Completed

A Multi-Center Phase II Study to Investigate the Safety and Activity of SDX-105 (Bendamustine) in Combination With Rituximab in Patients With Relapsed Indolent or Mantle Cell Non-Hodgkin's Lymphoma (NHL)

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What is being tested

bendamustine and rituximab

Drug
Who is being recruted

Immune System Diseases+5

+ Immunoproliferative Disorders

+ Lymphatic Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: April 2004
See protocol details

Summary

Principal SponsorCephalon
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2004

Actual date on which the first participant was enrolled.

SUMMARY: This is an open label study combining Rituxan and SDX-105. Rituxan will be given on day 1 followed by a 30-60 minute intravenous infusion of SDX-105 on day 2 and day 3. Treatment will repeat every 21 days (a cycle). Treatment can continue for up to 6 cycles (about 4 months) if tumor status improves and there are no unacceptable side effects. Patients will be followed for up to 2 years or until disease progression. RATIONALE: Rituxan has been shown to increase the sensitivity of cells to chemotherapy. The combination of SDX-105 and Rituxan has been effective in both the laboratory and in a recent clinical study with Non-Hodgkin's lymphoma patients. PURPOSE: This study will evaluate the safety and effectiveness of SDX-105 plus Rituxan in patients with Non-Hodgkin's lymphoma who have relapsed after taking Rituxan.

Official TitleA Multi-Center Phase II Study to Investigate the Safety and Activity of SDX-105 (Bendamustine) in Combination With Rituximab in Patients With Relapsed Indolent or Mantle Cell Non-Hodgkin's Lymphoma (NHL) 
NCT00076349
Principal SponsorCephalon
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

66 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Immune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphomaLymphoma, Non-HodgkinLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic Type

Criteria

INCLUSION CRITERIA: Documented B-Cell NHL or mantle cell lymphoma * CD-20+ tumor * Indolent NHL: follicular B-cell lymphoma, diffuse small lymphoma, marginal zone lymphoma * Maximum of three prior chemotherapy regimens * Age of at least 18 years at Screening Visit (Site specific requirement may differ) EXCLUSION CRITERIA: * Refractory to rituximab, defined as progression of disease while being treated with rituximab or progression within 6 months of the last dose of rituximab (when given either as a single agent or in combination) * Previous chemotherapy or immunotherapy within 3 weeks prior to entering the study (6 weeks for nitrosoureas or mitomycin) or failure to recover from adverse events due to any agents administered previously * Use of investigational agents within 28 days of study * History of prior high dose chemotherapy with allogeneic stem cell support * History of prior radioimmunotherapy

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
open-label, single arm, clinical trial of bendamustine (SDX-105) plus rituximab

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 34 locations

Suspended

Alaska Cancer Research and Education Center

Anchorage, United StatesSee the location
Suspended

Bay Area Cancer Research Group

Concord, United States
Suspended

Wilshire Oncology Medical Group

La Verne, United States
Suspended

USC/Kenneth Norris Jr. Cancer Hospital and Research Institute

Los Angeles, United States
Completed34 Study Centers