Palbociclib in Combination With Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL)

PHASE1CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

April 11, 2019

Primary Completion Date

June 30, 2021

Study Completion Date

September 30, 2023

Conditions
Leukemia, LymphocyticLymphoblastic LymphomaT-cell LymphomaT-cell LeukemiaRecurrent DiseaseAcute Leukemia
Interventions
DRUG

Palbociclib

Given PO (or via NG- tube)

DRUG

Cytarabine

Given intrathecally (IT)

DRUG

Methotrexate

Given intrathecally (IT)

DRUG

Hydrocortisone

Given IT

DRUG

Doxorubicin

Given intravenously (IV)

DRUG

Prednisolone

Either prednisone or prednisolone is given PO

DRUG

Vincristine

Given IV

DRUG

Pegaspargase

Given IV

DRUG

Hydrocortisone

Given intrathecally (IT)

DRUG

Prednisone

Either prednisone or prednisolone is given PO

Trial Locations (19)

10016

Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York

10032

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York

15224

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

19104

Children's Hospital of Philadelphia, Philadelphia

20010

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

30322

Children's Healthcare of Atlanta - Egleston, Atlanta

35233

Children's Hospital of Alabama, Birmingham

38105

Saint Jude Children's Research Hospital, Memphis

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

46202

Riley Hospital for Children, Indianapolis

48109

C S Mott Children's Hospital, Ann Arbor

55455

University of Minnesota/Masonic Cancer Center, Minneapolis

73104

University of Oklahoma Health Sciences Center, Oklahoma City

80045

Children's Hospital Colorado, Aurora

84113

Primary Children's Hospital, Salt Lake City

92354

Loma Linda University Medical Center, Loma Linda

92868

Children's Hospital of Orange County, Orange

94304

Lucile Packard Children's Hospital Stanford University, Palo Alto

98105

Seattle Children's Hospital, Seattle

All Listed Sponsors
lead

Children's Oncology Group

NETWORK

NCT03792256 - Palbociclib in Combination With Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL) | Biotech Hunter | Biotech Hunter