Relapsed Hodgkin Lymphoma Level: PT Classification code 10020266 Term: Recurrent Hodgkin's Disease
Conditions
Interventions
Product Name: Fludarabine
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Fludarabine
CAS Number: 75607-67-9
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A confirmed diagnosis of Hodgkin Lymphoma 2. Relapse following first remission and in complete or partial remission (using standard CT criteria) following salvage therapy (platinum-based), but with residual FDG-avid lesions. 3. HLA matched sibling donor 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 Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Impaired renal function: creatinine clearance 1.5 x upper limit of normal or alkaline phosphatase > 2 x upper limit of normal. 3. Inadequate cardiac function (LVEF < 40%) 4. Symptomatic respiratory compromise 5. Pregnant or lactating women. 6. Previous HDT or allograft 7. Previous malignancy in the past 5 years, except non-melanoma skin tumours or stage 0 (in situ) cervical carcinoma 8. HIV positivity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess progression free survival following reduced intensity allogeneic transplantation in a relatively poor prognostic group of Hodgkin lymphoma patients, and allow comparison with historically expected results for autografting. The primary end point is progression free survival.; Secondary Objective: To record response rates, overall survival, non-relapse mortality, donor engraftment rates and response to donor lymphocyte infusions. To record incidence and severity of GVHD and other significant toxicity. ;Primary end point(s): 3 year Progression Free Survival (PFS) | — |
Countries
United Kingdom
Outcome results
None listed