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

Study Identifier
M16-106
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Complete

Results Available

Plain Language Summary
Available Language(s): English
Scientific Result Summary
Available Language(s): English

Study Details

Medical Condition
  • Blood Cancer - Acute Lymphoblastic Leukemia (ALL)
  • Blood Cancer - Lymphoma (General)
  • Study Drug
  • Navitoclax
  • Chemotherapy
  • Venetoclax
  • Phase
    Phase 1
    Sex
    Female & Male
    Age
    4+ years

    Protocol Summary

    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. A safety expansion cohort of approximately 20 patients may be enrolled in addition to the 50 participants in dose-escalation cohort.

    Study Locations

    Location
    Status
    Location
    City of Hope /ID# 169029
    Duarte, California, United States, 91010
    Status
    Not applicable
    Location
    LPCH Stanford /ID# 163337
    Palo Alto, California, United States, 94304
    Status
    Not applicable
    Location
    University of Chicago /ID# 163369
    Chicago, Illinois, United States, 60637
    Status
    Not applicable
    Location
    Washington University-School of Medicine /ID# 165689
    St Louis, Missouri, United States, 63110
    Status
    Not applicable
    Location
    Univ NC Chapel Hill /ID# 163509
    Chapel Hill, North Carolina, United States, 27514-4220
    Status
    Not applicable
    Location
    Cincinnati Children's Hospital /ID# 164619
    Cincinnati, Ohio, United States, 45229
    Status
    Not applicable
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