NCT00302757

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2006

Longer than P75 for phase_1

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 14, 2006

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

May 29, 2014

Status Verified

May 1, 2014

First QC Date

March 10, 2006

Last Update Submit

May 28, 2014

Conditions

Non-Hodgkin Lymphoma

Keywords

NHLlow and high grade non-Hodgkin lymphoma

Outcome Measures

Primary Outcomes (2)

  • treatment related toxicity

  • engraftment

Secondary Outcomes (6)

  • disease response

  • relapse rate

  • disease free survival

  • overall survival

  • graft versus host disease (GVHD)

  • +1 more secondary outcomes

Interventions

RadioimmunotherapyDRUG
allogeneic hematopoietic cell transplantationPROCEDURE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +5 more criteria

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Medical Center Charite Benjamin Franklin

Berlin, 12200, Germany

Location

University of Dresden Medical Center

Dresden, D-01307, Germany

Location

Center for Marrow Transplantation, University of Essen

Essen, 45122, Germany

Location

Medical Center University of Goettingen

Göttingen, 37099, Germany

Location

Medical Center University of Hannover

Hanover, 30625, Germany

Location

Medical Center University of Leipzig

Leipzig, 04103, Germany

Location

Medical Center University of Muenster

Münster, 48149, Germany

Location

South West German Cancer Center, University of Tuebingen Medical Center

Tübingen, 72076, Germany

Location

Medical Center University of Ulm

Ulm, 89081, Germany

Location

Stiftung Deutsche Klinik für Diagnostik GmbH

Wiesbaden, 65191, Germany

Location

University of Wuerzburg Medical Center

Würzburg, D-97070, Germany

Location

Related Publications (2)

  • Bethge WA, von Harsdorf S, Bornhauser M, Federmann B, Stelljes M, Trenschel R, Baurmann H, Dittmann H, Faul C, Vogel W, Kanz L, Bunjes D. Dose-escalated radioimmunotherapy as part of reduced intensity conditioning for allogeneic transplantation in patients with advanced high-grade non-Hodgkin lymphoma. Bone Marrow Transplant. 2012 Nov;47(11):1397-402. doi: 10.1038/bmt.2012.62. Epub 2012 Apr 16.

    PMID: 22504934DERIVED

  • Bethge WA, Lange T, Meisner C, von Harsdorf S, Bornhaeuser M, Federmann B, Stadler M, Uharek L, Stelljes M, Knop S, Wulf G, Trenschel R, Vucinic V, Dittmann H, Faul C, Vogel W, Kanz L, Bunjes D. Radioimmunotherapy with yttrium-90-ibritumomab tiuxetan as part of a reduced- intensity conditioning regimen for allogeneic hematopoietic cell transplantation in patients with advanced non-Hodgkin lymphoma: results of a phase 2 study. Blood. 2010 Sep 9;116(10):1795-802. doi: 10.1182/blood-2010-02-270538. Epub 2010 Jun 7.

    PMID: 20530284DERIVED

Related Links

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Radioimmunotherapy

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

ImmunotherapyImmunomodulationBiological TherapyTherapeuticsCombined Modality TherapyRadiotherapy

Study Officials

  • Wolfgang A Bethge, MD

    Medical Center University of Tuebingen

    PRINCIPAL INVESTIGATOR

  • Donald Bunjes, MD

    Medical Center University of Ulm

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 10, 2006

First Posted

March 14, 2006

Study Start

March 1, 2006

Study Completion

July 1, 2011

Last Updated

May 29, 2014

Record last verified: 2014-05

Locations

DE(11)