A study of the use of allodepleted donor T cells to improve immunity after unrelated donor stem cell transplant

Phase 1

• Conditions: acute myeloid or acute lymphoblastic leukaemia; MedDRA version: 16.1Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 16.1Level: LLTClassification code 10000844Term: Acute lymphoblastic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-000872-14-GB
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-29
• Last Update Posted: 13 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Patient inclusion criteria:
1. Age =16 years
2. Underlying acute myeloid or acute lymphoblastic leukaemia
3. Planned allogeneic peripheral blood stem cell transplantation from a 9/10 or 10/10 HLA-matched unrelated donor, using an Alemtuzumab-based conditioning protocol
4. Written Informed consent

Donor inclusion criteria:
1. Donors must be unrelated to and HLA-matched (10/10) or a single antigenic/allelic mismatch with the recipient (9/10)
2. Donors must be healthy and pass a medical examination determining they are fit to donate peripheral blood stem cells
3. Donors must sign an informed consent form indicating that they are aware their additional donation of peripheral blood or leucapheresis is for research purposes

Are the trial subjects under 18? yes
Number of subjects for this age range: 4
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Patient exclusion criteria:
1.Life expectancy < 6 weeks
2. Female patients who are pregnant and lactating
3. Patients who are serologically positive for Hepatitis B, C or HIV pre-SCT

Donor exclusion criteria:
1. Donor registry determines contraindication to donate mobilised peripheral blood stem cells, 500ml peripheral blood draw or unstimulated leucapheresis for generation of PBMC.

Study & Design

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