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

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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.


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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Dallas, TX
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Chapel Hill, North Carolina 27514
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Chapel Hill, NC
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924 East 57th Street
Chicago, Illinois 60637
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Chicago, IL
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Cincinnati, OH
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700 Children's Drive
Columbus, Ohio 43205
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Columbus, OH
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Duarte, California 91010
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Duarte, CA
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Houston, TX
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Madison, WI
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Melbourne, Victoria
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Melbourne,
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Memphis, Tennessee 38105
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Memphis, TN
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725 Welch Road
Palo Alto, California 94304
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Palo Alto, CA
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from
Portland, OR
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660 South Euclid Avenue
Saint Louis, Missouri 63110
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from
Saint Louis, MO
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