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NCT03534323

Duvelisib and Venetoclax in Relapsed or Refractory CLL or SLL or RS

StatusCompleted
PhasePhase 1/2
Primary completion
Track this trial

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Record History

All 17 versions: 15 with changes below, 2 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Trial completed
    • Eligibility criteria expanded, about 35 words
    • Publications: details revised at 1 of 1 entry
  2. Results first posted: Mar 23, 2026
    • Enrollment target: 35 to 55
    • Study arms: 1 to 4
    v16
  3. Primary endpoints revised (2)
    • Enrollment target: estimated 67 to confirmed 35
    • Secondary endpoints: 7 to 3
    v15
  4. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Jul 1, 2024 to Dec 1, 2024
    • Site details revised at 7 of 7 sites
    v12
  5. Site details revised at 1 of 7 sitesv11
Show 9 earlier versionsHide 9 earlier versions
  1. Primary completion date: Jul 1, 2023 to Jul 1, 2024
    • Study completion date: Jul 1, 2025 to Jul 1, 2026
    • Site details revised at 3 of 7 sites
    v10
  2. Site details revised at 2 of 7 sitesv9
  3. Primary completion date: Jun 1, 2022 to Jul 1, 2023
    • Study completion date: Jun 1, 2024 to Jul 1, 2025
    • Site contacts updated at 1 of 7 sites
    v8
  4. Site contacts updated at 1 of 7 sitesv7
  5. Collaborator revisedv6
  6. Study sites: 9 to 7v5
  7. Enrollment target: 47 to 67v4 Show 4 more changesShow less
    • Study sites: 3 to 9
    • Eligibility criteria expanded, about 70 words
    • Study description expanded, about 29 words
    • Study title expanded, about 2 words
  8. Site details revised at 3 of 3 sitesv3
  9. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 1, 2018 to Jul 12, 2018
    • Site details revised at 3 of 3 sites
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Complete Response Rate (CRR)
Timeframe: Response assessment on the end of cycle 3, 6 and 13. With 28 days per cycle.
Overall Response Rate (ORR)
Timeframe: Response assessment on the end of cycle 3, 6 and 13. With 28 days per cycle.

Secondary (3)

12-month Progression-Free Survival (PFS) Rate
1-year Overall Survival (OS)
1-year MRD Negativity Rate

Arms and interventions

Phase 1 Level 1: 100 mg Venetoclax (daily) + 25 mg Duvelisib (BID)Experimental

Duvelisib will be given alone for the first seven days. On day 8 Venetoclax will be added. * Duvelisib will be administered orally twice daily of 25mg * Venetoclax will be administered orally daily of 100mg * All patients will be admitted for administration of the initial dose of venetoclax at each dose escalation

Phase 1 Level 2: 200 mg Venetoclax (daily) + 25 mg Duvelisib (BID)Experimental

* Duvelisib will be administered orally twice daily of 25mg * Venetoclax will be administered orally daily of 200mg * All patients will be admitted for administration of the initial dose of venetoclax at each dose escalation

Phase 1 Level 3: 400 mg Venetoclax (daily) + 25 mg Duvelisib (BID)Experimental

* Duvelisib will be administered orally twice daily of 25mg * Venetoclax will be administered orally daily of 400mg * All patients will be admitted for administration of the initial dose of venetoclax at each dose escalation

Phase 2: 400 mg Venetoclax (daily) + 25 mg Duvelisib (BID)Experimental

* Duvelisib will be administered orally twice daily of 25mg * Venetoclax will be administered orally daily of 400mg

Drugs: Duvelisib, Venetoclax

Sites

7 sites in 1 country