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.
Sponsor:
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00302757
First received: March 10, 2006
Last updated: May 28, 2014
Last verified: May 2014
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University Hospital Tuebingen:

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
Study Completion Date: July 2011
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00302757

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

Additional Information:
No publications provided by University Hospital Tuebingen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00302757     History of Changes
Other Study ID Numbers: 2005-002206-37
Study First Received: March 10, 2006
Last Updated: May 28, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by University Hospital Tuebingen:
NHL
low and high grade non-Hodgkin lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014