A Study of Venetoclax in Combination With Navitoclax and Chemotherapy in Subjects With Relapsed/Refractory Acute Lymphoblastic Leukemia or Relapsed/Refractory Lymphoblastic Lymphoma
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AbbVie
Age
4–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
Clareo Health | A Study of Venetoclax in Combination With Navitoclax and Chemotherapy in Subjects With Relapsed/Refractory Acute Lymphoblastic Leukemia or Relapsed/Refractory Lymphoblastic Lymphoma
