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

PHASE2CompletedINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

April 30, 2004

Primary Completion Date

December 31, 2005

Study Completion Date

March 31, 2008

Conditions
Non-Hodgkin's Lymphoma
Interventions
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.

Trial Locations (34)

3050

Royal Melbourne Hospital, Parkville

8006

Peter MacCallum Cancer Institute, East Melbourne

11021

Arena Oncology Associates, Great Neck

11040

Long Island Jewish Medical Center, New Hyde Park

14623

Upstate NY Cancer Research & Education Foundation, Inc. - Interlakes Oncology/Hematology, Rochester

20007

Georgetown University Medical Center - Lombardi Cancer Center, Washington D.C.

22908

Univ. of Virginia Health System-Cancer Center Clinical Trials Office, Charlottesville

30045

Suburban Hematology & Oncology Associates, Lawrenceville

31201

Georgia Oncology Partners Research and Education Foundation, Macon

31902

John B. Amos Cancer Center, Columbus

34652

Pasco Hernando Oncology, New Port Richey

38120

ACORN - West Cancer Center, Memphis

46601

Northern Indiana Cancer Research Consortium, South Bend

48109

University of Michigan Comprehensive Cancer Center, Ann Arbor

55422

Hubert H. Humphrey Cancer Center, Robbinsdale

71103

LSU Health Sciences Center, Shreveport

75246

Baylor University Medical Center, Dallas

78705

Southwest Regional Cancer Center, Austin

90033

USC/Kenneth Norris Jr. Cancer Hospital and Research Institute, Los Angeles

91750

Wilshire Oncology Medical Group, La Verne

92081

San Diego Cancer Center, Vista

94520

Bay Area Cancer Research Group, Concord

99508

Alaska Cancer Research and Education Center, Anchorage

06902-3628

Hematology Oncology, P.C. Carl and Dorothy Bennett Cancer Center, Stamford

70006-2921

Oncology and Hematology, Metairie

02215

Beth Israel/Deaconess Medical Center, Boston

08903

The Cancer Institute of New Jersey, New Brunswick

NSW 2010

St. Vincent's Hospital, Darlinghurst

NSW 2145

Westmead Hospital, Westmead

B3H 2Y9

Queen Elizabeth II Health Sciences Centre-Victoria General Site, Halifax

L4M 6M2

The Royal Victoria Hospital Cancer Care Program Clinical Trials, Barrie

P3E 5J1

North Eastern Ontario Regional Cancer Center, Greater Sudbury

K1H 8L6

Ottawa Hospital Research Institute, Ottawa

H2L 4MI

Hopital Notre-Dame Du Chum, Montreal

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Cephalon

INDUSTRY