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

GELA0 个研究点目标入组 75 人开始时间: 2007年5月22日最近更新: 2017年8月21日

适应症

试验速览

暂无简介。

•-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

•- 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.

发起方

GELA