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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)


Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Lymphoma, Large Cell, Diffuse

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Trial Information

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)


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Christian Gisselbrecht, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Lymphoma Study Association

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

ZBEAM2

NCT ID:

NCT00689169

Start Date:

August 2007

Completion Date:

Related Keywords:

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

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