High risk hematological malignancies, which require allogeneic stem cell transplantation therapy, without HLA- full match or 1 locus mismatch donors
Conditions
Interventions
HSV-TK gene transduced lymphocyte add-back thrapy after T-cell depleted haplo-identical hematopoietic stem cell transplantation
Sponsors
National Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients satisfying at least one of the following requirements (1) Patients during the first remission of acute myelogenous leukemia. (2) Patients during the second or subsequent remission of acute myelogenous leukemia. (3) Patients with myelodysplastic syndrome, classified as the sub-group predicting poor prognosis (4) Patients with myelodysplastic syndrome dependent on blood transfusion. (5) Patients during the first or subsequent chronic phase of chronic myelogenous leukemia or in its transitional phase (6) Patients during the first remission of high-risk acute lymphocytic leukemia 2) Patients lacking any appropriate donor (both related and unrelated) whose HLA is serologically identical or a single antigen mismatched 3) Patients who don't have any donors to meet the eligibility criteria in the study 4) Patients between 20 and 60 years old, with life expectancy of 9 months or more after hematopoietic stem cell transplantation 5) Patients with ECOG performance status 0 or 1
Exclusion criteria
Exclusion criteria: 1) Patients unlikely to stop the ongoing ganciclovir administration for the presentation of CMV infection or elevated blood CMV antigen level by the start of conditioning regimen. 2) Patients unlikely to stop the ongoing ACV administration by the start of conditioning regimen. 3) Patients whose ejection franction at rest is less than 50% when measured by echocardiography 4) Patients with diabetes mellitus poorly controlled despite continued insulin therapy 5) Patients with poorly controlled hypertension 6) Patients having treatment-requring allergy or allergy to any drugs used during this study 7) Patients with active infection 8) Patients with uncontrollable evident tumor cell invasion into the central nervous system 9) Patients with active double cancers 10) Patients with previous history of TBI or total lymph node irradiation (TLI) 11) Patienta tested positive for any of HIV antibody, HBs antigen and HCV antibody
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of HSV-TK gene transduced donor lymphocyte add-back therapy after T-cell depleted hapo-identical hematopoietic stem cell transplantation. Immue-reconstitution, prvability of GVHD and it's control efficacy after HSV-TK gene transduced donor lymphocyte add-back. | — |
Secondary
| Measure | Time frame |
|---|---|
| Provavility of infection, diasease free survival and overall survival after HSV-TK gene transduced donor lymphocyte add-back therapy afterT-cell depleted haplo-identical stem cell transplanation. | — |
Countries
Japan
Contacts
Public ContactTakuya Yamashita
National Cancer Center Hospital Hematopoietic Stem Cell Transplantaion Division
Outcome results
None listed