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

Lymphoma, Large Cell, Diffuse Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00689169
• Other study ID #: ZBEAM2
• Secondary ID: 2007-000270-23
• Status: Completed
• Phase: Phase 2
• First received: May 29, 2008
• Last updated: March 6, 2018
• Start date: August 2007
• Est. completion date: January 2014

Study information

• Verified date: March 2018
• Source: Lymphoma Study Association
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: January 2014
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Large Cell, Diffuse

Intervention

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

Locations

Country	Name	City	State
France	service d'onco hématologie adultes, hôpital Saint Louis	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Lymphoma Study Association	Bayer

Country where clinical trial is conducted

France, 

References & Publications (1)

Fruchart C, Tilly H, Morschhauser F, Ghesquières H, Bouteloup M, Fermé 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 t — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall response rate (ORR) (Complete Response CR and Partial Response PR)	100 days after ASCT	100 days