Study to Evaluate Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-291 Moves Through the Body in Adult Participants With Non-Hodgkin's Lymphoma

StatusActive, Not Recruiting
PhasePhase 1
SponsorAbbVie
Started

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Trial flagged as At Risk
Enrollment reduced 87% 165 → 21 participants
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Record History

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  1. Primary completion moved earlier from Apr 2027 to Jan 2027 Show 4 more changesShow less
    • Study completion pushed from Apr 2027 to Nov 2031
    • Eligibility criteria expanded, about 25 words
    • Secondary endpoints: details revised at 3 of 7 entries
    • Study sites revised (14)
  2. Enrollment reduced: 165 → 21 participantsv11 Show 4 more changesShow less
    • Enrollment closed, study ongoing
    • Primary completion pushed from Jan 2027 to Apr 2027
    • Study completion moved earlier from Nov 2031 to Apr 2027
    • Site details revised at 14 of 14 sites
  3. Site details revised at 1 of 14 sitesv10
  4. Primary completion date: Nov 2031 to Jan 2027
    • Study sites: 10 to 14
    v9
  5. Study sites: 9 to 10v8
Show 6 earlier versionsHide 6 earlier versions
  1. Study sites: 8 to 9v7
  2. Study sites: 7 to 8v6
  3. Study sites: 6 to 7v5
  4. Start date changed from estimate of Jan 29, 2025 to Jan 16, 2025v4
  5. Study sites: 4 to 6v3
  6. Study sites: 3 to 4
    • Primary and study completion dates: Nov 1, 2031 to Nov 2031
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
AbbVie
349 trials monitored
See 27 trials at risk
Non-Hodgkin Lymphoma
2,017 trials monitored
See 114 trials at risk
DLBCL
706 trials monitored
See 46 trials at risk
Follicular Lymphoma
347 trials monitored
See 28 trials at risk
and 1 more disease
Non-Hodgkin's lymphoma (NHL) is a cancer that arises from the transformation of normal B and T lymphocytes (white blood cells). The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of ABBV-291 in adult participants in relapsed or refractory (R/R) NHL, including but not limited to diffuse large b-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), and follicular lymphoma (FL). Adverse events will be assessed. ABBV-291 is an investigational drug being developed for the treatment of NHL. This study will include a dose escalation phase to determine the maximum administered dose (MAD)/Maximum tolerated dose (MTD) of ABBV-291 and a dose expansion/optimization phase to determine the change in disease activity in participants with R/R NHL. Approximately 165 adult participants with multiple NHL subtypes will be enrolled in the study in sites world wide In the dose escalation phase of the study participants will receive escalating Intravenously (IV) infused doses of ABBV-291, until the MAD/MTD is determined. In the dose expansion/optimization phase of the study participants receive IV infused ABBV-291, as part of the approximately 74 month study duration. 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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, and side effects.
Trial Details
NCT Number NCT06667687
Lead Sponsor AbbVie
Conditions
(from sponsor)		 Non-Hodgkin's Lymphoma
Related terms Lymphoma, B-Cell, Marginal Zone, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell, Lymphoma, Non-Hodgkin, Neoplasms
Enrollment 21 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov