NCT01926639

Brief Summary

Patients with non-curable disseminated follicular lymphoma receive local radiotherapy targeting single lymph nodes and injection of low-dose rituximab (anti-CD20) and autologous dendritic cells. The therapy is repeated 3 times, targeting different lesion. Aims are to induce tumor immunity and clinical responses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2009

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

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

October 1, 2009

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 23, 2014

Status Verified

October 1, 2014

Enrollment Period

5 years

First QC Date

August 19, 2013

Last Update Submit

October 22, 2014

Conditions

Follicular Lymphoma

Keywords

Follicular lymphomaRituximabAutologous dendritic cellsCancer vaccine

Outcome Measures

Primary Outcomes (1)

  • Response rate

    Clinical response measured by CT and PET/CT and immune response

    5 years

Secondary Outcomes (1)

  • Immune response

    1 year

Study Arms (1)

Radiotherapy , rituximab and DC

EXPERIMENTAL

Treatment repeated 3 times and targeting different lymph nodes

Biological: Radiotherapy, rituximab and DC

Interventions

Radiotherapy, rituximab and DCBIOLOGICAL

Lymphoma lymph nodes are irradiated with 8 Gy single treatment and injected with rituximab (5 mg) and autologous DC intratumorally. The treatment is performed 3 times targeting different lymph nodes

Radiotherapy , rituximab and DC

Eligibility Criteria

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

You may qualify if:

  • Age 18 years and older
  • Histologically confirmed (by WHO classification) untreated and relapsed indolent non-Hodgkin's B-cell lymphoma of low-grade follicular, marginal zone, lymphoplasmocytic or small lymphocytic subtypes.
  • Stage III/IV
  • Adequate bone marrow function (leukocyte count\>2,0, neutrophil count\>1.0, platelets\>50)
  • Two or more separate lymph nodes \> 1,5 cm available for biopsy or treatment.
  • Measurable disease present other than biopsy site and injection site(s).
  • Required wash-out period after previous treatment: Chemotherapy - 8 weeks, Radiotherapy - 4 weeks, Rituximab - 12 weeks
  • WHO status 0-1
  • Life expectancy of more than 6 months
  • Written informed consent
  • Able to comply with the treatment protocol -

You may not qualify if:

  • Patients with progressive lymphoma in need of systemic therapy or standard dose irradiation.
  • Chronic bacterial, viral or fungal infection
  • Pre-existing autoimmune or antibody mediated disease including: systemic lupus, erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia, but excluding controlled thyroid disease, or the presence of autoantibodies without clinical autoimmune disease.
  • Known history of HIV
  • Central nervous system involvement of lymphoma
  • Current anticoagulant therapy which can not safely be paused during treatment injections (ASA \< 325 mg/day allowed)
  • Pregnancy -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, Oslo County, 0310, Norway

Location

Related Publications (1)

  • Kolstad A, Kumari S, Walczak M, Madsbu U, Hagtvedt T, Bogsrud TV, Kvalheim G, Holte H, Aurlien E, Delabie J, Tierens A, Olweus J. Sequential intranodal immunotherapy induces antitumor immunity and correlated regression of disseminated follicular lymphoma. Blood. 2015 Jan 1;125(1):82-9. doi: 10.1182/blood-2014-07-592162. Epub 2014 Oct 7.

    PMID: 25293773DERIVED

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

RadiotherapyRituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Arne Kolstad, MD, PhD

    Oslo University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2013

First Posted

August 21, 2013

Study Start

October 1, 2009

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

October 23, 2014

Record last verified: 2014-10

Locations

NO(1)