Trial Details
Trial status:
In follow-up (non-recruiting)
Recruitment start date:
01/09/2009
Funder:
Chugai Pharma UK Ltd
Sponsor:
UCL
Chief Investigator:
Dr. Karl Peggs
Recruitment target:
47
EudraCT number:
2008-004956-60
Contact details:
ctc.paired@ucl.ac.uk
Lay summary:
PAIReD
Phase II study of reduced intensity allogeneic transplantation for refractory Hodgkin lymphoma
Description
Design: PAIReD is a multicentre phase II single-arm trial of BEAM-Campath conditioned reduced intensity stem cell transplantation for patients with relapsed or refractory Hodgkin lymphoma.
Treatment: All patients registered and PET positive (Deauville score 3-5) on central PET-CT scan review had a BEAM-Campath (carmustine, etoposide, cytarabine, melphalan, alemtuzumab) conditioned reduced intensity stem cell transplant from a sibling or unrelated stem cell donor. Patients were followed up with regular PET-CT scans, and donor lymphocyte infusion (DLI) was given if the patient was found to have become PET positive. DLI was also given for mixed chimerism or stable residual disease after transplant.
Key inclusion/exclusion criteria:
Patient Inclusion Criteria
1. A confirmed diagnosis of Hodgkin Lymphoma
2. HLA-compatible sibling or unrelated donor (at least 9/10 match)
3. Two subgroups of patients will be included in the study:
a. Primary refractory HL achieving
b. HL in first relapse achieving
4. Age 11-65 years
5. WHO performance status grade 0-1
6. Written informed consent
7. No concurrent serious medical condition that would preclude an allograft

Patient Exclusion Criteria
1. Progressive disease
2. Complete response after 2 cycles of salvage chemotherapy
3. Previous HDT or allograft
4. Impaired renal function: creatinine clearance
5. Impaired hepatic function: serum bilirubin >1.5x upper limit of normal (ULN) or alkaline phosphatase >2x ULN
6. Inadequate cardiac function (LVEF
7. Symptomatic respiratory compromise
8. Pregnant or lactating women
9. Previous malignancy in the past 5 years, except non-melanoma skin tumours or stage 0 (in situ) cervical carcinoma
10. HIV positivity
Duration of recruitment: 45 months 
Aim
The PAIReD trial aimed to test the feasibility, safety and effect on progression-free survival of reduced intensity allogeneic stem cell transplantation in patients with primary refractory or relapsed Hodgkin lymphoma using BEAM-Campath conditioning. The study also tests the feasibility of using regular PET-CT scanning after transplant to detect early signs of relapse, and triggering the use of donor lymphocyte infusion to prevent disease relapse.
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.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
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Telephone:
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020 7679 9899
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