Phase II Study of Reduced Intensity Allogeneic Transplantation for Refractory Hodgkin Lymphoma - Pilot of Allogeneic Immunotherapy in Refractory Disease (PAIReD)

Phase 1

• Conditions: Refractory Hodgkin Lymphoma; MedDRA version: 18.0Level: PTClassification code 10020267Term: Hodgkin's disease refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 18.0Level: PTClassification code 10020266Term: Hodgkin's disease recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2008-004956-60-GB
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-06-12
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 32

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:
3.1.Primary refractory HL achieving 3.2.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

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

Exclusion Criteria

1.Progressive disease
2.Complete response
3.Previous HDT or allograft
4.Impaired renal function: creatinine clearance < 50 mls/min
5.Impaired hepatic function: serum bilirubin >1.5x upper limit of normal or alkaline phosphatase >2x normal
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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess progression free survival after reduced intensity allogeneic transplantation in a poor prognostic group of patients with Hodgkin lymphoma with persistent disease after treatment (either primary refractory or relapsed refractory disease). ;Secondary Objective: To record response rates, overall survival, non-relapse mortality, donor engraftment rates and response to donor lymphocyte infusions.<br>To record the incidence and severity of GVHD and other significant toxicity.;Primary end point(s): 3 year progression free survival (PFS)