Phase III Study of CPX-351 Versus 7+3 in Patients 60-75 Years Old With Untreated High Risk (Secondary) Acute Myeloid Leukemia

PHASE3CompletedINTERVENTIONAL
Enrollment

309

Participants

Timeline

Start Date

December 13, 2012

Primary Completion Date

December 31, 2015

Study Completion Date

December 31, 2015

Conditions
High Risk Acute Myeloid Leukemia
Interventions
DRUG

CPX-351

First induction: 100 units/m2 by 90-minute IV infusion on Days 1, 3, 5. Second induction: 100 units/m2 by 90-minute IV infusion on Days 1 and 3. Consolidation therapy: 65 units/m2 by 90-minute IV infusion on Days 1 and 3.

DRUG

7+3 (cytarabine and daunorubicin)

"First induction: 7+3 was administered as: cytarabine at a dose of 100 mg/m2/day on Days 1 through 7 by continuous infusion, and daunorubicin at a dose of 60 mg/m2/day on Days 1, 2, and 3.~Second induction: 5+2 was administered as: cytarabine at a dose of 100 mg/m2/day on Days 1 through 5 by continuous infusion and daunorubicin at a dose of 60 mg/m2/day on Days 1 and 2.~Consolidation therapy: 5+2 was administered as: cytarabine at a dose of 100 mg/m2/day on Days 1 through 5 by continuous infusion, and daunorubicin at a dose of 60 mg/m2/day on Days 1 and 2."

Trial Locations (43)

10032

Columbia University, New York

10065

Cornell U, Weill Medical College, New York

10467

Montefiore Medical Center, The Bronx

10595

New York Medical College, Valhalla

15219

UPMC, Pittsburgh

19111

Fox Chase Cancer Center, Philadelphia

27157

Wake Forest University Health Services, Winston-Salem

27710

Duke University Medical Center, Durham

29425

Medical University of South Carolina, Charleston

30342

Northside Hospital, Atlanta

32611

University of Florida, Gainesville

33612

H. Lee Moffitt Cancer Center, Tampa

35294

University of Alabama at Birmingham, Birmingham

37203

Sarah Cannon Research Institute, Nashville

37232

Vanderbilt University, Nashville

46237

Franciscan St. Francis Health, Indianapolis

48109

University of Michigan, Ann Arbor

53226

Medical College of Wisconsin, Milwaukee

55455

University of Minnesota, Minneapolis

60208

Northwestern University, Chicago

60612

Rush University Medical Center, Chicago

60637

University of Chicago, Chicago

63110

Washington University, St Louis

65211

University of Missouri, Columbia

66160

University of Kansas Medical Center, Kansas City

75246

Baylor Research Insitute, Dallas

90095

UCLA, Los Angeles

94305

Stanford University, Stanford

97213

Providence Portland Medical Center, Portland

97239

Oregon Health and Science University, Portland

98109

Fred Hutchinson Cancer Research Center, Seattle

770303

M.D. Anderson Cancer Center, Houston

92037-0706

University of CA San Diego, San Diego

06510

Yale University, New Haven

02215

Dana-Farber Cancer Institute, Boston

03756

Dartmouth Hitchcock Medical Center, Lebanon

07601

Hackensack University Medical Center, Hackensack

Unknown

North Shore LIJ Health System, Long Island City

Hopital Maisonneuve-Rosemont, Montreal

27599-1651

University of North Carolina at Chapel Hill, Chapel Hill

T6G 2C8

University of Alberta Hospital, Edmonton

V5Z 1M9

British Columbia Cancer Center, Vancouver

M5G2M9

Princess Margaret Hospital, Toronto

Sponsors
All Listed Sponsors
collaborator

The Leukemia and Lymphoma Society

OTHER

lead

Jazz Pharmaceuticals

INDUSTRY