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
Recruitment status was Active, not recruiting
Sponsor:
Lymphoma Study Association
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
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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:
MedlinePlus related topics:
Lymphoma
Drug Information available for:
Cytarabine
Melphalan
Melphalan hydrochloride
Etoposide
Etoposide phosphate
Rituximab
Ibritumomab tiuxetan
U.S. FDA Resources
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
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 May 23, 2013