IRiC study: Ibrutinib R-mini-CHOP in elderly DLBCL
ACTRN12615000551594
Treatment
Phase 2
Commercial sector/Industry,Janssen-Cilag Pty Ltd
Prof Judith Trotman
The study will evaluate the deliverability and efficacy of Ibrutinib-R-mini-CHOP chemotherapy in elderly patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL). Who is it for? You may be eligible to join this study if you are aged 75 years or above and have been newly diagnosed with DLBCL for which you have received no prior treatment (excluding prednisone). Study details All participants in this study will be treated with a chemotherapy regime known as Ibrutinib-R-mini-CHOP. This w .... Read more
1. Subject must be 75 years of age or older 2. No prior treatment for DLBCL excluding prednisone 3. Histologically confirmed de novo CD20+ DLBCL 4. Stage I bulky (largest dimension of lesion >/= 6cm), II, III or IV disease by the Ann Arbor Classification 5. At least 1 measurable site of disease according to the 2014 Recommendations for Initial Evaluation, Staging and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma – the Lugano Classification. The site of disease must be greater than 1.5 .... Read more
1. History of treated lymphoma of any subtype 2. CNS or meningeal involvement 3. Contraindication to any drug in the chemotherapy regimen 4. Serious active co-morbid disease according to the investigator’s decision 5. Poor renal function, defined as a Creatinine Clearance Rate (as measured by Cockcroft Gault) < 40 mL/min/1.73m2 6. Poor hepatic function, defined as Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 3 x upper limit of normal (ULN) and/or total bilirubin > 1.5 x .... Read more
No
Sample Size 80
Min. age 75 Years
Max. age No limit
Sex Both males and females
Condition category elderly DLBCL
Condition code Cancer
Intervention code Treatment: Drugs
Pre-phase prednisone at a dose of either 40mg/m2 IV or 100mg orally (depending on drug available IV or oral) daily for 5-7 days will be mandatory. All subjects will receive ibrutinib 560mg orally daily, rituximab 375mg/m2 IV (rounded up as per local investigator discretion to the nearest 100mg) on day 1, cyclophosphamide 400mg/m2 IV day 1, doxorubicin 25mg/m2 IV day 1, vincristine 1mg IV and prednisone 40mg/m2 IV or 100mg orally daily on a 21 day schedule aiming for a total of 6 cycles. This wil .... Read more
Control group Uncontrolled
Single arm study
Outcome: The primary objective of this study is to assess the safety of ibrutinib-R-mini-CHOP in subjects with DLBCL as measured by deliverability. Timepoint: Deliverability of Ibrutinib-R-mini-CHOP as measured by: Average Relative Total Dose (ARTD), and Average Relative Dose Intensity (ARDI) Hyrniuk’s model RDI = Total Dose Delivered/Total Time (DDI) / SDI for each cycle and for the total of 8 cycles.
Outcome: The primary objective of this study is to assess the efficacy of ibrutinib-R-mini-CHOP in subjects with DLBCL as measured by overall survival.Timepoint: Overall survival (OS) at 2 years.
yes
De-identified IPD data, for all data collected during the trial
Data available 3 months following publication, for an indefinite period
Data are potentially available to: • Researchers from not-for-profit organisations • Commercial organisations • Other Based in: • Any location Further information: All data requests will be considered by the primary sponsor on a case by case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted.
Any type of analysis Assessed on a case-by-case basis