SDX-105 in Combination With Rituxan for Patients With Relapsed Indolent or Mantle Cell Non-Hodgkin's Lymphoma (NHL)

May 8, 2014 updated by: Cephalon

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Darlinghurst, Australia, NSW 2010
        • St. Vincent's Hospital
      • Westmead, Australia, NSW 2145
        • Westmead Hospital
    • Victoria
      • East Melbourne, Victoria, Australia, 8006
        • Peter Maccallum Cancer Institute
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital
  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Queen Elizabeth II Health Sciences Centre-Victoria General Site
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • The Royal Victoria Hospital Cancer Care Program Clinical Trials
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital Research Institute
      • Sudbury, ,, Ontario, Canada, P3E 5J1
        • North Eastern Ontario Regional Cancer Center
    • Quebec
      • Montreal, Quebec, Canada, H2L 4MI
        • Hopital Notre-Dame du CHUM
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Alaska Cancer Research and Education Center
    • California
      • Concord, California, United States, 94520
        • Bay Area Cancer Research Group
      • La Verne, California, United States, 91750
        • Wilshire Oncology Medical Group
      • Los Angeles, California, United States, 90033
        • USC/Kenneth Norris Jr. Cancer Hospital and Research Institute
      • Vista, California, United States, 92081
        • San Diego Cancer Center
    • Connecticut
      • Stamford, Connecticut, United States, 06902-3628
        • Hematology Oncology, P.C. Carl and Dorothy Bennett Cancer Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Medical Center - Lombardi Cancer Center
    • Florida
      • New Port Richey, Florida, United States, 34652
        • Pasco Hernando Oncology
    • Georgia
      • Columbus, Georgia, United States, 31902
        • John B. Amos Cancer Center
      • Lawrenceville, Georgia, United States, 30045
        • Suburban Hematology & Oncology Associates
      • Macon, Georgia, United States, 31201
        • Georgia Oncology Partners Research and Education Foundation
    • Indiana
      • South Bend, Indiana, United States, 46601
        • Northern Indiana Cancer Research Consortium
    • Louisiana
      • Metairie, Louisiana, United States, 70006-2921
        • Oncology and Hematology
      • Shreveport, Louisiana, United States, 71103
        • LSU Health Sciences Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel/Deaconess Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Comprehensive Cancer Center
    • Minnesota
      • Robbinsdale, Minnesota, United States, 55422
        • Hubert H. Humphrey Cancer Center
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • The Cancer Institute of New Jersey
    • New York
      • Great Neck, New York, United States, 11021
        • Arena Oncology Associates
      • New Hyde Park, New York, United States, 11040
        • Long Island Jewish Medical Center
      • Rochester, New York, United States, 14623
        • Upstate NY Cancer Research & Education Foundation, Inc. - Interlakes Oncology/Hematology
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • ACORN - West Cancer Center
    • Texas
      • Austin, Texas, United States, 78705
        • Southwest Regional Cancer Center
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Univ. of Virginia Health System-Cancer Center Clinical Trials Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
open-label, single arm, clinical trial of bendamustine (SDX-105) plus rituximab
Drug: bendamustine and rituximab
Patients will receive rituximab on the first day of a cycle at a dose of 375 mg/m2, followed on the second and third day of a cycle by SDX-105 (bendamustine) at a dose of 90 mg/m2/day of treatment. Four cycles are planned. Patients will receive a dose of rituximab alone 7 days prior to the first cycle of the combination and a dose of rituximab 28 days after the last cycle of the combination. If there is documented disease regression, a fifth and sixth cycle of SDX-105 plus rituximab may be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the objective response rate (ORR = CR + PR) to a regimen of SDX-105 plus rituximab in patients with relapsed indolent or mantle cell non-Hodgkin's lymphoma
Time Frame: 4-6 months
4-6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
• To characterize the safety profile of SDX-105 plus rituximab in this patient population • To determine the one-year and Kaplan-Meier estimates of progression-free survival (PFS) rates • To determine the median duration of response (DR)
Time Frame: 4-6 months
4-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cephalon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

January 20, 2004

First Submitted That Met QC Criteria

January 21, 2004

First Posted (Estimate)

January 22, 2004

Study Record Updates

Last Update Posted (Estimate)

May 9, 2014

Last Update Submitted That Met QC Criteria

May 8, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDX-105-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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