CD20+ Aggressive Non-Hodgkin's Lymphoma, Primary Non-Hodgkin-Lymphoma, Refractory Non-Hodgkin-Lymphoma
Conditions
Keywords
High-Dose Radio-Immuno- and Chemotherapy, stem cell transplantation, 90Y-Ibritumomab-Tiuxetan
Brief summary
Phase II Study Concomitant High-Dose Radio-Immuno- and Chemotherapy with simultaneous application of Zevalin and BEAM followed by autologous peripheral stem cell transplantation in relapsed and refractory CD 20+ Non-Hodgkin's lymphoma
Interventions
DRUGZevalin
All applications of 90Y-Ibritumomab-Tiuxetan will be preceded by rituximab infusions at a dose of 250 mg/m2 at days -21 and day -14 (DL1) or day -12 (DL2) or day -10 (DL3-5), respectively. High dose therapy will be given as BEAM
Sponsors
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome variable is the highest achievable dose level of 90Y-Zevalin administered immediately before BEAM high-dose therapy and followed by autologous stem cell transplantation. | 3 Year |
Secondary
| Measure | Time frame |
|---|---|
| Treatment related mortality (TRM), freedom from progression (FFP), Survival (OS), progression free survival (PFS) grade III -IV toxicity (CTC) on lung, liver and kidney | 3 Years |
Countries
Germany
Outcome results
None listed