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

Completed · Phase 1

Conditions studied: Acute Lymphoblastic Leukemia (ALL), Lymphoblastic Lymphoma

In brief

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 facts

Study ID

NCT03181126

Run by

AbbVie

People needed

69

Starts

2017-11-27

Expected to finish

2020-11-14

Last updated by the study team

2021-10-14

Who can join

Age: 4 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must have relapsed or refractory acute lymphoblastic leukemia (ALL) or relapsed or refractory lymphoblastic lymphoma (LL). Refractory is defined as persistent disease after at least 2 courses of chemotherapy.
• 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.

You may not qualify if…

• Participant has central nervous system (CNS) disease with cranial involvement that requires radiation.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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