A Study Assessing Adverse Event and How Oral ABBV-453 Moves Through the Body in Adult Participants With Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Study Identifier
M24-291
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
2023-507637-19
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Study Details

Medical Condition
  • Blood Cancer - Chronic Lymphocytic Leukemia (CLL)
  • Blood Cancer - Small Lymphocytic Lymphoma (SLL)
  • Study Drug
  • Obinutuzumab
  • ABBV-453
  • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    Chronic lymphocytic leukemia (CLL) is the most common leukemia in Western countries. The purpose of this study is to assess how well ABBV-453 works adult participants with relapsed/refractory (R/R) untreated CLL/small lymphocytic lymphoma (SLL). Adverse events, pharmacokinetics, and change in disease activity will be assessed.

    ABBV-453 is an investigational drug for the treatment of CLL and SLL. Participants will be enrolled with a specific target dose and receive obinutuzumab during the debulking period followed escalating doses of ABBV-453, until the appropriate target dose is achieved. Approximately 60 adult participants with previously R/R CLL/SLL will be enrolled in the study in approximately 40 sites across the world.

    Participants will receive intravenous (IV) obinutuzumab as part of the debulking period, followed by escalating doses of oral ABBV-453 until the appropriate target dose is achieved. The estimated study duration is 3 years.

    There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.

    Study Locations

    Location
    Status
    Location
    City of Hope /ID# 253904
    Duarte, California, United States, 91010
    Status
    Not applicable
    Location
    City of Hope - Orange County Lennar Foundation Cancer Center /ID# 267158
    Irvine, California, United States, 92618
    Status
    Not applicable
    Location
    Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 264622
    Billings, Montana, United States, 59102
    Status
    Not applicable
    Location
    Atrium Health /ID# 265136
    Charlotte, North Carolina, United States, 28204-2963
    Status
    Not applicable
    Location
    Duplicate_Duke Cancer Center /ID# 258707
    Durham, North Carolina, United States, 27710-3000
    Status
    Not applicable
    Location
    MD Anderson Cancer Center /ID# 253713
    Houston, Texas, United States, 77030
    Status
    Not applicable
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