Suicide Gene Therapy for Donor Lymphocytes Infusion After Allogeneic Hematopoietic Stem Cell Transplantation: a Phase I/II Clinical Study
18 Years
70 Years
Both
Hematological Malignancy
Trial Information
Suicide Gene Therapy for Donor Lymphocytes Infusion After Allogeneic Hematopoietic Stem Cell Transplantation: a Phase I/II Clinical Study
DLI-TK is administered either after failure of 1 or several previous standard (std-) DLI of,
defined after a minimal follow-up of 2 months after the last injection. To prepare DLI-TK,
donor T-cells are transduced with a retroviral vector encoding TK. Transduced cells are
selected using a CliniMACS device (MYLTENYI). In case of previous std-DLI received, the
DLI-TK cell dose is adjusted to be below or equal to the maximal cell dose previously
received in std-DLI. No comparison is planned in the analysis.
Inclusion Criteria:
- Hematological malignancy.
- Previous allogeneic hematopoietic stem cell transplantation.
- Relapse diagnosed at the molecular, cytogenetic, or cytological level.
- Failure of a previous stdILD or inclusion in first intention without previous stdDLI.
- Age > 18 years and < 70 years at the time of inclusion. For patients between 15 and
18 years of age, a case-per case inclusion will be studied.
- Performance status considered on the score Eastern Cooperative Oncology Group (ECOG)
< 2.
- Life expectation 1-month-old superior.
- Signed written informed consent.
- Negative human chorionic gonadotropin (HCG) in the 7 days preceding the inclusion for
women in age of procreation.
- Membership of the French national insurance.
Exclusion Criteria:
- Grade >II acute GVHD or chronic extensive GVHD at the time of inclusion.
- Patient receiving an immunosuppressive treatment for GVHD treatment at the time of
inclusion.
- Dysfunction of liver (alanine aminotransferase / aspartate transaminase (ALAT/ASAT) >
5 N, or bilirubin > 50 µM), or of the renal function (creatinine clearance < 30 ml /
min).
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Incidence of "severe" GHVD (acute grade >II or chronic extensive) following DLI-TK and treatment with GCV
Outcome Description:
Incidence of "severe" GHVD (acute grade >II or chronic extensive) following DLI-TK and treatment with GCV
Outcome Time Frame:
during the 12 months of follow-up
Safety Issue:
Yes
Principal Investigator
Sébastien Maury, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Assistance Publique - Hôpitaux de Paris
Authority:
France: Ministry of Health
Study ID:
P010506
NCT ID:
NCT01086735
Start Date:
February 2010
Completion Date:
November 2012
Related Keywords:
- Hematological Malignancy
- hematological malignancy
- allogeneic hematopoietic stem cell transplantation
- donor lymphocyte infusion
- antitumor immunotherapy
- graft-versus-tumor effect
- gene therapy
- relapse
- adult
- Neoplasms
- Suicide
- Hematologic Neoplasms
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