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Radioimmunotherapy With 90Y-Ibritumomab Tiuxetan as Part of a Dose Reduced Conditioning Regimen for Allogeneic Hematopoietic Cell Transplantation for the Treatment of Non-Hodgkin Lymphoma
This study has been completed.
Sponsored by: South West German Cancer Center
Information provided by: South West German Cancer Center
ClinicalTrials.gov Identifier: NCT00302757
  Purpose

The study evaluates the additional use of radioimmunotherapy with a 90-Yttrium labeled monoclonal antibody targeting lymphoma cells in two dose reduced conditioning regimens for allogeneic hematopoietic cell transplantation from human leukocyte antigen (HLA)-identical donors. Radioimmunotherapy should allow an increased anti-lymphoma effect of the conditioning while the allogeneic grafts may confer potent graft versus lymphoma effects and rescue from potential hematopoietic side effects of the radioimmunotherapy. The study evaluates the feasibility and toxicity of such approach and will also analyze disease response and survival of the patients treated.


Condition Intervention Phase
Non-Hodgkin Lymphoma
Drug: Radioimmunotherapy
Procedure: allogeneic hematopoietic cell transplantation
Phase I
Phase II

MedlinePlus related topics: Lymphoma
Drug Information available for: Ibritumomab tiuxetan
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title: Multicenter Phase I/II Study of Radioimmunotherapy With 90Y-Ibritumomab Tiuxetan in a Nonmyeloablative Conditioning Regimen for Allogeneic Hematopoietic Cell Transplantation From HLA-Identical Donors in Patients With Advanced Non-Hodgkin Lymphoma

Further study details as provided by South West German Cancer Center:

Primary Outcome Measures:
  • treatment related toxicity
  • engraftment

Secondary Outcome Measures:
  • disease response
  • relapse rate
  • disease free survival
  • overall survival
  • graft versus host disease (GVHD)
  • immunoreconstitution

Estimated Enrollment: 60
Study Start Date: March 2006
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with advanced CD20+ NHL (non-Hodgkin lymphoma) relapsed after at least two preceding chemotherapy regimens including treatment with rituximab or with relapse after autologous HCT (hematopoietic cell transplantation)

The following entities of lymphomas can be included in Arm A of the protocol:

Arm A:

  • Small lymphocytic lymphoma (SLL/CLL)
  • Mantle cell lymphoma (MCL)
  • Follicular lymphoma Grade 1-2
  • Marginal zone lymphoma (MZL)

    • Extranodal (MALT lymphoma)
    • Nodal (Monocytoid B-cell lymphoma)
    • Splenic

The following lymphoma entities can be included in Arm B of the protocol:

Arm B:

  • Diffuse large B-cell lymphoma/follicular lymphoma grade 3
  • Grade 3 follicular lymphoma
  • Blastic mantle cell lymphoma
  • Mediastinal B-cell lymphoma

    • Age > 18, < 70 years
    • Karnofsky score > 60%
    • HLA-identical related or unrelated donor
    • CD20+ lymphoma cells on biopsy or peripheral blood
    • Disease stage at inclusion: CR, PR or SD

Exclusion Criteria:

  • Patients with rapidly progressive disease
  • Less than 3 months after preceding HCT
  • CNS involvement with disease
  • Fungal infections with radiological progression after receipt of amphotericin B or active triazole for greater than 1 month
  • Liver function abnormalities with bilirubin > 2 mg/dL and elevation of transaminases higher than 2x upper limit of normal
  • Chronic active viral hepatitis
  • Ejection fraction < 40% on echocardiography
  • Patients with > grade II hypertension by CTC criteria
  • Creatinine clearance < 50 ml/min
  • Respiratory failure necessitating supplemental oxygen or DLCO < 30%
  • Allergy against murine antibodies
  • HIV infection
  • Female patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control during study treatment and for at least 12 months thereafter. (Women of childbearing potential must have a negative serum pregnancy test at study entry.)
  • Patients with pleural effusion or ascites
  • Concurrent severe and/or uncontrolled medical disease (e.g. uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months prior to the study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection) which could compromise participation in the study
  • Patients who received any investigational drugs less than 4 weeks before entry in this study or who have not as yet recovered from the toxic effects of such therapy
  • Patients who underwent surgery within 4 weeks of entering the study or patients who have not as yet recovered from the side-effects of such treatment
  • Patients with a history of psychiatric illness or condition which could interfere with their ability to understand the requirements of the study (this includes alcoholism/drug addiction)
  • Patients unwilling or unable to comply with the protocol
  • Unable to give informed consent
  • Enrollment in another trial interfering with the endpoints of this study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00302757

Locations
Germany
South West German Cancer Center, University of Tuebingen Medical Center
Tuebingen, Germany, 72076
University of Dresden Medical Center
Dresden, Germany, D-01307
University of Wuerzburg Medical Center
Wuerzburg, Germany, D-97070
Medical Center University of Leipzig
Leipzig, Germany, 04103
Medical Center University of Hannover
Hannover, Germany, 30625
Medical Center University of Ulm
Ulm, Germany, 89081
Medical Center University of Goettingen
Goettingen, Germany, 37099
Medical Center Charite Benjamin Franklin
Berlin, Germany, 12200
Center for Marrow Transplantation, University of Essen
Essen, Germany, 45122
Medical Center University of Muenster
Muenster, Germany, 48149
Stiftung Deutsche Klinik für Diagnostik GmbH
Wiesbaden, Germany, 65191
United Kingdom
The Royal Free and University College London Medical School London
London, United Kingdom, WC1E 6HX
Sponsors and Collaborators
South West German Cancer Center
Investigators
Principal Investigator: Wolfgang A Bethge, MD Medical Center University of Tuebingen
Principal Investigator: Donald Bunjes, MD Medical Center University of Ulm
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Study ID Numbers: 2005-002206-37
Study First Received: March 10, 2006
Last Updated: September 4, 2008
ClinicalTrials.gov Identifier: NCT00302757  
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by South West German Cancer Center:
NHL
low and high grade non-Hodgkin lymphoma

Study placed in the following topic categories:
Antibodies, Monoclonal
Lymphatic Diseases
Antibodies
Immunoproliferative Disorders
Lymphoma, small cleaved-cell, diffuse
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Immunoglobulins

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009