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

Primary Purpose

Non-Hodgkin's Lymphoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
bendamustine and rituximab
Sponsored by
Cephalon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring Non-Hodgkin's Lymphoma, NHL, Rituxan, Mantle Cell, mabs

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alaska Cancer Research and Education Center
  • Bay Area Cancer Research Group
  • Wilshire Oncology Medical Group
  • USC/Kenneth Norris Jr. Cancer Hospital and Research Institute
  • San Diego Cancer Center
  • Hematology Oncology, P.C. Carl and Dorothy Bennett Cancer Center
  • Georgetown University Medical Center - Lombardi Cancer Center
  • Pasco Hernando Oncology
  • John B. Amos Cancer Center
  • Suburban Hematology & Oncology Associates
  • Georgia Oncology Partners Research and Education Foundation
  • Northern Indiana Cancer Research Consortium
  • Oncology and Hematology
  • LSU Health Sciences Center
  • Beth Israel/Deaconess Medical Center
  • University of Michigan Comprehensive Cancer Center
  • Hubert H. Humphrey Cancer Center
  • The Cancer Institute of New Jersey
  • Arena Oncology Associates
  • Long Island Jewish Medical Center
  • Upstate NY Cancer Research & Education Foundation, Inc. - Interlakes Oncology/Hematology
  • ACORN - West Cancer Center
  • Southwest Regional Cancer Center
  • Baylor University Medical Center
  • Univ. of Virginia Health System-Cancer Center Clinical Trials Office
  • Peter MacCallum Cancer Institute
  • Royal Melbourne Hospital
  • St. Vincent's Hospital
  • Westmead Hospital
  • Queen Elizabeth II Health Sciences Centre-Victoria General Site
  • The Royal Victoria Hospital Cancer Care Program Clinical Trials
  • Ottawa Hospital Research Institute
  • North Eastern Ontario Regional Cancer Center
  • Hopital Notre-Dame Du Chum

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

• 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)

Full Information

First Posted
January 20, 2004
Last Updated
May 8, 2014
Sponsor
Cephalon
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1. Study Identification

Unique Protocol Identification Number
NCT00076349
Brief Title
SDX-105 in Combination With Rituxan for Patients With Relapsed Indolent or Mantle Cell Non-Hodgkin's Lymphoma (NHL)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cephalon

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma
Keywords
Non-Hodgkin's Lymphoma, NHL, Rituxan, Mantle Cell, mabs

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
open-label, single arm, clinical trial of bendamustine (SDX-105) plus rituximab
Intervention Type
Drug
Intervention Name(s)
bendamustine and rituximab
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
• 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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Alaska Cancer Research and Education Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Bay Area Cancer Research Group
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Wilshire Oncology Medical Group
City
La Verne
State/Province
California
ZIP/Postal Code
91750
Country
United States
Facility Name
USC/Kenneth Norris Jr. Cancer Hospital and Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
San Diego Cancer Center
City
Vista
State/Province
California
ZIP/Postal Code
92081
Country
United States
Facility Name
Hematology Oncology, P.C. Carl and Dorothy Bennett Cancer Center
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902-3628
Country
United States
Facility Name
Georgetown University Medical Center - Lombardi Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Pasco Hernando Oncology
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
John B. Amos Cancer Center
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31902
Country
United States
Facility Name
Suburban Hematology & Oncology Associates
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30045
Country
United States
Facility Name
Georgia Oncology Partners Research and Education Foundation
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Northern Indiana Cancer Research Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Oncology and Hematology
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006-2921
Country
United States
Facility Name
LSU Health Sciences Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Beth Israel/Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Hubert H. Humphrey Cancer Center
City
Robbinsdale
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
The Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Arena Oncology Associates
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Upstate NY Cancer Research & Education Foundation, Inc. - Interlakes Oncology/Hematology
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
ACORN - West Cancer Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Southwest Regional Cancer Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Univ. of Virginia Health System-Cancer Center Clinical Trials Office
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Peter MacCallum Cancer Institute
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
8006
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
St. Vincent's Hospital
City
Darlinghurst
ZIP/Postal Code
NSW 2010
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
ZIP/Postal Code
NSW 2145
Country
Australia
Facility Name
Queen Elizabeth II Health Sciences Centre-Victoria General Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
The Royal Victoria Hospital Cancer Care Program Clinical Trials
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6M2
Country
Canada
Facility Name
Ottawa Hospital Research Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
North Eastern Ontario Regional Cancer Center
City
Sudbury, ,
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada
Facility Name
Hopital Notre-Dame Du Chum
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4MI
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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