NCT00138086

Brief Summary

The objective of this study is to evaluate the efficacy and the safety of Zevalin-BEAM preparative regimen before autologous stem cell transplantation (ASCT) as measured by the event free survival (EFS). The goal is to obtain a 15% increase of EFS at 2 years.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2005

Typical duration for phase_2

Geographic Reach
3 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2005

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

September 8, 2006

Status Verified

September 1, 2006

First QC Date

August 29, 2005

Last Update Submit

September 6, 2006

Conditions

B-Cell Lymphoma

Keywords

lymphomachemotherapyZevalin ( Yttrium-90 Ibritumomab Tiuxetan)

Outcome Measures

Primary Outcomes (1)

  • EFS (event free survival)

Secondary Outcomes (4)

  • Overall response rate (ORR)

  • Toxicities, transplant related mortality at 1 and 2 years

  • Hematological reconstitution after ASCT and 1 year

  • Time to progression or relapse, disease free survival for complete responders after ASCT, overall survival

Interventions

Zevalin plus BEAMDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 to 65 years
  • Patients with pathologically proven at relapse, low grade B-cell lymphoma CD20- positive (World Health Organization \[WHO\] classification):
  • Marginal zone;
  • Lymphocytic; or
  • Follicular.
  • In relapse after complete remission (CR), less than partial remission (PR) or partial response (maximum of 3 lines of treatment)
  • Previously treated with chemotherapy regimen with or without rituximab
  • With a chemo-sensitive disease using salvage therapy
  • Eligible for autologous stem cell transplantation
  • ECOG performance status 0 to 2
  • Minimum life expectancy of 3 months
  • Negative HIV, hepatitis B virus (HBV) and hepatitis C virus (HCV) serologies \< 4 weeks (except after vaccination)
  • Signed informed consent form

You may not qualify if:

  • Histological transformation in diffuse large cell from a low grade B-cell lymphoma
  • Prior transplantation
  • Contraindication to any drug contained in the chemotherapy regimens
  • Large bone marrow irradiation \> 40%
  • Bone marrow infiltration \> 25%
  • Lack of sufficient autologous stem cells for transplantation
  • Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study
  • Any serious active disease or co-morbid medical condition (according to the investigator's decision and information provided in the Investigational Drug Brochure \[IDB\])
  • Poor bone marrow reserve as defined by neutrophils \< 1.5 G/l or platelets \< 100 G/l, unless related to bone marrow infiltration
  • Poor renal function (creatinine level \> 2.5 maximum normal level) unless abnormalities are related to the lymphoma
  • Poor hepatic function (total bilirubin level \> 30 mmol/l, transaminases \> 2.5 maximum normal level) unless abnormalities are related to the lymphoma
  • Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma
  • Presence of anti-murine antibody (HAMA) reactivity
  • Known hypersensitivity to murine antibodies or proteins
  • Pregnant women
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Groupe d'Etude des Lymphomes de l'adulte

Mont-Godinne, Belgium

Location

Hôpital Henri Mondor

Créteil, 94010, France

Location

Hématologie CHU de Lille

Lille, 59000, France

Location

Institut Curie

Paris, 75005, France

Location

Hôpital Saint Louis

Paris, 75010, France

Location

Service d'Hématologie - Centre Hospitalier Lyon-Sud

Pierre-Bénite, 69495, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Institut Gustave Roussy

Villejuif, France

Location

Schweirische Arbeitsgruppe fur klinische Krebsforschung

Lausanne, Switzerland

Location

Related Publications (5)

  • Brice P, Simon D, Bouabdallah R, Belanger C, Haioun C, Thieblemont C, Tilly H, Harousseau JL, Doyen C, Martin C, Brousse N, Solal-Celigny PH; Groupe d'Etude des Lymphomes de l'Adulte (GELA). High-dose therapy with autologous stem-cell transplantation (ASCT) after first progression prolonged survival of follicular lymphoma patients included in the prospective GELF 86 protocol. Ann Oncol. 2000 Dec;11(12):1585-90. doi: 10.1023/a:1008399623564.

    PMID: 11205467BACKGROUND

  • Mills W, Chopra R, McMillan A, Pearce R, Linch DC, Goldstone AH. BEAM chemotherapy and autologous bone marrow transplantation for patients with relapsed or refractory non-Hodgkin's lymphoma. J Clin Oncol. 1995 Mar;13(3):588-95. doi: 10.1200/JCO.1995.13.3.588.

    PMID: 7884420BACKGROUND

  • Witzig TE, White CA, Gordon LI, Wiseman GA, Emmanouilides C, Murray JL, Lister J, Multani PS. Safety of yttrium-90 ibritumomab tiuxetan radioimmunotherapy for relapsed low-grade, follicular, or transformed non-hodgkin's lymphoma. J Clin Oncol. 2003 Apr 1;21(7):1263-70. doi: 10.1200/JCO.2003.08.043.

    PMID: 12663713BACKGROUND

  • Fung HC, Forman SJ, Nademanee A, Molina A, Yamauchi D, Speilberger R, Kogut N, Sahebi F, Parker P, Rodriguez R, Krishnan A, Popplewell L, Wong J, and Raubitschek A. A new preparative regimen for older patients with aggressive CD20-positive B-cell lymphoma utilizing standard-dose Yttrium-90 Ibritumomab Tiuxetan (Zevalin) radioimmunotherapy (RIT) combined with high-dose BEAM followed by autologous hematopoietic cell transplantation (AHCT) : targeted intensification without increased transplant-related toxicity. Blood 2003, forty-fifth annual meeting of the American Society of Hematology, abstract 870.

    BACKGROUND

  • Nademanee A, Forman SJ, Molina A, Kogut N, Fung HC, Yamauchi D, Anderson A-L, Smith D, Liu AN, and Raubitschek A. High-dose radioimmunotherapy with yttrium 90 (90Y) ibritumomab tiuxetan with high-dose etoposide (VP-16) and cyclophosphamide (CY) followed by autologous hematopoietic cell transplantation (AHCT) for poor-risk or relapsed B-cell non-Hodgkin's lymphoma (NHL): update of a phase I/II trial. J Clin Oncol 2004, fortieth annual meeting of the American Society of Clinical Oncology, abstract 6504.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Lymphoma, B-CellLymphoma

Interventions

ibritumomab tiuxetan

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Christian Gisselbrecht, MD PHD

    Lymphoma Study Association

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 29, 2005

First Posted

August 30, 2005

Study Start

March 1, 2005

Study Completion

March 1, 2009

Last Updated

September 8, 2006

Record last verified: 2006-09

Locations

BE(1)FR(7)CH(1)