Targeted Intensification Utilizing ZBEAM Followed by Autologous Stem Cell Transplantation (ASCT) in Patients With High-grade B-Cell Lymphoma (ZBEAM2)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Lymphoma Study Association.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Bayer
Information provided by:
Lymphoma Study Association
ClinicalTrials.gov Identifier:
NCT00689169
First received: May 29, 2008
Last updated: August 26, 2009
Last verified: August 2009
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Lymphoma Study Association:

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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate (ORR) (Complete Response CR and Partial Response PR) [ Time Frame: D100 post ASCT ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: August 2007
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Pr Christian Gisselbrecht, Groupe d'étude des lymphomes de l'adulte
ClinicalTrials.gov Identifier: NCT00689169     History of Changes
Other Study ID Numbers: ZBEAM2, EUDRACT: 2007-000270-23
Study First Received: May 29, 2008
Last Updated: August 26, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Cytarabine
Melphalan
Rituximab
Etoposide
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Alkylating Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 20, 2014