A Study of Zevalin and Simultaneous Application of BEAM High-dose Chemotherapy Followed by Autologous Stem Cell Transplantation in Refractory and Relapsed Aggressive Non-Hodgkin Lymphomas
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age: 18 - 65 years
Risk group: 1) Progression on primary therapy 2) Initial or subsequent relapse
Histology: Diagnosis of relapsed aggressive non-Hodgkin lymphoma, whenever possible confirmed by an excision biopsy of a lymph node or by a sufficiently large biopsy of an extranodal site if no lymph node lesion is present. The expression of the CD20 antigen must be demonstrated in the primary lesion or in the relapse. Specifically, the following entities can be treated in this study:
B-NHL:
Grade III B follicular lymphoma Diffuse B-cell lymphoma centroblastic immunoblastic plasmoblastic anaplastic-large-cell T-cell rich B-cell lymphoma Primary effusion lymphoma Intravascular B-cell lymphoma Primary mediastinal B-cell lymphoma Mantle cell lymphoma, blastoid Variants of Burkitt's lymphoma Aggressive marginal zone lymphoma (monocytoid)
General condition: General condition ECOG 0-3 (Karnofsky: 40 - 100 %); for definition see Annex 14.10
Presence of declaration of participation of the center and the patient's written consent form
You may not be if
Prior mediastinal or extensive abdominal irradiation
Prior high-dose therapy and autologous stem cell transplantation
Impairment of renal function (creatinine \> 2.5 mg/dL, creatinine clearance \< 20 mL/min)
Impairment of hepatic function (bilirubin \> 2.0 mg/dL, cholinesterase \[CHE\] \< 2000 U/L)
Impairment of pulmonary function (transfer lung factor for CO \[TLCO\] \< 50 %, forced expiratory volume in 1 sec \[FEV1\] \< 60 %, vital capacity \[VC\] \< 60 %)
Relevant deterioration of the above organ functions on salvage therapy
Failure of stem cell mobilization
Active viral hepatitis
HIV infection
Other active or not conclusively curatively treated malignoma
Severe concomitant psychiatric illness or suspected lack of patient compliance
Pregnancy or unreliable contraception
Highly dynamic progress of lymphoma (lactate dehydrogenase \[LDH\] \> 1.5 x upper limit of normal \[ULN\]) after salvage therapy immediately prior to radioimmunotherapy
Clareo Health | A Study of Zevalin and Simultaneous Application of BEAM High-dose Chemotherapy Followed by Autologous Stem Cell Transplantation in Refractory and Relapsed Aggressive Non-Hodgkin Lymphomas
