Trial Search Results

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

This is an open-label, global, multi-center Phase 1 dose escalation study of venetoclax in combination with navitoclax. The study is being conducted to determine the safety, pharmacokinetics, and preliminary efficacy of venetoclax in combination with navitoclax and chemotherapy in adult and pediatric subjects with relapsed acute lymphoblastic leukemia (ALL).

Stanford is currently accepting patients for this trial.

Lead Sponsor:

AbbVie

Stanford Investigator(s):

Intervention(s):

  • Drug: Navitoclax
  • Drug: Chemotherapy
  • Drug: Venetoclax

Phase:

Phase 1

Eligibility


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.

Ages Eligible for Study

4 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Christopher Le
650-725-4318
Recruiting