CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 143 enrolled
Drug / intervention
chemotherapy +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03236857
NCT03236857Phase 1Completed
CompareCT.gov

A Phase 1 Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies

AbbVie·interventional·Posted Aug 2, 2017·Updated May 22, 2023

In Brief

A Phase 1 clinical trial evaluating chemotherapy and venetoclax for Malignancies and 4 related conditions. Completed, enrolled 143 participants across 31 sites in 8 countries.

Detailed Summary

An open-label, global, multi-center study to evaluate the safety and pharmacokinetics of venetoclax monotherapy, to determine the dose limiting toxicity (DLT) and the recommended Phase 2 dose (RPTD), and to assess the preliminary efficacy of venetoclax in pediatric and young adult participants with relapsed or refractory malignancies.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalignancies, Acute Lymphoblastic Leukemia (ALL), Acute Myeloid Leukemia (AML), Non-Hodgkin's Lymphoma, Neuroblastoma
CountriesAustralia, Canada, France, Germany, Netherlands, Switzerland, United Kingdom, United States
CollaboratorsRoche-Genentech

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedAug 2, 2017
Enrollment StartNov 8, 2017
Primary CompletionApr 19, 2023
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 8.9 years ago

Interventions

chemotherapydrug

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

venetoclaxdrug

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