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NCT05753501

Study to Evaluate Adverse Events, Change in Disease Activity, and How Oral ABBV-101 Moves Through the Body in Adult Participants With B-Cell Malignancies

StatusActive, Not Recruiting
PhasePhase 1
SponsorAbbVie
Primary completion (estimated)
Track this trial

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Record History

All 50 versions: 40 with changes below, 10 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Trial arms changed: 4 → 1 Show 4 more changesShow less
    • Interventions modified
    • Eligibility criteria shortened, about 113 words
    • Secondary endpoints: 8 to 5
    • Study sites revised (51)
  2. Study sites revised (51)v49
  3. Study sites revised (51)v43
  4. Trial arms changed: 3 → 4v38 Show 4 more changesShow less
    • Interventions: ABBV-101 (Drug) to ABBV-101 (Drug), Venetoclax (Drug)
    • Eligibility criteria expanded, about 49 words
    • Secondary endpoints: 5 to 8
    • Study sites revised (51)
  5. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 340 to confirmed 135
    • Study sites revised (51)
    v37
Show 34 earlier versionsHide 34 earlier versions
  1. Enrollment target: 244 to 340
    • Study sites: 49 to 51
    • Eligibility criteria expanded, about 181 words
    v35
  2. Study sites revised (49)v34
  3. Study sites: 47 to 49v33
  4. Study sites: 46 to 47v32
  5. Study sites revised (46)v31
  6. Study sites: 45 to 46v30
  7. Study sites: 44 to 45v29
  8. Study sites: 43 to 44v28
  9. Study sites: 42 to 43v27
  10. Study sites revised (42)v26
  11. Study sites: 40 to 42v25
  12. Enrollment target: 128 to 244v24 Show 4 more changesShow less
    • Primary and study completion dates pushed to Mar 2031
    • Study sites: 38 to 40
    • Eligibility criteria expanded, about 29 words
    • Secondary endpoints revised (5)
  13. Study sites: 37 to 38v23
  14. Study sites: 35 to 37
    • Primary completion date: Jun 7, 2027 to Jun 2027
    • Study completion date: Apr 11, 2029 to Apr 2029
    v22
  15. Study sites: 34 to 35v21
  16. Study sites: 33 to 34v20
  17. Study sites: 32 to 33v19
  18. Study sites: 31 to 32v18
  19. Study sites: 30 to 31v17
  20. Study sites: 28 to 30v16
  21. Study sites: 25 to 28v15
  22. Study sites: 24 to 25v14
  23. Study sites: 23 to 24v13
  24. Study sites: 22 to 23v12
  25. Study sites: 20 to 22v11
  26. Study sites: 19 to 20v10
  27. Study sites: 18 to 19v9
  28. Study sites: 17 to 18
    • Study completion date: Jun 7, 2027 to Apr 11, 2029
    v8
  29. Study sites: 15 to 17v7
  30. Study sites: 14 to 15v6
  31. Enrollment target: 188 to 128
    • Study sites: 13 to 14
    • Secondary endpoints: details revised at 1 of 5 entries
    v5
  32. Study sites: 11 to 13v4
  33. Enrollment target: 128 to 188v3
  34. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 8 to 11
    • Start date changed from estimate of Jun 2, 2023 to Jun 9, 2023
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Number of Participants with Adverse Events (AE)
Timeframe: Up to Approximately 88 Months
Change in Laboratory Parameters
Timeframe: Up to Approximately 88 Months
Change in Vital Signs
Timeframe: Up to Approximately 88 Months
Change in Electrocardiogram (ECG)
Timeframe: Up to Approximately 88 Months

Secondary (5)

Maximum Observed Serum Concentration (Cmax) of ABBV-101
Time to Cmax (Tmax) of ABBV-101
Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-101
Number of Participants with Response of Partial Response (PR) or Better Response (Overall Response) per Disease-Specific Criteria
Duration of Response (DOR)

Arms and interventions

Dose Escalation: ABBV-101Experimental

Participants with relapsed or refractory (R/R) Non-Hodgkin's lymphoma (NHL) will receive escalating doses of ABBV-101, until the maximum administered dose (MAD)/Maximum tolerated dose (MTD) is determined, as part of the approximately 88 month study duration.

Drugs: ABBV-101

Sites

51 sites in 9 countries

United States 14, France 6, Germany 6, Spain 6, Italy 5, Israel 4, Japan 4, United Kingdom 4, Canada 2