None listed
Conditions
Brief summary
Study Overview This study aims to evaluate the safety of a 90-minute Obinutuzumab infusion in patients with Chronic Lymphocytic Leukemia (CLL) or Follicular Lymphoma (FL). Eligibility You may qualify for this study if you are 18 years or older, have Chronic Lymphocytic Leukaemia (CLL) or Follicular Lymphoma (FL) and are receiving treatment with Obinutuzumab at Cairns Hospital. Study Details After the first cycle, participants will receive a 90-minute Obinutuzumab infusion on Day 1 of each 21, 28, or 56-day cycle of treatment, continuing until disease progression or unacceptable adverse events occur. Alternatively, patients may choose to continue with the standard 6-hour infusion which is the current standard of care. As part of the study, patients will be closely monitored for infusion reactions will be assessed at each session. Benefits? This study hopes to improve patient's experience getting treatment with Obinutuzumab by reducing the time burden in chair to receive essential treatment.
Interventions
CYCLE 1- DAY 1
FL: Day 1: 1000mg dose, commence at 50mg/hr, increment by 50mg/hr every 30 mins (max400mg/hr)
CLL: Day 1: 100mg dose at 25mg/hr followed by
Day 2: 900mg dose, commence at 50mg/hr, increment by 50mg/hr every 30 mins (max 400mg/hr
CYCLE 1- DAY 8
FL & CLL: 1000mg dose, commence at 100mg/hr, increment by 100mg/hr every 30mins (max 400mg/hr)
CYCLE 1- DAY 15
FL & CLL 1000mg dose, commence at 100mg/hr, increment by 100mg/hr every 30 mins (max 400mg/hr)
CYCLE 2 onwards
Standard in
CYCLE 1- DAY 1 FL: Day 1: 1000mg dose, commence at 50mg/hr, increment by 50mg/hr every 30 mins (max400mg/hr) CLL: Day 1: 100mg dose at 25mg/hr followed by Day 2: 900mg dose, commence at 50mg/hr, increment by 50mg/hr every 30 mins (max 400mg/hr CYCLE 1- DAY 8 FL & CLL: 1000mg dose, commence at 100mg/hr, increment by 100mg/hr every 30mins (max 400mg/hr) CYCLE 1- DAY 15 FL & CLL 1000mg dose, commence at 100mg/hr, increment by 100mg/hr every 30 mins (max 400mg/hr) CYCLE 2 onwards Standard infusion protocol -If patient experiences any grade 3 or 4 IRR during cycle 1 (or does not consent) Commence at 100mg/hr, incrementing by 100mg/hr every 30 minutes (max 400mg/hr) (4-hour infusion time) Rapid Infusion Protocol 90mins (intervention arm) from cycle 2 onwards If maximum of grade 2 reaction during cycle 1 Fixed rate – 90 minutes (666mg/hr) Treatment cycles vary in length according to chemotherapy backbone. O-CHOP21, O-CVP = 21 day cycle with Obinutuzumab given on Day 1 of the cycle O-acalabrutinb, O-Venetoclax, O-Chlorambucil, O-Bendamustine= 28 day cycle with Obinutuzumab given on Day 1 of the cycle Obinutuzumab maintenance = 56 day cycle with Obinutuzumab given on Day 1 of the cycle CLL patients will be treated for 6 cycles with Obinutuzumab FL patients will be treated for 6 cycles then proceed onto maintenance for 2 years.
Sponsors
Cairns Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients treated with Obinutuzumab for CLL or FL within Cairns Hospital Must score 2 or below on the Eastern Cooperative Oncology Group (ECOG) assessment Maximum of grade 2 or below previous infusion reaction
Exclusion criteria
Patients that have had above grade 2 infusion reaction to obinutuzumab Patients unable to give consent on their own will
Outcome results
None listed