Early treatment intensification with R-ICE and 90Y-ibritumomab tiuxetan (Zevalin)-BEAM stem cell transplantation in patients with high risk diffuse large B-cell lymphoma and positive interim PET after 4 cycles of R-CHOP-14. (NHL21)

Australasian Leukaemia and Lymphoma Group (ALLG)

Dataset description

"Dataset includes: - Full data of 149 patients with a poor prognosis of diffuse large b-cell lymphoma was analysed (151 eligible patients - 3 patients withdrawing consent) - Safety population analyzed was 151 patients (all patients that received at least 1 dose) - ECOG performance status was assessed for all 151 patients (ECOG taken pre-treatment) - Objective to demonstrated effectiveness of using PET/CT scanning to determine further treatment post 4 cycles of R-CHOP-14 treatment ○ PET/CT positive patients receiving R-ICE x 3 followed by Z-BEAM/ASCT + IF-RT ○ PET/CT negative patients recevigin R_CHOP-14 x 2 - Interim PET response of 143 patients (after 4 cycles of R-CHOP 14 - Data of Follow Up of 143 patients went for a minimum length of 0.065 months, and a maximum length of 65.22 (as months since interim PET scan)"
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Source Study


Other Collaborative groups,Australasian Leukaemia and Lymphoma Group (ALLG)

Scientific enquiries

Associate Professor Mark Hertzberg

Brief Summary

This study looks at the effectiveness of early treatment intensification with R-ICE chemotherapy followed by high dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT) if positive PET/CT, or a further 2 cycles of R-CHOP-14 if negative PET/CT in patients with lymphoma which is classified as CD20 positive diffuse large B cell type who have received an initial 4 cycles of R-CHOP-14 chemotherapy. Who is it for? You can join this study if you: have lymphoma which is CD20 positive d ....
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Key Inclusion Criteria

Inclusion criteria 1. Age 18 - 70 years 2. Male and female patients 3. Diagnosis of CD20-positive diffuse large B-cell lymphoma on biopsy 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 5. Low-intermediate, high-intermediate, high risk, or low risk disease with bulk (>7.5 cm) 6. Previously untreated (except for corticosteroids if required) Patients considered suitable for dose-intense chemotherapy with R-CHOP-14 with Pegfilgrastim support Eligible and fit for high dose che ....
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Key Exclusion Criteria

Exclusion criteria 1. Life-expectancy < 3 months 2. Transformed NonHodgkin lymphoma (NHL) or types of NHL other than DLBCL 3. Primary Central Nervous System (CNS) or gastrointestinal Mucosa-Associated Lymphoid Tissue (MALT)lymphoma 4. CD20-negative NHL 5. Documented Human Immunodeficiency Viris (HIV) 6. Seropositivity for Hepatitis B [Either 1. HbsAg (surface antigen) positive or 2. HbcAb (core antibody) positive and HbsAb (surface antibody) titre of < 100 iu/ml] unless clearly due to vaccinatio ....
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Can healthy volunteers participate?




Sample Size    162

Min. age    18 Years

Max. age    70 Years

Sex    Both males and females

Condition category    Patients with CD20+ diffuse large B cell lymphoma (DLBCL) with low intermediate, high intermediate, or high risk disease or low risk disease with bulky tumour (> 7.5 cm) who are considered fit and eligible for high dose chemotherapy (HDCT) with Z-BEAM ( Zevalin - BEAM ( BCNU(BCNU is Carmustine), etoposide, ara-C (ara-C is Cytarabine), melphalan) and autologous stem cell transplantation (ASCT).

Condition code    Cancer


Intervention code Treatment: Drugs , Treatment: Other

Patients will receive 4 cycles of R-CHOP (rituximab Cyclophosphamide, Doxorubicin, Vincristine, Prednisone administered every 14 days (R-CHOP-14) and supported with Pegfilgrastim. Cycle 5 of R-CHOP-14 will be delayed one week, and an interim PET/CT scan will be performed as close as possible (ie, day 17 to day 20) to the planned 5th cycle of R CHOP-14. Patients who have metabolically inactive disease (PET/CT-negative) will proceed to complete a further two cycles of R-CHOP-14 (total of 6 cycles) ....
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Control group Active

Active - PET+ patients recieve R-ICE and Z-BEAM Transplant. whereas the PET- patients will recieve R-CHOP chemotherapy only.


Outcome: Primary objective and endpoint: The primary objective is to demonstrate an absolute improvement of 25% in two-year progression-free survival (PFS) from 20% to 45% in those patients with advanced stage DLBCL who have been identified with a positive interim-treatment PET/CT scan and switched to early treatment intensification using R-ICE chemotherapy followed by HDCT/ASCT in comparison with historical outcomes. The primary endpoint for this trial is progression-free surv ....
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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