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

NCT ID: NCT00521560

Last Updated: 2013-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2012-08-31

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

Conditions

Primary Non-Hodgkin-Lymphoma; Refractory Non-Hodgkin-Lymphoma; CD20+ Aggressive Non-Hodgkin's Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Zevalin

Intervention Type: DRUG

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

Interventions

Zevalin

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

Intervention Type: DRUG

Other Intervention Names

90Y-Ibritumomab-Tiuxetan

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:

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bertram Glass, Prof. Dr.

Role: STUDY_DIRECTOR

German Society of Cancer e.V.

Martin Gramatzki, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Städtisches Krankenhaus Kiel, II. Med. Uniklinik, Kiel, Germany

Mattias Witzens Harig, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Abteilung Innere Medizin V, Hämatologie, Onkologie, Heidelberg, Germany

Bernd Hertenstein, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Klinikum Bremen-Mitte gGmbH, Medizinische Klinik I, Bremen, Germany

Georg Heß, MD PhD

Role: PRINCIPAL_INVESTIGATOR

III Med., Schwerpunkt Hämatologie / Onkologie, Mainz, Germany

Dorothea Kofahl-Krause, MD PhD

Role: PRINCIPAL_INVESTIGATOR

MHH, Hämatologie, Hämostaseologie und Onkologie, Hannover, Germany

Norbert Schmitz, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Asklepios Klinik St. Georg, Hämatologische Abt., Hamburg, Germany

Jörg Schubert, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Universitätskliniken d. Saarlandes, Med. I, Homburg/Saar, Germany

Lutz Uharek Uharek, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Charité - Campus Benjamin Franklin, Med. III, Berlin, Germany

Locations

Institut für anwendungsorientierte Forschung und klinische Studien (IFS GmbH)

Göttingen, , Germany

Countries

Germany

Other Identifiers

DSHNHL 2004-R4

Identifier Type: -

Identifier Source: secondary_id

DSHNHL 2004-R4

Identifier Type: -

Identifier Source: org_study_id