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

NCT ID: NCT00689169

Last Updated: 2018-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2014-01-31

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

Conditions

Lymphoma, Large Cell, Diffuse

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

ZBEAM (Zevalin, BCNU, Etoposide, Aracytine, Melphalan) ASCT Rituximab

Group Type: EXPERIMENTAL

ZBEAM (Zevalin, BCNU, Etoposide, Aracytine, Melphalan)

Intervention Type: DRUG

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

ASCT

Intervention Type: PROCEDURE

ASCT : D0

Rituximab

Intervention Type: DRUG

Rituximab 250 mg/m² :D-21 D-14

Interventions

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

Intervention Type: DRUG

ASCT

ASCT : D0

Intervention Type: PROCEDURE

Rituximab

Rituximab 250 mg/m² :D-21 D-14

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

Lymphoma Study Association

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian Gisselbrecht, MD

Role: PRINCIPAL_INVESTIGATOR

Lymphoma Study Association

Christophe Fruchart, MD

Role: PRINCIPAL_INVESTIGATOR

Lymphoma Study Association

Locations

service d'onco hématologie adultes, hôpital Saint Louis

Paris, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 25072780 (View on PubMed)

Other Identifiers

2007-000270-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ZBEAM2

Identifier Type: -

Identifier Source: org_study_id