"Add-back" therapy with HSV-TK gene transduced donor lymphocytes after T-cell-depleted haplo-identical hematopoietic stem cell transplantation

UMIN ID: UMIN000002502

Registered date:17/09/2009

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: High risk hematological malignancies, which require allogeneic stem cell transplantation therapy, without HLA- full match or 1 locus mismatch donors
• Date of first enrollment: 2009/10/01
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): HSV-TK gene transduced lymphocyte add-back thrapy after T-cell depleted haplo-identical hematopoietic stem cell transplantation

Outcome(s)

• Primary Outcome: 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 Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 60years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: National Cancer Center Hospital
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare