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

• Sponsor: University of Cologne (Other)
• Overall Status: Completed
• CT.gov ID: NCT00147953
• Collaborator: (none)
• Enrollment: 30
• Location: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Non-Hodgkin's Lymphoma	Drug: Rituximab; Procedure: Total nodal irradiation	Phase 2

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of Rituximab Plus Low-Dose Radiotherapy in Patients With Relapsed Non-Hodgkin's Lymphoma
• Study Start Date: Jun 1, 2004

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Toxicity []

2. Time to progression []

3. Response duration []

4. Quality-of-Life []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Cologne	Cologne	NRW	Germany	50924

Sponsors and Collaborators

• University of Cologne

Investigators

• Principal Investigator: Andreas Engert, University of Cologne
• Principal Investigator: R.-P. Mueller, University of Cologne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00147953
• Other Study ID Numbers: Ritux plus TNI
• First Posted: Sep 7, 2005
• Last Update Posted: Jan 27, 2010
• Last Verified: Jan 1, 2010

• Keywords provided by , ,: NHL; Lymphoma; Radiotherapy; Rituximab; Palliative treatment
• Additional relevant MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Rituximab

Study Results

No Results Posted as of Jan 27, 2010