Monitoring and Treatment of Relapsed Leukemia Following Allogeneic Hematopoietic Stem Cell Transplantation in Children

PHASE1TerminatedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

May 31, 2015

Primary Completion Date

May 18, 2018

Conditions
Leukemia
Interventions
DRUG

Bortezomib

1.3 mg/m2/dose subcutaneously (SQ) daily (total 4 doses) on Days 1, 4, 8 and 11 (+/- 1 day with at least 72 hours between doses) q3 weeks. (For patients continuing to receive drug in cycles 6 or greater, at investigator discretion, the schedule may be changed to 1.3 mg/m2/dose SQ daily (total 3 doses) on Days 1, 8, and 15 (+/- 1 day with at least 72 hours between doses) every 4 weeks in an effort to decrease risk of peripheral neuropathy.)

DRUG

Pravastatin

10 mg for age \< 8 years, 20 mg for age 8-\<13 years, 40 mg for ages \>14 years

Trial Locations (1)

20010

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

Sponsors
All Listed Sponsors
collaborator

Millennium Pharmaceuticals, Inc.

INDUSTRY

collaborator

Hyundai Hope On Wheels

OTHER

lead

Reuven Schore

OTHER