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

Non-Hodgkin's Lymphoma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00076349
• Other study ID #: SDX-105-02
• Status: Completed
• Phase: Phase 2
• First received: January 20, 2004
• Last updated: May 8, 2014
• Start date: April 2004
• Est. completion date: March 2008

Study information

• Verified date: May 2014
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: March 2008
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Cephalon

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		4-6 months	No
Secondary	• 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)		4-6 months	Yes