A Phase 1-2, Multicenter, Open-Label Study of AEG35156 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia and Indolent B-Cell Lymphomas

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

September 30, 2008

Primary Completion Date

June 30, 2011

Study Completion Date

September 30, 2011

Conditions
Leukemia, Lymphocytic, Chronic, B-CellLymphoma, B-Cell
Interventions
DRUG

AEG35156 antisense IV infusion

"AEG35156 will be given as a 2-hour intravenous infusion (escalating dose 50, 100, 150, 200, 250 and 300 mg) once weekly on Day 1, Day 8 and Day 15. One cycle of therapy will consist of 21 days. Patients will be treated until disease progression.~* Patients must be pretreated for at least three days with allopurinol prior to the first dose of AEG35156 and throughout protocol therapy.~* Patients must be hydrated with 1 L of normal saline prior AEG35156 infusion"

Trial Locations (7)

10595

New York Medical College, Valhalla

44195

The Cleveland Clinic, Taussig Cancer Institute, Cleveland

76508

Scott and White Memorial Hospital, Temple

91505

Providence Saint-Joseph Medical Center, Burbank

T2N 4N2

Tom Baker Cancer Centre, Calgary

M5G 2M9

Princess Margaret Hospital, Toronto

H3T 1E2

Jewish General Hospital - Sir Mortimer B. Davis, Montreal

Sponsors
All Listed Sponsors
collaborator

The Leukemia and Lymphoma Society

OTHER

lead

Aegera Therapeutics

INDUSTRY

NCT00768339 - A Phase 1-2, Multicenter, Open-Label Study of AEG35156 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia and Indolent B-Cell Lymphomas | Biotech Hunter | Biotech Hunter