Clinical trial NCT00076349: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma
Keywords: Non-Hodgkin's Lymphoma
NHL
Rituxan
Mantle Cell
mabs
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2004-01-22
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: 4-6 months
Secondary outcomes:
measure: • 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)
timeFrame: 4-6 months
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Cancer Research and Education Center
state: Alaska
city: Concord
country: United States
facility: Bay Area Cancer Research Group
state: California
city: La Verne
country: United States
facility: Wilshire Oncology Medical Group
state: California
city: Los Angeles
country: United States
facility: USC/Kenneth Norris Jr. Cancer Hospital and Research Institute
state: California
city: Vista
country: United States
facility: San Diego Cancer Center
state: California
city: Stamford
country: United States
facility: Hematology Oncology, P.C. Carl and Dorothy Bennett Cancer Center
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Medical Center - Lombardi Cancer Center
state: District of Columbia
city: New Port Richey
country: United States
facility: Pasco Hernando Oncology
state: Florida
city: Columbus
country: United States
facility: John B. Amos Cancer Center
state: Georgia
city: Lawrenceville
country: United States
facility: Suburban Hematology & Oncology Associates
state: Georgia
city: Macon
country: United States
facility: Georgia Oncology Partners Research and Education Foundation
state: Georgia
city: South Bend
country: United States
facility: Northern Indiana Cancer Research Consortium
state: Indiana
city: Metairie
country: United States
facility: Oncology and Hematology
state: Louisiana
city: Shreveport
country: United States
facility: LSU Health Sciences Center
state: Louisiana
city: Boston
country: United States
facility: Beth Israel/Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Robbinsdale
country: United States
facility: Hubert H. Humphrey Cancer Center
state: Minnesota
city: New Brunswick
country: United States
facility: The Cancer Institute of New Jersey
state: New Jersey
city: Great Neck
country: United States
facility: Arena Oncology Associates
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: Rochester
country: United States
facility: Upstate NY Cancer Research & Education Foundation, Inc. - Interlakes Oncology/Hematology
state: New York
city: Memphis
country: United States
facility: ACORN - West Cancer Center
state: Tennessee
city: Austin
country: United States
facility: Southwest Regional Cancer Center
state: Texas
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Charlottesville
country: United States
facility: Univ. of Virginia Health System-Cancer Center Clinical Trials Office
state: Virginia
city: East Melbourne
country: Australia
facility: Peter MacCallum Cancer Institute
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital
city: Westmead
country: Australia
facility: Westmead Hospital
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre-Victoria General Site
state: Nova Scotia
city: Barrie
country: Canada
facility: The Royal Victoria Hospital Cancer Care Program Clinical Trials
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
city: Sudbury, ,
country: Canada
facility: North Eastern Ontario Regional Cancer Center
state: Ontario
city: Montreal
country: Canada
facility: Hopital Notre-Dame Du Chum
state: Quebec
Study officials:
References: