None listed
Conditions
Brief summary
The aim of this study is to evaluate the safety and efficacy of a new medication called lipegfilgrastim to reduce a frequent complication of chemoimmunotherapy used to treat Non Hodgkin Lymphoma (NHL). Who is it for? You may be eligible to join this study if you are aged 18 years or older, have a confirmed diagnosis of NHL requiring chemoimmunotherapy, and are at risk of febrile neutropenia. Study details All participants in this study will receive preventive treatment with a drug called lipegfilgrastim. Lipegfilgrastim is a growth factor that stimulates the bone marrow to produce neutrophils, white cells that help fight infection. Lipegfilgrastim is administered via an injection under the skin 24-72 hours after each dose of chemotherapy. Nursing staff will administer the growth factor. In conjuction with your treating haematologist, you will be monitored until approximately 14-21 days you complete your last cycle of chemotherapy. There will also be a follow up phone call 3 months after completing the study. During the study, you will undergo medical consultation, physical examination and regular blood tests (all but one are additional to 'standard of care' for your condition) This trial will produce safety and efficacy data for this preventive treatment and may reduce a complication of NHL chemoimmunotherapy.
Interventions
Lipegfilgrastim is currently approved for primary and secondary prophylaxis of febrile neutropenia world-wide, including Australia. However, there is a paucity of data in the haematological setting, including patients undergoing immuno-chemotherapy for NHL.
We wish to undertake a study of the safety and efficacy of lipegfilgrastim in patients with NHL undergoing immuno-chemotherapy.
To assess the efficacy of lipegfilgrastim, the study will assess the rate of febrile neutropenia (FN) in patent
Lipegfilgrastim is currently approved for primary and secondary prophylaxis of febrile neutropenia world-wide, including Australia. However, there is a paucity of data in the haematological setting, including patients undergoing immuno-chemotherapy for NHL. We wish to undertake a study of the safety and efficacy of lipegfilgrastim in patients with NHL undergoing immuno-chemotherapy. To assess the efficacy of lipegfilgrastim, the study will assess the rate of febrile neutropenia (FN) in patents receiving chemo-immunotherapy (CIT) for Non-Hodgkin Lymphoma (NHL). To assess the safety of the lipegfilgrastim,, adverse events (i.e allergic reactions, bony pain, other side effects and tolerability), will be recorded. Lipegfilgrastim 6mg is administered via subcutaneous injection 24-72 hours post each cycle of chemoimmunotherapy, as per manufacturer's recommendations (based on preclinical and clinical data). The chemoimmunotherapy regimen will depend on the type of lymphoma. For the purposes of this study, lipegfilgrastim will be administered by clinical trial nursing staff. The frequency and duration of the lipegfilgratim will be variable for each participant ie will depend on the prescribed chemoimmunotherapy regimen (ie this variable is not controlled for this trial).
Sponsors
Monash Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Confirmed diagnosis of NHL (new diagnosis or relapsed/refractory) • NHL requiring CIT (subject is allowed to have commenced CIT, but must not have received more than 1 cycle) • Subjects meets EORTC criteria for G-CSF administration: o Prophylactic: Predicted FN risk >20%, or >10% with at least 1 patients associated risk factors for FN as per the EORTC o Secondary: previous history of CIT related FN (including Cycle 1 of current CIT) • Age greater than or equal to 18 years • Subject must have ability to provide written informed consent before any study-specific procedure is performed • Subjects receiving salvage CIT are eligible, but will discontinue trial prior to stem cell harvestation.
Exclusion criteria
• Active infection with Hepatitis B virus or Hepatitis C virus • Known infection with human immunodeficiency virus (HIV) • Active infection (patient must be haemodynamically stable and not on any intravenous antibiotics for at least 48 hours) • Subject is pregnant or breast feeding • Known sensitivity to lipegfiltrastim or other G-CSF products • Subject will not be available for follow-up assessment • Inadequate functional status (ECOG >2) • Grade >3 pain disorder (as per CTCAE 4.03), including osteoarthritis or other bone/muscular pain disorders
Outcome results
None listed