Targeted Intensification With ZBEAM and Autologous Stem Cell Transplantation in Patients With High-grade B-Cell Lymphoma
ZBEAM2
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)
2 other identifiers
interventional
75
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2007
Longer than P75 for phase_2
1 active site
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
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 29, 2008
CompletedFirst Posted
Study publicly available on registry
June 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedMarch 7, 2018
March 1, 2018
3.4 years
May 29, 2008
March 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
2 years
Secondary Outcomes (1)
Overall response rate (ORR) (Complete Response CR and Partial Response PR)
100 days
Study Arms (1)
Experimental
EXPERIMENTALZBEAM (Zevalin, BCNU, Etoposide, Aracytine, Melphalan) ASCT Rituximab
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lymphoma Study Associationlead
- Bayercollaborator
Study Sites (1)
service d'onco hématologie adultes, hôpital Saint Louis
Paris, 75010, France
Related Publications (1)
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.
PMID: 25072780RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christian Gisselbrecht, MD
Lymphoma Study Association
- PRINCIPAL INVESTIGATOR
Christophe Fruchart, MD
Lymphoma Study Association
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2008
First Posted
June 3, 2008
Study Start
August 1, 2007
Primary Completion
January 1, 2011
Study Completion
January 1, 2014
Last Updated
March 7, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share