A Study of Venetoclax in Combination With Navitoclax and Chemotherapy in Subjects With Relapsed/Refractory Acute Lymphoblastic Leukemia or Relapsed/Refractory Lymphoblastic Lymphoma
- Conditions
- Acute Lymphoblastic Leukemia (ALL)Lymphoblastic LymphomaTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-001541-26-Outside-EU/EEA
- Lead Sponsor
- AbbVie Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- Not specified
nclusion Criteria:
a) 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
b) Participants <= 18 years of age who do not have a standard of care treatment option available.
c) Must weigh greater than or equal to 20 kg.
d) Must be able to swallow pills.
e) Must have adequate hepatic and kidney function.
f) 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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 18
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6
a) Participant has central nervous system (CNS) disease with cranial involvement that requires radiation.
b) 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.
c) 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
d) 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
e) Participants with malabsorption syndrome or any other condition that precludes enteral administration
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method