Safety and Efficacy of Treanda™ (Bendamustine HCl) in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Who Are Refractory to Rituximab

Sponsor

Cephalon (Industry)

Overall Status

Completed

CT.gov ID

NCT00139841

Collaborator

(none)

103

Enrollment

Locations

Arm

Duration (Months)

2.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

SUMMARY: This is a multi-center open label study to evaluate the safety and effectiveness of Treanda™ (also known as bendamustine HCl or SDX-105) in patients who have indolent Non-Hodgkin's lymphoma and have relapsed within a defined timeframe after taking rituximab (Rituxan®). Treanda will be given via 60-minute intravenous infusion on days 1 and 2 of every 21-day treatment cycle. Patients will be treated for 6 cycles unless they develop progressive disease or unacceptable toxicity. Those who continue to receive clinical benefit at end of 6 cycles may receive an additional 2 cycles. Following the end of treatment, patients will be followed for up to 2 years until disease progression or start of another anti-cancer therapy.

Condition or Disease	Intervention/Treatment	Phase
Non-Hodgkin's Lymphoma	Drug: Bendamustine HCl	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

103 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Multi-Center Phase III Study to Investigate the Safety and Efficacy of Treanda™ (Bendamustine HCl) in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Who Are Refractory to Rituximab

Study Start Date :

Oct 1, 2005

Actual Primary Completion Date :

Jul 1, 2007

Actual Study Completion Date :

Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 bendamustine	Drug: Bendamustine HCl Dose of 120 mg/m2 on Day 1 and Day 2 of each treatment cycle (every 21 days). Patients who are continuing to experience clinical benefit at Cycle 6, as assessed by the investigator, may receive up to 2 additional cycles, to a maximum of 8 cycles.

Arm

Intervention/Treatment

Experimental: 1

bendamustine

Drug: Bendamustine HCl

Dose of 120 mg/m2 on Day 1 and Day 2 of each treatment cycle (every 21 days). Patients who are continuing to experience clinical benefit at Cycle 6, as assessed by the investigator, may receive up to 2 additional cycles, to a maximum of 8 cycles.

Outcome Measures

Primary Outcome Measures

Assess the overall response rate (ORR = CR + CRu + PR) and duration of response (DR) to a regimen of bendamustine in patients who are refractory to rituximab therapy. [6 months]

Secondary Outcome Measures

• assess the safety profile of Treanda in this patient population. • assess the duration of progression-free survival (PFS). • estimate the basic pharmacokinetic parameters • assess the effects of plasma concentrations [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

ELIGIBILITY:

Key Inclusion Criteria

Documented B-cell Non-Hodgkin's Lymphoma
Small lymphocytic lymphoma (ALC < 5,000 cells/mm3)
Marginal zone B-cell lymphoma (nodal, extranodal, or splenic types)
Lymphoplasmacytic lymphoma
Follicular center lymphoma, follicular

Disease documented to be refractory to a full-course of the most recent rituximab therapy (single agent or combination)

At least 1 prior chemotherapy regimen and maximum of 3 prior chemotherapy regimens
Bidimensionally measurable disease (by CT scan) with at least one lesion measuring ≥ 2.0 cm in a single dimension

Key Exclusion Criteria

Patients who receive rituximab only as part of treatment with ibritumomab tiuxetan (Zevalin®) will not be eligible
History of prior high dose chemotherapy with allogeneic stem cell support (history of autologous stem cell support is permissible)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama Birmingham	Birmingham	Alabama	United States	35233
2	Arizona Cancer Center	Tucson	Arizona	United States	85724
3	Alta Bates Comprehensive Cancer Center	Berkeley	California	United States	94704
4	Tower Hematology and Oncology Medical Group	Beverly Hills	California	United States	90211
5	Moores UCSD Cancer Center	La Jolla	California	United States	92093
6	USC/Norris Cancer Hospital	Los Angeles	California	United States	90033
7	Comprehensive Cancer Center - Desert Regional Medical Center	Palm Springs	California	United States	92662
8	Stanford University Division of Oncology	Stanford	California	United States	94305
9	University of Colorado Cancer Center	Aurora	Colorado	United States	80010
10	Yale University School of Medicine	New Haven	Connecticut	United States	06520
11	Georgetown University Medical Center	Washington	District of Columbia	United States	20007
12	Rush University Medical Center	Chicago	Illinois	United States	60612
13	Indiana Oncology Hematology Consultants, A Division of AHN	Indianapolis	Indiana	United States	46202
14	Markey Cancer Center, University of Kentucky Medical Center	Lexington	Kentucky	United States	40536
15	LSU Health Sciences Center, Feist Weiller Cancer Center	Shreveport	Louisiana	United States	71130
16	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02115
17	University of Michigan Cancer Center	Ann Arbor	Michigan	United States	48109
18	Henry Ford Health System	Detroit	Michigan	United States	48202
19	Washington University School of Medicine in St. Louis	St. Louis	Missouri	United States	63110
20	Nevada Cancer Institute	Las Vegas	Nevada	United States	89135
21	University of New Mexico Cancer Research and Treatment Center	Albuquerque	New Mexico	United States	87131
22	Roswell Park Cancer Institute	Buffalo	New York	United States	14263
23	Weill Cornell Cancer Care Center	New York	New York	United States	10021
24	Interlakes Foundation, Inc.	Rochester	New York	United States	14623
25	University of Rochester Medical Center, James P. Wilmot Cancer Center	Rochester	New York	United States	14642
26	Duke University School of Medicine	Durham	North Carolina	United States	27710
27	The Cleveland Clinic Foundation Taussig Cancer Center	Cleveland	Ohio	United States	44195
28	The West Clinic/ACORN	Memphis	Tennessee	United States	38138
29	Sarah Cannon Research Institute	Nashville	Tennessee	United States	37203
30	Arlington Cancer Center	Arlington	Texas	United States	76012
31	University of Virginia Cancer Center	Charlottesville	Virginia	United States	22908
32	University of Wisconsin	Madison	Wisconsin	United States	53792
33	Cross Cancer Institute	Edmonton	Alberta	Canada	T6G 1Z2
34	British Columbia Cancer Agency	Vancouver	British Columbia	Canada	V5Z 4E6
35	Queen Elizabeth Health Sciences Centre	Halifax	Nova Scotia	Canada	B3H 1V7
36	Ottawa Hospital - General Campus	Ottawa	Ontario	Canada	KIH8L6
37	Hopital Notre-Dame du CHUM	Montreal	Quebec	Canada	H2: 4M1
38	Hopital du Sacre Couer de Montreal	Montreal	Quebec	Canada	H4J 1C5
39	Saskatchewan Cancer Center Agency	Saskatoon	Saskatchewan	Canada	S7N 4H4
40	Hospital Espanol Auxilio Mutuo, Auxilio Mutuo Cancer Center	San Juan		Puerto Rico	00919