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NCT03961672

Intermittent Duvelisib Dosing in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

StatusActive, Not Recruiting
PhasePhase 2
Primary completion
Track this trial

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Record History

All 17 versions: 16 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Study completion pushed from Oct 26, 2026 to Oct 25, 2027 Show 5 more changesShow less
    • Start date: May 13, 2020 to May 16, 2020
    • Eligibility criteria expanded, about 52 words
    • Secondary endpoints: details revised at 4 of 5 entries
    • Study description revised
    • Publications: details revised at 1 of 1 entry
  2. Study completion date: Nov 5, 2025 to Oct 26, 2026v16
  3. Study completion date: Jun 15, 2025 to Nov 5, 2025v15
  4. Study completion date: Dec 15, 2024 to Jun 15, 2025v14
  5. Results first posted: Aug 7, 2024
    • Study completion date: Nov 13, 2024 to Dec 15, 2024
    • Secondary endpoints revised (5)
    v13
Show 10 earlier versionsHide 10 earlier versions
  1. Primary endpoint revised
    • Primary completion date changed from estimate of Jun 27, 2024 to Jul 31, 2023
    • Study completion date: Jun 27, 2024 to Nov 13, 2024
    • Secondary endpoints revised (5)
    v12
  2. Primary and study completion dates: Dec 27, 2023 to Jun 27, 2024v11
  3. Primary and study completion dates: Apr 27, 2023 to Dec 27, 2023v10
  4. Trial status: Suspended to Active, Not Recruiting
    • Enrollment target: estimated 30 to confirmed 15
    v9
  5. Trial status: Recruiting to Suspended Sponsor's reason: Staff transitions
    • Site details revised at 3 of 3 sites
    v8
  6. Primary completion date: Apr 29, 2022 to Apr 27, 2023
    • Study completion date: Dec 27, 2024 to Apr 27, 2023
    v6
  7. Site contacts updated at 1 of 3 sitesv5
  8. Lead sponsor: OHSU Knight Cancer Institute to City of Hope Medical Centerv4 Show 6 more changesShow less
    • Trial status: Active, Not Recruiting to Recruiting
    • Enrollment target: 4 to 30
    • Start date: May 13, 2019 to May 13, 2020
    • Study sites: 2 to 3
    • Secondary endpoints: details revised at 1 of 5 entries
    • Eligibility criteria shortened, about 4 words
  9. Trial status: Recruiting to Active, Not Recruitingv3 Show 5 more changesShow less
    • Enrollment target: estimated 30 to confirmed 4
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints revised (5)
    • Study description revised
    • Site details revised at 2 of 2 sites
  10. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 1, 2019 to May 13, 2019
    • Site details revised at 2 of 2 sites
    v2
  1. Study First Submitted
  • Stopped: terminated, suspended or withdrawn
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Progression Free Survival (PFS) at 12 Months
Timeframe: First dose of duvelisib until death, time of progression, start of new therapy, or 12 months from start of therapy, whichever occurs first

Secondary (5)

Objective Response Rate (ORR) (Including Complete Response [CR] and Partial Response [PR])
Median Progression-Free Survival (PFS)
Percentage of the Participants With 12-month Duration of Response (DOR)
Percentage of Participants With Grade 3 4 5 Toxicity Related to Duvelisib
Number of Administrated Cycles of the Study Treatment

Arms and interventions

Treatment (duvelisib)Experimental

INDUCTION: Patients receive duvelisib PO BID on days 1-28. Cycles repeat every 28 days for 12 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive duvelisib PO BID on days 1-2, 8-9, 15-16, and 22-23. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drugs: Duvelisib

Sites

3 sites in 1 country