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AzTrials

Non-Hodgkin LymphomaPhase 1/2NCT00302757

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

A Phase 1/2 study testing Radioimmunotherapy and allogeneic hematopoietic cell transplantation in people with Non-Hodgkin Lymphoma, run by University Hospital Tuebingen at 11 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Non-Hodgkin Lymphoma
What is being tested?
Radioimmunotherapy and allogeneic hematopoietic cell transplantation
Type of treatment
Surgery or procedure
How many people
60 participants
Where
11 sitesGermany
Study dates
Mar 2006to Jul 2011
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 21Show fewer
  • 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

Who cannot join

  • 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
Show all 21Show fewer
  • 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

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Germany11 sites

  • Medical Center Charite Benjamin Franklin

    Berlin, 12200

  • University of Dresden Medical Center

    Dresden, D-01307

  • Center for Marrow Transplantation, University of Essen

    Essen, 45122

  • Medical Center University of Goettingen

    Göttingen, 37099

  • Medical Center University of Hannover

    Hanover, 30625

  • Medical Center University of Leipzig

    Leipzig, 04103

  • Medical Center University of Muenster

    Münster, 48149

  • South West German Cancer Center, University of Tuebingen Medical Center

    Tübingen, 72076

  • Medical Center University of Ulm

    Ulm, 89081

  • Stiftung Deutsche Klinik für Diagnostik GmbH

    Wiesbaden, 65191

  • University of Wuerzburg Medical Center

    Würzburg, D-97070

Other trials in Germany

About this 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

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.

Being tested
Radioimmunotherapy, allogeneic hematopoietic cell transplantation
Keywords
NHL, low and high grade non-Hodgkin lymphoma
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RadioimmunotherapyDrug

  • allogeneic hematopoietic cell transplantationProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. treatment related toxicity

  2. engraftment

Secondary outcomes (6)

  1. disease response

  2. relapse rate

  3. disease free survival

  4. overall survival

  5. graft versus host disease (GVHD)

  6. immunoreconstitution

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2006 (estimated)
  2. Study startMar 2006
  3. Study completionJul 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00302757
Sponsor's protocol ID
2005-002206-37
Other IDs
2005
Status last verified
May 2014
First submitted
10 Mar 2006
Last updated
29 May 2014
Results posted
No

Publications

  • 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.

    PubMed 22504934

  • 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.

    PubMed 20530284

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Radioimmunotherapy and allogeneic hematopoietic cell transplantation in people with Non-Hodgkin Lymphoma, run by University Hospital Tuebingen at 11 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

treatment related toxicity. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00302757, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2014.

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