A Study of Venetoclax in Combination With Navitoclax and Chemotherapy in Subjects With Relapsed/Refractory Acute Lymphoblastic Leukemia or Relapsed/Refractory Lymphoblastic Lymphoma
NCT ID: NCT03181126
Last Updated: 2021-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
69 participants
INTERVENTIONAL
2017-11-27
2020-11-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Navitoclax
tablet
Chemotherapy
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
tablet
Interventions
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Navitoclax
tablet
Chemotherapy
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
tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants with ALL with Philadelphia chromosome or with an ABL class targetable fusion are eligible.
* Participants with LL must have radiographic evidence of disease
* Participants \<= 18 years of age who do not have a standard of care treatment option available.
* Must weigh greater than or equal to 20 kg.
* Must be able to swallow pills.
* Must have adequate hepatic and kidney function.
* Must have adequate performance status:
* Participants less than or equal to 16 years of age: Lansky greater than or equal to 50
* Participants greater than 16 years of age: Karnofsky greater than or equal to 50 or Eastern Cooperative Oncology Group (ECOG) less than 3.
Exclusion Criteria
* Participants who are less than 100 days post-transplant, or greater than 100 days post-transplant with active graft versus host disease (GVHD), or are still continuing post-transplant immunosuppressant therapy within 7 days prior to the first dose of study drug.
* Participants who have received any of the following prior to the first dose of study drug:
* Inotuzumab within 30 days (if participant received inotuzumab \> 30 days prior to Day 1, must have ALT, AST and bilirubin \< ULN).
* A biologic agent (i.e., monoclonal antibodies) for anti-neoplastic intent within 30 days
* CAR-T infusion or other cellular therapy within 30 days
* Any anti-cancer therapy including blinatumomab, chemotherapy, radiation therapy targeted small molecule agents or investigational agents within 14 days, or 5 half-lives, whichever is shorter
* Exception: Philadelphia Chromosome (Ph)+ ALL subjects on TKIs at Screening may enroll and remain on Tyrosine Kinase Inhibitor (TKI) therapy to control disease. Participants on venetoclax at screening may enroll and remain on venetoclax.
* Steroid therapy for anti-neoplastic intent within 5 days
* Hydroxyurea that is ongoing (hydroxyurea is permitted up to the first dose)
* A strong or moderate CYP3A inhibitor or inducer within 7 days
* Aspirin within 7 days, or 5 half-lives, whichever is longer
* An excluded antiplatelet/anticoagulant drug or a herbal supplement that affects platelet function within 7 days, or 5 half-lives, whichever is longer
* Participants with malabsorption syndrome or any other condition that precludes enteral administration.
4 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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AbbVie Inc.
Role: STUDY_DIRECTOR
AbbVie
Locations
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City of Hope /ID# 169029
Duarte, California, United States
LPCH Stanford /ID# 163337
Palo Alto, California, United States
University of Chicago /ID# 163369
Chicago, Illinois, United States
Washington University-School of Medicine /ID# 165689
St Louis, Missouri, United States
Univ NC Chapel Hill /ID# 163509
Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital /ID# 164619
Cincinnati, Ohio, United States
Nationwide Childrens Hospital /ID# 163372
Columbus, Ohio, United States
Oregon Health and Science University /ID# 165690
Portland, Oregon, United States
St Jude Children's Research Hospital /ID# 163335
Memphis, Tennessee, United States
UT Southwestern Medical Center /ID# 163346
Dallas, Texas, United States
MD Anderson Cancer Center at Texas Medical Center /ID# 163327
Houston, Texas, United States
University of Wisconsin-Madiso /ID# 165691
Madison, Wisconsin, United States
Alfred Hospital /ID# 169576
Melbourne, Victoria, Australia
Victorian Comprehensive Cancer /ID# 165710
Melbourne, Victoria, Australia
Royal Children's Hospital /ID# 163322
Melbourne, Victoria, Australia
Countries
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References
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Badawi M, Gopalakrishnan S, Engelhardt B, Palenski T, Karol SE, Rubnitz JE, Menon R, Salem AH. Dosing of Venetoclax in Pediatric Patients with Relapsed Acute Myeloid Leukemia: Analysis of Developmental Pharmacokinetics and Exposure-Response Relationships. Clin Ther. 2024 Oct;46(10):759-767. doi: 10.1016/j.clinthera.2024.09.008. Epub 2024 Oct 5.
Related Links
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clinical study report synopsis
Other Identifiers
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M16-106
Identifier Type: -
Identifier Source: org_study_id