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)"Subjects
Predictive and prognostic markers |Identifiers
Source Study
Trial acronym
ALLG NHL21
Trial ID
ACTRN12609001077257
Purpose
Treatment
Phase
Phase 2
Funding
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 .... Read more
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 .... Read more
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 .... Read more
Can healthy volunteers participate?
No
Population
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
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) .... Read more
Comparison
Control group Active
Active - PET+ patients recieve R-ICE and Z-BEAM Transplant. whereas the PET- patients will recieve R-CHOP chemotherapy only.
Outcomes
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 .... Read more
Will individual participant data (IPD) for this trial be available?
yes
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