Targeted Intensification With ZBEAM and Autologous Stem Cell Transplantation in Patients With High-grade B-Cell Lymphoma (ZBEAM2)

March 6, 2018 updated by: Lymphoma Study Association

Targeted Intensification by a Preparative Regimen for Patients With High-grade B-Cell Lymphoma Utilizing Standard-dose Yttrium-90 Ibritumomab Tiuxetan (Zevalin) Radioimmunotherapy (RIT) Combined With High-dose BEAM Followed by Autologous Stem Cell Transplantation (ASCT)

The purpose of this study is to evaluate the efficacy and the safety of a preparative regimen utilizing standard-dose Yttrium-90 Ibritumomab Tiuxetan (Zevalin) radioimmunotherapy combined with high-dose BEAM followed by ASCT after first line treatment in patients aged from 18 to 65 years with poor prognosis CD 20 Diffuse Large B-Cell lymphoma

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75010
        • service d'onco hématologie adultes, hôpital Saint Louis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged from 18 to 65 years.
  • Patient with pathologically proven, high grade B-cell Lymphoma CD 20 positive (WHO classification) :
  • Diffuse large B cell lymphoma.
  • Adverse prognostic factors IPI>1
  • In Complete Remission, or partial response to first line treatment.
  • Previously treated with chemotherapy regimen containing rituximab: R CHOP or R ACVBP
  • Chemo-sensitive disease
  • PET Scan prior transplant
  • Eligible for autologous stem cell transplantation
  • With a minimum life expectancy of 3 months.
  • Negative HIV, HBV and HCV serologies (in the last 4 weeks except after vaccination).
  • Having previously signed a written informed consent.

Exclusion Criteria:

  • Histological transformation in diffuse large B cell lymphoma, any type of low grade lymphoma
  • More than one line of treatment. Prior transplantation. Prior exposure to Zevalin
  • Central nervous system or meningeal involvement by lymphoma.
  • Contraindication to any drug contained in the chemotherapy regimen.
  • Any serious active disease or co-morbid medical condition (according to the investigator's decision and information provided in the IDB).
  • Poor renal function (creatinin level up to 2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
  • Poor hepatic function (total bilirubin level up to 30 micro mol/l, transaminases up to 2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
  • Poor bone marrow reserve as defined by neutrophils less than 1.5 G/l or platelets less than 100 G/l
  • Large bone marrow irradiation more than 40percent.
  • Bone marrow infiltration
  • Lack of sufficient autologous hematopoietic stem cells for transplantation.
  • Prior treatment with murine antibodies
  • Known hypersensibility to murine antibodies or proteins
  • Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors 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.
  • Adult patient unable to give informed consent because of intellectual impairment.
  • Pregnant or lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
ZBEAM (Zevalin, BCNU, Etoposide, Aracytine, Melphalan) ASCT Rituximab
Drug: ZBEAM (Zevalin, BCNU, Etoposide, Aracytine, Melphalan)
Zevalin 0.4 mCi/kg: D-14 BCNU 300 mg/m² : D-6 Etoposide 100 mg/m²/12h : D-6 D-5 D-4 D-3 Aracytine 200 mg/m²/12h : D-6 D-5 D-4 D-3 Melphalan 140 mg/m²: D-2
Procedure: ASCT
ASCT : D0
Drug: Rituximab
Rituximab 250 mg/m² :D-21 D-14

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Event free survival (EFS): events being death from any cause, relapse for complete responders and unconfirmed complete responders, progression during and after treatment and changes of therapy
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR) (Complete Response CR and Partial Response PR)
Time Frame: 100 days
100 days after ASCT
100 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lymphoma Study Association

Collaborators

Bayer

Investigators

  • Principal Investigator: Christian Gisselbrecht, MD, Lymphoma Study Association
  • Principal Investigator: Christophe Fruchart, MD, Lymphoma Study Association

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

May 29, 2008

First Submitted That Met QC Criteria

June 2, 2008

First Posted (Estimate)

June 3, 2008

Study Record Updates

Last Update Posted (Actual)

March 7, 2018

Last Update Submitted That Met QC Criteria

March 6, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZBEAM2
  • 2007-000270-23 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lymphoma, Large Cell, Diffuse

Clinical Trials on ZBEAM (Zevalin, BCNU, Etoposide, Aracytine, Melphalan)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe