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

Sponsor

Cephalon (Industry)

Overall Status

Completed

CT.gov ID

NCT00076349

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

1.9

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Hodgkin's Lymphoma	Drug: bendamustine and rituximab	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

66 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Apr 1, 2004

Actual Primary Completion Date :

Dec 1, 2005

Actual Study Completion Date :

Mar 1, 2008

Arms and Interventions

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.

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.

Outcome Measures

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 [4-6 months]

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) [4-6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

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