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):Z BEAM 2

Phase 1

• Conditions: Diffuse Large B cell Lymphoma; MedDRA version: 9.1Level: LLTClassification code 10012818Term: Diffuse large B-cell lymphoma

• Registration Number: EUCTR2007-000270-23-BE
• Lead Sponsor: GELA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-22
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

-Aged from 18 to 65 years,
-Patient with pathologically proven large B-Cell lymphoma CD20 positive (WHO classification):Diffuse large B cell lymphoma, Adverse prognostic factors: IPI >1.
-In CR, or partial response to first line treatment,
-Treated with first line chemotherapy regimen containing rituximab, R CHOP like or R ACVBP
-Chemo-sensitive disease
- PET scan before transplant
-Eligible for autologous stem cell transplantation,
-ECOG performance status 0 to 2,
-With a minimum life expectancy of 3 months,
-Negative HIV, HBV and HCV serologies < 4 weeks (except after vaccination),
-Signed informed consent form.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Histological transformation in diffuse large cell from a low grade B-Cell lymphoma, Any type of low grade lymphoma
-Prior transplantation, Prior exposure to Zevalin
- Contraindication to any drug contained in the chemotherapy regimens,
- Large bone marrow irradiation > 40%,
-Bone marrow infiltration
-Lack of sufficient autologous hematopoietic stem cells for transplantation,
-Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study,
-Any serious active disease or co-morbid medical condition (according to the investigator’s decision and information provided in the IDB),
-Poor bone marrow reserve as defined by neutrophils < 1.5 G/l or platelets < 100 G/l.
-Poor renal function (creatinin level > 2.5 maximum normal level) unless these abnormalities are related to the lymphoma,
-Poor hepatic function (total bilirubin level > 30 µmol/l,, transaminases > 2.5 maximum normal level) unless these abnormalities are related to the lymphoma,
-Central nervous system or meningeal involvement by lymphoma,
-Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma,
-Prior treatment with murine antibodies
-Known hypersensitivity to murine antibodies or proteins,
-Pregnant woman,
-Adult patient unable to give informed consent because of intellectual impairment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified