Phase I/II clinical trial of T cell suicide gene therapy following haploidentical stem cell transplantatio

Phase 1

• Conditions: Graft-versus-host disease (GVHD) resulting from haploidentical bone marrow or blood stem cell transplantation; MedDRA version: 9.1Level: LLTClassification code 10018651Term: Graft versus host disease

• Registration Number: EUCTR2005-001925-27-GB
• Lead Sponsor: Great Ormond Street Hospital For Children NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-06-10
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

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
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified