2. Secondary exclusion criteria 1) Patients who are judged inappropriate by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Every adverse event which is related to administration of AMG531 | — |
Secondary
| Measure | Time frame |
|---|---|
| cumulative incidence of cases which achieved platelet >= 50,000 /mcL by day 57 day of neutrophil engraftment day of platelet >= 20,000 /mcL day of platelet >= 50,000 /mcL total amount of transfused platelet units hemorrhagic events thrombotic events fibrosis of the bone marrow disease relapse non-relapse mortality | — |
Countries
Japan
Contacts
Public ContactKurita Naoki
University of Tsukuba Hospital Department of Hematology
Outcome results
None listed