Trial Details
Trial status:
Active (recruiting)
Recruitment start date:
01/03/2013
Funder:
Bloodwise
Sponsor:
UCL
Chief Investigator:
Kavita Raj
Recruitment target:
78
EudraCT number:
2011-005889-38
Contact details:
ctc.uk-haplo@ucl.ac.uk
Lay summary:
UK-Haplo
UK-Haplo: A UK multicentre phase II study of haploidentical stem cell transplantation in patients with haematological malignancies
Description
Design: UK Haplo is a multicentre, non-randomised Phase II trial in patients with haematological malignancies to investigate whether it is possible to carry out haploidentical peripheral blood stem cell transplantation using high dose cyclophosphamide safely and effectively. Patients can be registered to have a transplant with either a myeloablative conditioned (MAC) or reduced intensity conditioned (RIC) haploidentical stem cell transplant. Treatment allocation is at the investigator’s discretion based on the patient’s age, medical history, physical fitness and personal preference. 
Treatment: Patients on the MAC pathway receive high dose total body irradiation, donor lymphocyte infusion and high dose cyclophosphamide prior to stem cell infusion. Patients on the RIC pathway receive fludarabine, low dose cyclophosphamide and low dose total body irradiation prior to stem cell infusion, with high dose cyclophosphamide given post-transplant. Patients are followed up for 2 years in the first instance and annual thereafter until the end of the trial
Key inclusion/exclusion criteria: Patients must be aged 16-70 with a haematological malignancy, have had chemotherapy within 3 months and require an allogeneic stem cell transplant in line with current UK transplant guidelines. They cannot have had an allogeneic transplant within the previous 3 months or have graft rejection following a previous transplant. Patients must have a haploidentical donor (5/10 – 9/10 match) available and cannot have a matched sibling or unrelated donor. They must be fit for transplant with adequate liver, kidney, heart and lung function and cannot have severe comorbidities, uncontrolled infection, or be pregnant or breastfeeding.
Duration of recruitment: 4 years
Aim
The overall aim of the UK Haplo trial is to investigate the safety and efficacy of haploidentical allogenic peripheral blood stem cell transplants in haematological malignancies using high dose cyclophosphamide. The study will investigate the effect on overall and progression free survival, engraftment and graft failure rates and complications of transplant including graft versus host disease (GVHD) and infection.
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
NameVersionCurrent versRelease dateDownload
UK Haplo Protocol v4.1 01.11.2016v4.1 Current 01/11/2016
Trial documents
No documents have been currently made available for download
Contact Us
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