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

Primary Purpose

Lymphoma, Large Cell, Diffuse

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
ZBEAM (Zevalin, BCNU, Etoposide, Aracytine, Melphalan)
ASCT
Rituximab
Sponsored by
Lymphoma Study Association
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Large Cell, Diffuse focused on measuring Lymphoma, Lymphoma Diffuse, B-Cell lymphoma, Aggressive lymphoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • service d'onco hématologie adultes, hôpital Saint Louis

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

ZBEAM (Zevalin, BCNU, Etoposide, Aracytine, Melphalan) ASCT Rituximab

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall response rate (ORR) (Complete Response CR and Partial Response PR)
100 days after ASCT

Full Information

First Posted
May 29, 2008
Last Updated
March 6, 2018
Sponsor
Lymphoma Study Association
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00689169
Brief Title
Targeted Intensification With ZBEAM and Autologous Stem Cell Transplantation in Patients With High-grade B-Cell Lymphoma
Acronym
ZBEAM2
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lymphoma Study Association
Collaborators
Bayer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Large Cell, Diffuse
Keywords
Lymphoma, Lymphoma Diffuse, B-Cell lymphoma, Aggressive lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
ZBEAM (Zevalin, BCNU, Etoposide, Aracytine, Melphalan) ASCT Rituximab
Intervention Type
Drug
Intervention Name(s)
ZBEAM (Zevalin, BCNU, Etoposide, Aracytine, Melphalan)
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
ASCT
Intervention Description
ASCT : D0
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
Rituximab 250 mg/m² :D-21 D-14
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Overall response rate (ORR) (Complete Response CR and Partial Response PR)
Description
100 days after ASCT
Time Frame
100 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Gisselbrecht, MD
Organizational Affiliation
Lymphoma Study Association
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christophe Fruchart, MD
Organizational Affiliation
Lymphoma Study Association
Official's Role
Principal Investigator
Facility Information:
Facility Name
service d'onco hématologie adultes, hôpital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25072780
Citation
Fruchart C, Tilly H, Morschhauser F, Ghesquieres H, Bouteloup M, Ferme C, Van Den Neste E, Bordessoule D, Bouabdallah R, Delmer A, Casasnovas RO, Ysebaert L, Ciappuccini R, Briere J, Gisselbrecht C. Upfront consolidation combining yttrium-90 ibritumomab tiuxetan and high-dose therapy with stem cell transplantation in poor-risk patients with diffuse large B cell lymphoma. Biol Blood Marrow Transplant. 2014 Dec;20(12):1905-11. doi: 10.1016/j.bbmt.2014.07.024. Epub 2014 Jul 26.
Results Reference
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Targeted Intensification With ZBEAM and Autologous Stem Cell Transplantation in Patients With High-grade B-Cell Lymphoma

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