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

  • Interventional
  • Recruiting
  • NCT03181126
Eligibility Details Visit Clinicaltrials.gov

A Phase 1 Dose Escalation, Open-Label Study of Venetoclax in Combination With Navitoclax and Chemotherapy in Subjects With Relapsed/Refractory Acute Lymphoblastic Leukemia or Relapsed/Refractory Lymphoblastic Lymphoma

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.

Gender
All

Age Group
4 Years and up

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - 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.

        Exclusion Criteria:

         - 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 and 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.

At a Glance

National Government IDNCT03181126

IRB#IRB17-0633

Lead SponsorAbbVie

Lead PhysicianWendy Stock

Collaborator(s)N/A

EligibilityAll
4 Years and up
Recruiting