A Phase II Study of Ibrutinib, Rituximab and mini-CHOP therapy in very elderly patients with newly diagnosed DLBCL (NHL29)

Australasian Leukaemia and Lymphoma Group (ALLG)

Dataset description

Dataset includes: Data for 80 patients aged >75 years Treatment of Elderly patient cohort with newly diagnosed Diffuse large B cell lymphoma (DLBCL) with Ibrutinib, Rituximab and mini-CHOP therapy Demographic data, diagnostic data, treatment data, outcome data
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Chemotherapy |

Source Study




Phase 2


Commercial sector/Industry,Janssen-Cilag Pty Ltd

Scientific enquiries

Prof Judith Trotman

Brief Summary

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 ....
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Key Inclusion Criteria

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 ....
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Key Exclusion Criteria

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 ....
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Can healthy volunteers participate?




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 ....
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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.

Study Protocol: Study protocol
Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?


What data in particular will be shared?

De-identified IPD data, for all data collected during the trial

When will data be available?

Data available 3 months following publication, for an indefinite period

Available to whom?

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.

Available for what types of analyses?

Any type of analysis Assessed on a case-by-case basis

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see