A Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies

PHASE1CompletedINTERVENTIONAL
Enrollment

143

Participants

Timeline

Start Date

November 8, 2017

Primary Completion Date

April 19, 2023

Study Completion Date

April 19, 2023

Conditions
MalignanciesAcute Lymphoblastic Leukemia (ALL)Acute Myeloid Leukemia (AML)Non-Hodgkin's LymphomaNeuroblastoma
Interventions
DRUG

chemotherapy

Dexamethasone and/or vincristine and/or pegasparaginase OR cytarabine and/or etoposide and/or pegasparaginase; tyrosine kinase inhibitor; cytarabine OR azacitidine OR decitabine; rituximab and/or dexamethasone and/or vincristine; cyclophosphamide and/or topotecan

DRUG

venetoclax

Oral tablet for participants; Tablet for oral suspension (participants who cannot swallow a tablet)

Trial Locations (31)

2031

Sydney Children's Hospital /ID# 163148, Randwick

3052

Royal Children's Hospital /ID# 163104, Parkville

4101

Queensland Children's Hospital /ID# 163146, South Brisbane

5006

Women and Childrens Hospital /ID# 163147, North Adelaide

8032

Kinderspital Zurich - Eleonorenstiftung /ID# 163037, Zurich

13353

Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 161730, Berlin

13385

AP-HM - Hopital de la Timone /ID# 161465, Marseille

19104

Children's Hospital of Philadelphia /ID# 163445, Philadelphia

24105

Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 161729, Kiel

30322

Children's Healthcare of Atlan /ID# 161552, Atlanta

31059

CHU Toulouse - Hôpital des enfants /ID# 163727, Toulouse

38105

St Jude Children's Research Hospital /ID# 163447, Memphis

45147

Universitaetsklinikum Essen /ID# 164207, Essen

45229

Cincinnati Children's Hospital /ID# 161550, Cincinnati

69373

Centre Leon Berard /ID# 163707, Lyon

75012

AP-HP - Hopital Armand-Trousseau /ID# 163728, Paris

75019

Robert Debre Hopital, FR /ID# 161464, Paris

79106

Universitaetsklinikum Freiburg /ID# 164206, Freiburg im Breisgau

80045

Children's Hospital Colorado /ID# 161551, Aurora

84113

Primary Children's /ID# 164399, Salt Lake City

98105

Seattle Children's Hospital /ID# 163459, Seattle

94143-2204

Univ California, San Francisco /ID# 163460, San Francisco

02215

Dana-Farber Cancer Institute /ID# 163440, Boston

10065-6007

Memorial Sloan Kettering Cancer Center-Koch Center /ID# 163444, New York

53226-3522

Medical College of Wisconsin /ID# 163461, Milwaukee

M5G 1X8

Hospital for Sick Children /ID# 163726, Toronto

H3T 1C5

CHU Sainte-Justine /ID# 163725, Montreal

3015 GD

Erasmus MC - Sophia /ID# 161579, Rotterdam

3584 CS

Prinses Maxima Centrum /ID# 162670, Utrecht

WC1N 3JH

Great Ormond Street Hospital for Children /ID# 169238, London

NE7 7DN

The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 162938, Newcastle upon Tyne

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Roche-Genentech

INDUSTRY

lead

AbbVie

INDUSTRY