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

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ClinicalTrials.gov Identifier: NCT00689169
Recruitment Status : Completed
First Posted : June 3, 2008
Last Update Posted : March 7, 2018
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Lymphoma Study Association

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

Condition or disease Intervention/treatment Phase
Lymphoma, Large Cell, Diffuse Drug: ZBEAM (Zevalin, BCNU, Etoposide, Aracytine, Melphalan) Procedure: ASCT Drug: Rituximab Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2007
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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 Measures :
  1. Overall response rate (ORR) (Complete Response CR and Partial Response PR) [ Time Frame: 100 days ]
    100 days after ASCT



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00689169


Locations
France
service d'onco hématologie adultes, hôpital Saint Louis
Paris, France, 75010
Sponsors and Collaborators
Lymphoma Study Association
Bayer
Investigators
Principal Investigator: Christian Gisselbrecht, MD Lymphoma Study Association
Principal Investigator: Christophe Fruchart, MD Lymphoma Study Association

Publications of Results:
Responsible Party: Lymphoma Study Association
ClinicalTrials.gov Identifier: NCT00689169     History of Changes
Other Study ID Numbers: ZBEAM2
2007-000270-23 ( EudraCT Number )
First Posted: June 3, 2008    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Lymphoma Study Association:
Lymphoma
Lymphoma Diffuse
B-Cell lymphoma
Aggressive lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Etoposide phosphate
Rituximab
Etoposide
Melphalan
Cytarabine
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Immunosuppressive Agents
Antimetabolites, Antineoplastic
Antimetabolites