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CompletedNCT00147953Updated Jan 27, 2010

Study to Evaluate the Efficacy of Rituximab in Combination With Low-dose Radiotherapy in Patients With Relapsed Non-Hodgkin's Lymphoma

A Phase 2 interventional study of Rituximab and Total nodal irradiation in Non-Hodgkin's Lymphoma, sponsored by University of Cologne. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-01-27.

Sponsored by University of Cologne · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study aims to assess the short term efficacy of a combination of rituximab and low-dose radiotherapy in patients with non-Hodgkin's lymphoma.

Read the detailed description

Rituximab and low-dose total-nodal irradiation both have shown promising activity in patients with NHL. Moreover, the radiolabelled antibody Zevalin has been approved for the treatment of relapsed NHL. The patients in this study have a poor prognosis. The treatment strategy aims to control the disease and to ameliorate disease related symptoms with minimal toxicity. Both, rituximab and low-dose radiotherapy are associated with minor toxicity if applied alone.

The primary objective of the study is therefore to assess the short term efficacy of a combination of rituximab and low-dose radiotherapy in patients with non-Hodgkin's lymphoma.

02

Conditions studied

  • Non-Hodgkin's Lymphoma

Keywords

  • NHL
  • Lymphoma
  • Radiotherapy
  • Rituximab
  • Palliative treatment
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 30 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

University of Cologne is the lead sponsor of 199 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • B-cell non-Hodgkin's lymphoma
  • At least one prior antitumor therapy
  • ECOG performance status 0-2
  • No major organ dysfunction
  • Written informed consent

Exclusion criteria

Exclusion Criteria:

  • The following histologies are excluded: Burkitt's lymphoma, mantle-cell lymphoma, primary CNS-lymphoma, HIV-associated lymphoma
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Interventions

  • DrugRituximab
  • ProcedureTotal nodal irradiation
06

What researchers measure

Primary outcomes

  1. Overall response rate (complete and partial response rate)

Secondary outcomes

  1. Toxicity

  2. Time to progression

  3. Response duration

  4. Quality-of-Life

07

Study locations

1 site
  • University of Cologne
    Cologne, NRW 50924, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00147953
Lead sponsor
University of Cologne
First posted
Sep 7, 2005
Start date
Jun 2004
Last update
Jan 27, 2010

Study contacts

Andreas Engert
principal investigator · University of Cologne
R.-P. Mueller
principal investigator · University of Cologne
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.

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