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

NCT00521560 | Completed Phase 2 DMC

• 1 other identifier: DSHNHL 2004-R4
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Keywords

High-Dose Radio-Immuno- and Chemotherapy; stem cell transplantation; 90Y-Ibritumomab-Tiuxetan

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

1

EXPERIMENTAL

Drug: Zevalin

Interventions

Zevalin 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

Also known as: 90Y-Ibritumomab-Tiuxetan

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 qualify 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

Sponsors & Collaborators

• Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH: lead

Study Sites (1)

Institut für anwendungsorientierte Forschung und klinische Studien (IFS GmbH)

Göttingen, 37075, Germany

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

ibritumomab tiuxetan

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Bertram Glass, Prof. Dr.

  German Society of Cancer e.V.

  STUDY DIRECTOR

• Martin Gramatzki, MD PhD

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

  PRINCIPAL INVESTIGATOR

• Mattias Witzens Harig, MD PhD

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

  PRINCIPAL INVESTIGATOR

• Bernd Hertenstein, MD PhD

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

  PRINCIPAL INVESTIGATOR

• Georg Heß, MD PhD

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

  PRINCIPAL INVESTIGATOR

• Dorothea Kofahl-Krause, MD PhD

  MHH, Hämatologie, Hämostaseologie und Onkologie, Hannover, Germany

  PRINCIPAL INVESTIGATOR

• Norbert Schmitz, MD PhD

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

  PRINCIPAL INVESTIGATOR

• Jörg Schubert, MD PhD

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

  PRINCIPAL INVESTIGATOR

• Lutz Uharek Uharek, MD PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2007
• First Posted: August 28, 2007
• Study Start: March 1, 2006
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2012
• Last Updated: February 15, 2013

Record last verified: 2013-02

Locations

DE (1)