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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

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).

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

Inclusion Criteria10

  • Age 18 - 70 years
  • Male and female patients
  • Diagnosis of CD20-positive diffuse large B-cell lymphoma on biopsy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
  • Low-intermediate, high-intermediate, high risk, or low risk disease with bulk (>7.5 cm)
  • 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 chemotherapy with Z-BEAM and autologous stem-cell transplantation
  • Signed informed consent form
  • A positive baseline fluorodeoxyglucose(FDG) positron emission tomography(PET)

Exclusion Criteria18

  • Life-expectancy < 3 months
  • Transformed NonHodgkin lymphoma (NHL) or types of NHL other than DLBCL
  • Primary Central Nervous System (CNS) or gastrointestinal Mucosa-Associated Lymphoid Tissue (MALT)lymphoma
  • CD20-negative NHL
  • Documented Human Immunodeficiency Viris (HIV)
  • 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 vaccination
  • Patients with good prognosis low risk disease (IPI = 0, 1) plus absence of bulk (= 7.5 cm).
  • Hypersensitivity to components of Zevalin including ibritumomab tiuxetan, Yttrium chloride, other murine proteins, or to any exipients
  • Pregnant woman
  • Previously treated lymphoma
  • Any serious active disease or co-morbid medical condition (according to investigator’s decision)
  • Non-compensated cardiac failure
  • Chronic lung disease with hypoxaemia
  • Severe psychiatric disease
  • Poor renal function (creatinine > 150 micromol/L), poor hepatic function (total bilirubin level > 30 mmol/L, transaminases > 2.5 maximum normal level) unless abnormalities are related to the lymphoma
  • Poor bone marrow reserve as defined by neutrophils < 1.5 x 109/L or platelets < 100 x 109/L, unless related to bone marrow infiltration
  • Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumours or stage 0 (in situ) cervical carcinoma
  • Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study

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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