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NCT Number: NCT00558220

R-MegaCHOP-ESHAP-BEAM in Patients With High-Risk Aggressive B-Cell Lymphomas

The purpose of this study is to show if addition of Rituximab to intensive induction (MegaCHOP/ESHAP) and high-dose consolidation (BEAM) improves progression-free and overall survival in patients younger than 65 years with aggressive B-cell lymphoma and aaIPI 2 or 3.

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Key information

Conditions

Diffuse Large B-Cell Lymphoma. Follicular Lymphoma Grade III Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Primary Mediastinal B-cell Lymphoma

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Brno-Bohunice, Brno, Czechia

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About this study

Previous study of Czech Lymphoma Study Group (4_2002)have shown that intensive induction (MegaCHOP - Cyclophosphamide 3 g/m2, Vincristine 2 mg, Adriamycin 75 mg/m2, Prednisone 300 mg/m2 every three weeks with G-CSF for three cycles, followed by ESHAP - Etoposide 240 mg/m2, Cisplatin 100 mg/m2, Solumedrol 2000 mg and cytarabine 2000 mg/m2 for three cycles every three weeks with G-CSF) followed by intensive consolidation (BEAM) and stem cell support improves progression-free survival in adult patients (18-65 years old) with aggressive B-cell lymphoma (namely, diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma and follicular lymphoma grade II) with aaIPI 2 and namely, with aaIPI 3. This study was aimed to find out if addition of four to six doses of Rituximab 375 mg/m2 on first day of every cycle of intensive induction further improves prognosis of these patients.

Inclusion criteria

for this trial were:

  • newly diagnosed aggressive B-cell lymphoma, namely diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma and follicular lymphoma grade III
  • age 18-65 years
  • age adjusted IPI (International Prognostic Index) score 2 or 3
  • ECOG performance status 0-3
  • signed informed consent

Exclusion criteria

were:

  • relapsed lymphoma
  • previous treatment (up to one cycle of standard pretreatment - COP, CHOP or steroids was permitted and later became mandatory to decrease disease burden and/or improve the performance status of the patient)
  • Burkitt lymphoma
  • posttransplant lymphoproliferation
  • CNS involvement
  • other malignant tumor in previous history, except basalioma, skin squamocellular carcinoma or cervical carcinoma in situ
  • other serious comorbidity

Primary endpoints was progression-free survival

Secondary endpoints were:

  • rate of complete remission and overall response rate
  • overall survival
  • toxicity of the protocol, measured as grade III-IV toxicity and/or inability to finish the protocol as planned

Planned number of accrued patients was 100.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aggressive B-cell lymphoma, namely diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, follicular lymphoma grade III
  • Age 18-65 years
  • Age-adjusted IPI score 2-3
  • ECOG performance status 0-3
  • Signed informed consent

Exclusion criteria

  • Burkitt lymphoma
  • Posttransplant lymphoproliferation
  • Previous treatment (up to one cycle of standard pretreatment with COP, CHOP or steroids permitted and latter mandatory to decrease tumor burden and/or improve performance status)
  • Other tumor in previous history with the exception of basalioma, squamous cell carcinoma of the skin or cervical carcinoma in situ
  • Pregnancy/lactation
  • CNS involvement
  • Other serious comorbidities

Treatment and study plan

immunotherapy

Procedure

Given together with induction chemotherapy:

Rituximab - 375 mg/m2 iv every 3 weeks, 4-6 doses

Induction treatment part 1

Procedure

cyclophosphamide 3000 mg/m2 iv every 3 weeks, 3 cycles vincristin 2 mg iv every 3 weeks, 3 cycles doxorubicin 75 mg/m2 iv every 3 weeks, 3 cycles Prednisolone 300 mg/m2 divided into five days po every 3 weeks, 3 cycles pegfilgrastim 6 mg sc every 3 weeks.

3 cycles consisting of combination treatment of above mentioned drugs are given.

Induction treatment part 2 with PBPC collection

Procedure

Starts three weeks after last cycle of Induction part 1.

Etoposide 240 mg/m2 divided into equal doses for four days, together with methylprednisolone 2000 mg divided into equal doses for four days, together with cisplatin 100 mg/m2 divided into equal doses for four days, and together with cytarabine 2000 mg/m2 iv one dose on 4th day of treatment. Filgrastim 10-12 ug/kg from day five after start of chemotherapy untill stem cell collection.

Peripheral blood progenitor cell collection (PBPC) is started when CD34 positive cells are >20/cubic milimeter of blood and continued untill 5 million of CD34 positive cells are collected from peripheral blood.

Induction treatment part 3

Procedure

Part 3 of induction treatment is given approximately one week after the end of Part 2.

Etoposide 240 mg/m2 divided into equal doses for four days, methylprednisolone 2000 mg divided into equal doses for four days, cisplatin 100 mg/m2 divided into equal doses for four days, cytarabine 2000 mg/m2 iv one dose on day 4 of chemotherapy and pegfilgrastim 6 mg on day five of chemotherapy are given twice three weeks apart.

Consolidation treatment part 1: HD-chemotherapy with ASCT

Procedure

Consolidation treatment Part 1 starts 4-8 weeks after the second cycle of Induction treatment Part 3.

High dose chemotherapy (HD-chemotherapy) consists of:

BCNU 300 mg/m2 is given on day 1, etoposide 800 mg/m2 divided into four equal doses is given on day 2-5, cytarabine 1600 mg/m2 divided into eight equal doses is given on day 2-5, melphalan 140 mg/m2 is given on day 6.

On day 7, collected stem cells from peripheral blood (see Induction treatment part 1) are infused back to the patient. This is called autologous transplantation (ASCT). Filgrastim 5 ug/kg is given from day 14 (start of the chemotherapy being day 1) until neutrophil recovery.

Consolidation treatment part 2: Radiotherapy

Radiation

Radiotherapy is started given 4-8 weeks after the autologous transplantation. It is given to patients with initially bulky disease (>10 cm at diagnosis) or to patients with residual disease after Induction treatment part 1-3 and Consolidation treatment part 1. 30-40 Gy are given in 2 Gy fractions over 3-4 weeks.

Primary outcomes

  1. Progression-free survival

    Time frame: 3 years

Secondary outcomes

  1. Complete remission and overall response rate

    Time frame: One year

  2. Overall survival

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Czech Lymphoma Study Group

Other

Collaborators

  • Hoffmann-La Roche
  • Ministry of Health, Czech Republic

Registry information

Official study title

Phase II Study of Intensive Induction (R-MegaCHOP/ESHAP)Followed By Intensive Consolidation (BEAM) In Treatment Of High-Risk Aggressive B-Cell Lymphomas

Acronym: R-MCEB

Important dates

Study start
2002
Study completion
2006
First posted
Nov 14, 2007
Registry last updated
Nov 14, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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