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NB: The information displayed below does not replace the protocol. The latest protocol version should always be consulted before making clinical decisions.
PAIRed

PAIReD (Pilot of Allogenic Immunotherapy in Refractory Disease): Phase II study of reduced intensity allogeneic transplantation for refractory Hodgkin lymphoma

Specialty
Cancer
Portfolio Eligibility
Automatically eligible
ISRCTN
EudraCT 2008-004956-60
MREC N° 09/H0804/74
UKCRN ID 6284
WHO ID
Research Summary
Single arm trial of RIC allografting in patients with relapsed/refractory Hodgkin's lymphoma who are chemo-sensitive but remain PET positive with salvage therapy. BEAM-alemtuzumab conditioning will be used and the trial will assess faesibility, toxicity and survival.
Study Type Interventional
Design Type Treatment
Disease(s) Lymphoma (Hodgkin's)
Phase II
Current Status Closed - in follow-up
Closure Date 2/13/2014
Global Sample Size 32
Global Recruitment to Date
106%
Geographical Scope UK Multi-Centre
Lead Country England (also active in Scotland)
Health care professionals can obtain a copy of the protocol by clicking here
Study Website
Additional Information

If you are a patient or relative this link will take you to a description of the trial in plain English on CancerHelp UK.

Main 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 16-65 years
5. WHO performance status grade 0-1
6. Written informed consent
7. No concurrent serious medical condition that would preclude an allograft
Main Exclusion Criteria
1. Progressive disease
2. Complete response after two cycles of salvage chemotherapy
3. Previous HDT or allograft
4. Impaired renal function: creatinine clearance < 50 mls/min (as measured by EDTA clearance or 24 hour urine collection)
5. Impaired hepatic function: serum bilirubin >1.5x upper limit of normal (ULN) or alkaline phosphatase >2x ULN
6. Inadequate cardiac function (LVEF <40%)
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
Chief Investigator(s)
Dr Karl Peggs
Further details, please contact
Dr Nadjet El-Mehidi

CR UK & UCL Cancer Trials Centre
CR UK & UCL Cancer Trials Centre
90 Tottenham Court Road
London
W1T 4TJ
UNITED KINGDOM

Tel: 02076799283 Ext: 09283
Fax: 0207 679 9861
n.el-mehidi@ucl.ac.uk
Mrs Lisa Lowry

Abbott Laboratories Limited


Tel: 01131234567
ll@ctc.ucl.ac.uk
Funder(s) Cancer Research UK
Sponsor(s)




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