Phase I/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

Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH1 site in 1 country28 target enrollmentMarch 2006

ConditionsPrimary Non-Hodgkin-Lymphoma Refractory Non-Hodgkin-Lymphoma CD20+ Aggressive Non-Hodgkin's Lymphoma

InterventionsZevalin

DrugsZevalin

Overview

Phase: Phase 2
Intervention: Zevalin
Conditions: Primary Non-Hodgkin-Lymphoma
Sponsor: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Enrollment: 28
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

March 2006

End Date

August 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

Responsible Party

Sponsor

Eligibility Criteria

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:
•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

Arms & Interventions

1

Intervention: Zevalin

Outcomes

Primary Outcomes

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.

Time Frame: 3 Year

Secondary Outcomes

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)