Vincristine Sulfate Liposome Injection (Marqibo®) in Combination With UK ALL R3 Induction Chemotherapy

PHASE1CompletedINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

January 31, 2017

Primary Completion Date

July 29, 2022

Study Completion Date

December 31, 2024

Conditions
ALL, ChildhoodLymphoblastic Leukemia, Acute, ChildhoodLymphoblastic Leukemia, Acute
Interventions
DRUG

Marqibo

The focus of the study design and statistical analysis is to determine whether Marqibo® can be substituted for standard vincristine and successfully administered to patients with relapsed ALL in three different treatment cohorts: (A) treatment with the UK ALL R3 regimen; (B) treatment with UK ALL R3 regimen without mitoxantrone, and (C) treatment with ALL maintenance therapy. Secondary objectives include estimating rates of serious toxicities and therapy delays in each of these cohorts.

Trial Locations (35)

2031

Sydney Children's Hospital, Randwick

2145

The Children's Hospital at Westmead, Westmead

3052

Royal Children's Hospital, Melbourne, Parkville

4101

Lady Cilento Children's Hospital, South Brisbane

10032

Children's Hospital New York-Presbyterian, New York

19104

Children's Hospital of Philadelphia, Philadelphia

20010

Children's National Medical Center, Washington D.C.

20892

National Cancer Institute, Pediatric Oncology Branch, Bethesda

21231

Sidney Kimmel Cancer Center at Johns Hopkins, Baltimore

28203

Levine Children's Hospital, Charlotte

30322

Children's Healthcare of Atlanta at Egleston, Atlanta

33136

University of Miami, Miami

33701

All Children's Hospital, St. Petersburg

37232

Monroe Carell Jr. Children's Hospital at Vanderbilt, Nashville

43205

Nationwide Children's Hospital, Columbus

44106

Rainbow Babies & Children's Hospital, Cleveland

45229

Cincinnati Children's Hospital, Cincinnati

48109

CS Mott Children's Hospital, Ann Arbor, Ann Arbor

53226

Medical College of Wisconsin, Milwaukee

55404

Children's Hospitals and Clinics of Minnesota, Minneapolis

60611

Lurie Children's Hospital of Chicago, Chicago

75235

University of Texas Southwestern Medical Center, Dallas

76104

Cook Children's Medical Center, Fort Worth

77030

Texas Children's Cancer Center, Baylor, Houston

80045

The Children's Hospital, University of Colorado, Aurora

84113

Primary Children's Hospital, Salt Lake City

90027

Childrens Hospital Los Angeles, Los Angeles

92868

Children's Hospital Orange County, Orange

94158

UCSF School of Medicine, San Francisco

97239

Oregon Health & Science University, Portland

98105

Seattle Children's Hospital, Seattle

02215

Dana-Farber Cancer Institute, Boston

V6H 3V4

British Columbia Children's Hospital, Vancouver

M5G 1X8

Hospital for Sick Children, Toronto

H3T-1C5

Sainte-Justine University Hospital Center, Montréal, Québec

All Listed Sponsors
collaborator

Spectrum Pharmaceuticals, Inc

INDUSTRY

lead

Therapeutic Advances in Childhood Leukemia Consortium

OTHER

NCT02879643 - Vincristine Sulfate Liposome Injection (Marqibo®) in Combination With UK ALL R3 Induction Chemotherapy | Biotech Hunter | Biotech Hunter