Duvelisib Following Chimeric Antigen Receptor T-Cell Therapy

StatusActive, Not Recruiting
PhasePhase 1
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Interventions modified
    • Trial arms changed: 3 → 4
    • Eligibility criteria expanded, about 24 words
    • Collaborators: 3 to 2
  2. Primary completion date changed from estimate of Jan 9, 2026 to Jan 6, 2026v14
  3. Primary completion date: Dec 31, 2025 to Jan 9, 2026
    • Study completion date: May 31, 2030 to May 22, 2030
    v13
  4. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 43 to confirmed 42
    • Site details revised
    v12
  5. 2 versions Re-verified since Nov 1, 2024, no change to tracked fieldsv10-v11
Show 8 earlier versionsHide 8 earlier versions
  1. Primary completion date: May 31, 2025 to Dec 31, 2025
    • Study completion date: Oct 31, 2029 to May 31, 2030
    v9
  2. Eligibility criteria shortened, about 27 words
    • Secondary endpoints: 12 to 14
    v8
  3. Study completion date: May 31, 2025 to Oct 31, 2029
    • Secondary endpoints: details revised at 2 of 12 entries
    v7
  4. Collaborators: 2 to 3v6
  5. Collaborators: 1 to 2v5
  6. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Jun 30, 2025 to May 31, 2025
    • Start date changed from estimate of Mar 31, 2022 to Feb 28, 2022
    • Site details revised
    v4
  7. Re-verified, no change to tracked fieldsv3
  8. Start date: Nov 30, 2021 to Mar 31, 2022
    • Primary and study completion dates: Feb 26, 2025 to Jun 30, 2025
    • Eligibility criteria expanded, about 108 words
    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.
While chimeric antigen receptor T-cell (CAR T-cell) therapy produces impressive response rates in heavily pre-treated patients, early loss of response remains a barrier. One potential mechanism of relapse is limited CAR T-cell persistence. Pre-clinical research shows that PI3K inhibition represents an intriguing mechanism for increasing CAR T-cell persistence that is easily reversible and CAR T-cell agnostic. The investigators hypothesize that PI3K inhibition with duvelisib would be safe, may provide effective prophylaxis against cytokine release syndrome (CRS), and may enhance the persistence and efficacy of CAR T-cells in the treatment of hematologic malignancies.
Trial Details
NCT Number NCT05044039
Lead Sponsor Washington University School of Medicine
Collaborators: SecuraBio, The Foundation for Barnes-Jewish Hospital
Conditions
(from sponsor)		 Non-Hodgkin Lymphoma, Acute Lymphocytic Leukemia
Related terms Lymphoma, Non-Hodgkin, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Enrollment 42 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov