A Study Of Panobinostat In Children With Refractory Hematologic Malignancies

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

March 31, 2011

Primary Completion Date

October 31, 2015

Conditions
Lymphoblastic Leukemia, Acute, ChildhoodMyelogenous Leukemia, Acute, ChildhoodHodgkin's DiseaseNon-Hodgkin's Lymphoma
Interventions
DRUG

Panobinostat

Dose will be assigned at study entry. Patients will take panobinostat orally 3 times a week given on a Monday, Wednesday, Friday schedule, every week. One course is 28 days (4 weeks). Patients will get 2 courses and may receive up to 8 courses total.

DRUG

Cytarabine

"All patients will receive 70 mg of intrathecal cytarabine on day 0 of course 1. The day 0 dose must be given at least 24 hours prior to initiation of panobinostat. Omit the day 0 dose of intrathecal cytarabine if the patient received intrathecal therapy within 72 hours of treatment.~All patients will receive 70 mg of intrathecal cytarabine on day 29 of course 1-8 in conjunction with their disease evaluation."

DRUG

Panobinostat

Dose will be assigned at study entry. Patients will take panobinostat orally 3 times a week on a Monday, Wednesday, Friday schedule, every other week. Once course is 28 days (4 weeks). Patients will get 2 course and may receive up to 8 courses of therapy.

Trial Locations (20)

10016

New York University Medical Center, New York

10032

Children's Hospital New York-Presbyterian, New York

28203

Levine Children's Hospital at Carolinas Medical Center, Charlotte

33136

University of Miami Cancer Center, Miami

90027

Childrens Hospital Los Angeles, Los Angeles

98105

Seattle Children's Hospital, Seattle

94143-0106

UCSF School of Medicine, San Francisco

Unknown

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

Children's Healthcare of Atlanta, Emory University, Atlanta

Lurie Children's Hospital, Chicago

Dana Farber, Boston

Rainbow Babies, Cleveland

Nationwide Childrens Hospital, Columbus

Oregon Health and Science University, Portland

Vanderbilt Children's Hospital, Nashville

Primary Children's, Salt Lake City

Medical College of Wisconsin, Milwaukee

48109-0914

C.S. Mott Children's Hospital, Ann Arbor

55404-4597

Childrens Hospital & Clinics of Minnesota, Minneapolis

38105-3678

St. Jude, Memphis

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

Therapeutic Advances in Childhood Leukemia Consortium

OTHER

NCT01321346 - A Study Of Panobinostat In Children With Refractory Hematologic Malignancies | Biotech Hunter | Biotech Hunter