chronic myeloid leukemia, acute myeloid leukemia, acute lymphoid leukemia, myelodysplastic syndrome malignant lymphoma
Conditions
Interventions
Intrabone marrow injection of bone marrow cells
Sponsors
Hyogo College of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who have a related HLA-identical or HLA-haploidentical donor are eligible. When patients lack an availble unrelated donor who is identical in HLA-A, -B, and -DR antigens, with 0-1 locus mismatch in allele type, HLA-haploidentical donor can be selected. Patients who urgently need transplantation are eligible. 2. Disease and status a) Chronic myeloid leukemia 1) Second or later chronic state, accelerated phase, or blast crisis 2) Percentage of blast cells in the bone marrow should be < 30% b) Acute myeloid leukemia 1) Patients who have disease status other than first complete remission, or patients who have a high risk of chromosomal abnormalities, who have transformed disease from myelodysplastic syndrome, or who needed 2 or more round of induction chemotherapy for achieving complete remission are eligible. 2) Percentage of blast cells in the bone marrow should be < 30% c) Acute lymphoid leukemia 1) Patients who have status other than first complete remission, or patients who have Philadelphia chromosome, or MLL gene abnormalities or who needed 2 or more round of induction chemotherapy for achieving complete remission are eligible. 2) Percentage of blast cells in the bone marrow should be < 30% d) Myelodysplastic syndrome, Myelodysplasia/ myeloproliferative disease 1) Intermediate-II or high in International Prognostic Factor Scoring System, or relapse e) Malignant lymphoma 1) Low grade lymphoma: chemorefractory 2) Intermediate risk lymphoma: chemorefractory 3) high grade lymphoma: status other than first complete remission
Exclusion criteria
Exclusion criteria: 1. Performance status: 2 or more in ECOG criteria 2. AST, ALT > 5 x normal limit 3. serum bilirubin level > 2.0 mg/dl 4. serum creatinine level > 2.0 mg/dl 5. SaO2 < 90% 6. Ejection fraction < 50% 7. HBs antigen(+), HIV antibody(+) 8. Active infection 9. presence of myelofibrosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint in the phase I study is the safety of intrabone marrow transplantation transplantation, and primary endpoint of the phase II study is donor-derived engraftment on day 35. | — |
Countries
Japan
Contacts
Public ContactToshihiro Soma
Hyogo College of Medicine Division of Hematology, Department of Internal Medicine
Outcome results
None listed