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

Non-Hodgkin Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00302757
• Other study ID #: 2005-002206-37
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 10, 2006
• Last updated: May 28, 2014
• Start date: March 2006
• Est. completion date: July 2011

Study information

• Verified date: May 2014
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin Lymphoma

Intervention

Drug:
• Radioimmunotherapy

Procedure:
• allogeneic hematopoietic cell transplantation

Locations

Country	Name	City	State
Germany	Medical Center Charite Benjamin Franklin	Berlin
Germany	University of Dresden Medical Center	Dresden
Germany	Center for Marrow Transplantation, University of Essen	Essen
Germany	Medical Center University of Goettingen	Goettingen
Germany	Medical Center University of Hannover	Hannover
Germany	Medical Center University of Leipzig	Leipzig
Germany	Medical Center University of Muenster	Muenster
Germany	South West German Cancer Center, University of Tuebingen Medical Center	Tuebingen
Germany	Medical Center University of Ulm	Ulm
Germany	Stiftung Deutsche Klinik für Diagnostik GmbH	Wiesbaden
Germany	University of Wuerzburg Medical Center	Wuerzburg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	treatment related toxicity
Primary	engraftment
Secondary	disease response
Secondary	relapse rate
Secondary	disease free survival
Secondary	overall survival
Secondary	graft versus host disease (GVHD)
Secondary	immunoreconstitution

External Links

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