A Study of Venetoclax in Combination With Navitoclax and Chemotherapy in Subjects With Relapsed/Refractory Acute Lymphoblastic Leukemia or Relapsed/Refractory Lymphoblastic Lymphoma
Status: | Recruiting |
---|---|
Conditions: | Blood Cancer, Lymphoma, Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 4 - Any |
Updated: | 3/17/2019 |
Start Date: | November 27, 2017 |
End Date: | June 17, 2020 |
Contact: | ABBVIE CALL CENTER |
Email: | abbvieclinicaltrials@abbvie.com |
Phone: | 847.283.8955 |
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.
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.
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
- 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
- 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.
We found this trial at
13
sites
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660 South Euclid Avenue
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
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