ALLG NHL21
ACTRN12609001077257
Treatment
Phase 2
Other Collaborative groups,Australasian Leukaemia and Lymphoma Group (ALLG)
Associate Professor Mark Hertzberg
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
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
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
No
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) .... Read more
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 .... Read more
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