Moxetumomab Pasudotox in Relapsed/Refractory Hairy Cell Leukaemia
Research type
Research Study
Full title
A Pivotal Multicenter Trial of Moxetumomab Pasudotox in Relapsed/Refractory Hairy Cell Leukemia
IRAS ID
169194
Contact name
Claire Dearden
Contact email
Sponsor organisation
MedImmune, LLC
Eudract number
2014-003233-26
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
115709, IND number
Duration of Study in the UK
2 years, 11 months, 22 days
Research summary
This study will investigate if the medicine moxetumomab pasudotox is safe and effective in treating Hairy Cell Leukaemia (HCL) that has returned or has not responded to treatment. 77 participants aged 18 years or older will take part in this study across Europe, North America and the Middle East.
HCL is a blood cancer that affects a specific type of white blood cell called a B-lymphocyte (B cells). The bone marrow is the ‘factory’ that makes all types of blood cells. With HCL, the bone marrow makes too many of these abnormal B cells that don't work properly. If the abnormal cells accumulate in the marrow they can stop it from working properly. This clogging of the marrow can lead to shortages of healthy red blood cells, white blood cells and platelets. Symptoms of HCL include tiredness, weakness, suffering from weight loss and prone to frequent infections. Treatments are available for HCL sufferers that are effective but not all respond. Even if a patient’s HCL is successfully treated, HCL can return and these treatments are less effective in this case. Additional treatment options would be of benefit to patients who have relapsed or who do not respond to treatment.
Eligible patients must have undergone at least two prior courses of treatment for HCL. At a minimum, one of these treatments must have been a course of medication of the purine nucleoside analogs class (for example, pentostatin or cladribine).
Enrolled participants will enter into a 24-week treatment phase where they will receive 3 doses of the medication moxetumomab pasudotox per cycle, for a maximum of 6 cycles – each cycle lasting 4 weeks. Per cycle, participants will be required to attend the study centre 7 times. Following the treatment phase, participants will return to the clinic periodically to have their health checked.REC name
London - Westminster Research Ethics Committee
REC reference
15/LO/0288
Date of REC Opinion
13 Apr 2015
REC opinion
Further Information Favourable Opinion