A Study of Venetoclax in Combination With Navitoclax and Chemotherapy in Subjects With Relapsed/Refractory Acute Lymphoblastic Leukemia or Relapsed/Refractory Lymphoblastic Lymphoma

Part of paid clinical trials in Duarte, California.

Sponsor
AbbVie
Study ID
NCT03181126
Phase
PHASE1
Status
Completed

Conditions

  • Acute Lymphoblastic Leukemia (ALL)
  • Lymphoblastic Lymphoma

Eligibility Criteria

Sex
ALL
Age
4 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Navitoclax — DRUG
    tablet
  • Chemotherapy — DRUG
    peg-asparaginase (or other form of asparaginase, per local standard of care (intravenous) + vincristine (intravenous) + dexamethasone (oral) + tyrosine kinase inhibitor (TKI) (if applicable, oral)
  • Venetoclax — DRUG
    tablet

Study Details

This dose-escalating study is to determine the safety, pharmacokinetics, and preliminary efficacy of venetoclax in combination with navitoclax and chemotherapy in adult and pediatric participants with relapsed/refractory acute lymphoblastic leukemia (ALL) or relapsed/refractory lymphoblastic lymphoma. A safety expansion cohort of approximately 20 patients may be enrolled in addition to the 50 participants in dose-escalation cohort.

Key Dates

Start date
Nov 27, 2017
Status verified
Oct 2021
Primary completion
Nov 11, 2020
Completion
Nov 14, 2020

Study Design

Enrollment
69 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Venetoclax + Navitoclax + Chemotherapy
    Venetoclax weight-adjusted doses administered orally every day (QD) starting on Day 1 + navitoclax various, weight-adjusted doses administered orally QD starting on Day 3 + chemotherapy (peg-asparaginase \[or any other forms of asparaginase\], vincristine, dexamethasone) and tyrosine kinase inhibitor \[TKI, if applicable\]). This regimen and any of its components may be delayed, reduced or omitted at the discretion of the Investigator.

Primary Outcome Measure

Cmax of Venetoclax + Navitoclax [ Time Frame: Up to approximately 9 months ]

Locations (12)

FacilityCityStateZIPSite coordinators
City of Hope /ID# 169029DuarteCalifornia91010-
LPCH Stanford /ID# 163337Palo AltoCalifornia94304-
University of Chicago /ID# 163369ChicagoIllinois60637-
Washington University-School of Medicine /ID# 165689St LouisMissouri63110-
Univ NC Chapel Hill /ID# 163509Chapel HillNorth Carolina27514-4220-
Cincinnati Children's Hospital /ID# 164619CincinnatiOhio45229-
Nationwide Childrens Hospital /ID# 163372ColumbusOhio43205-
Oregon Health and Science University /ID# 165690PortlandOregon97239-
St Jude Children's Research Hospital /ID# 163335MemphisTennessee38105-
UT Southwestern Medical Center /ID# 163346DallasTexas75390-7208-
MD Anderson Cancer Center at Texas Medical Center /ID# 163327HoustonTexas77030-4000-
University of Wisconsin-Madiso /ID# 165691MadisonWisconsin53705-

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CALPCH Stanford· Palo Alto, CAUniversity of Chicago· Chicago, ILWashington University-School of Medicine· St Louis, MOUniv NC Chapel Hill· Chapel Hill, NCCincinnati Children's Hospital· Cincinnati, OH

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