EUCTR2005-001925-27-GB
Active, not recruiting
Phase 1
Phase I/II clinical trial of T cell suicide gene therapy following haploidentical stem cell transplantation
Great Ormond Street Hospital For Children NHS Trust0 sites10 target enrollmentJune 10, 2009
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Great Ormond Street Hospital For Children NHS Trust
- Enrollment
- 10
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Patients with primary immunodeficiencies or haematological malignancies at GOSH (children aged upto 16 years) undergoing haplo identical transplant
- •2\.Both patient and donor must give informed consent in writing.
- •3\.The donor must be willing, able and available for donation of T cells by collection of whole blood or leucapheresis.
- •4\.The patient should be free of serious intercurrent illness.
- •5\.Female patients of child\-bearing age must have a negative pregnancy test, and agree to use reliable contraceptive methods for the duration of the therapy.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
Exclusion Criteria
- •1\.Donor unfit or unavailable
- •2\.Donor positive for hepatitis b or c, or htlv\-1, or hiv
- •3\.Patient receiving Ganciclovir, Aciclovir, Cidofovir a result of active CMV, varicella zoster, adenovirus or herpes simplex infection infection
- •4\.gvhd \> grade ii before infusion of gm\-t cells
- •5\.serious intercurrent illness
- •6\.Positive pregnancy test or reluctance to use contraception
Outcomes
Primary Outcomes
Not specified
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