CompletedPhase 2ACTRN12609001077257

A multi-centre phase II trial of early treatment intensification with R-ICE (rituximab – ifosfamide, carboplatin, etoposide) chemotherapy followed by BEAM ( BCNU(BCNU is Carmustine), etoposide, ara-C (ara-C is Cytarabine), melphalan) high dose chemotherapy and autologous stem cell transplantation for patients with poor prognosis diffuse large B-cell lymphoma

This is a multi-centre phase II trial of early treatment intensification with R-ICE (rituximab – ifosfamide, carboplatin, etoposide) chemotherapy followed by BEAM ( BCNU(BCNU is Carmustine), etoposide, ara-C (ara-C is Cytarabine), melphalan) high dose chemotherapy and autologous stem cell transplantation for patients with poor prognosis diffuse large B-cell lymphoma as identified by interim-treatment PET/CT (Positron emission tomography - computed tomography) performed after four cycles of R-CHOP-14 (rituximab and Cyclophosphamide, Doxorubicin, Vincristine, Prednisone - CHOP - every 14 days) chemotherapy.


Sponsor

Australasian Leukaemia and Lymphoma Group (ALLG)

Enrollment

162 participants

Start Date

Jul 20, 2009

Study Type

Interventional

Conditions

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 diffuse large B cell type (DLBCL) have either low intermediate, high intermediate, or high risk disease, or low risk disease with bulky tumour (> 7.5 cm) are considered fit and eligible for high dose chemotherapy(HDCT) and autologous stem cell transplantation (ASCT) have not received previous treatment for lymphoma. Trial details All participants will receive treatment with R-CHOP-14 chemotherapy every fourteen days over four cycles. They will then undergo PET/CT scanning. Participants who have scans that show the disease remains active will have their treatment intensified with R-ICE chemotherapy followed by HDCT with Z-BEAM (a special chemotherapy regimen) and ASCT. If the scans show that the cancer is no longer active, they will receive a further two cycles of the R-CHOP-14 chemotherapy. The study aims to monitor participants to see the effectiveness of this new treatment, particularly in relation to an expected increase in the number of patients who remain disease free after two years.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 70 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests an intensive chemotherapy and stem cell transplant approach for adults aged 18 to 70 with a type of blood cancer called diffuse large B-cell lymphoma that has a poor outlook. It is for newly diagnosed patients who have not yet received treatment. The study aims to see if early intensification of treatment improves outcomes.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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-1

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) plus two doses of rituximab. Patients who display metabolically active disease (PET/CT-positive) will then receive treatment intensification with rituximab, Ifosfamide, Carboplatin and Etoposide (R-ICE) supported by Pegfilgrastim or Filgrastim for 3 cycles at intervals of 21 days. Peripheral blood stem cells will be collected following one of the cycles (typically the second or third) of R ICE. Subsequently, responding patients will undergo High Dose Chemotherapy (HDCT) with Zevalin-BEAM ( Z-BEAM) and autologous stem cell transplantation (ASCT).Dose is based on the individual patient Body Surface Area (BSA) calculation.


Locations(1)

VIC, Australia

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ACTRN12609001077257