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Acalabrutinib in Combination With R-CHOP for Previously Untreated Diffuse Large B-cell Lymphoma (DLBCL)

Study acronym: REMoDL-A
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv7
  2. Primary completion date: Jan 2027 to Nov 2027 Trial status: Recruiting to Active, Not Recruiting · Completion date: Jul 2027 to May 2028 · Site details revised at 33 of 33 sitesv6 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Completion date: Jul 2027 to May 2028
    • Site details revised at 33 of 33 sites
  3. Primary completion date: Oct 2025 to Jan 2027 Completion date: Mar 2026 to Jul 2027v5 Show 1 more changeShow less
    • Completion date: Mar 2026 to Jul 2027
  4. Study sites: 3 to 33 Eligibility criteria expanded, about 1 wordv4 Show 1 more changeShow less
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  5. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jun 2021 to Oct 19, 2021 · Study sites: 0 to 3 · Completion date: Oct 2025 to Mar 2026v3 Show 3 more changesShow less
    • Start date changed from estimate of Jun 2021 to Oct 19, 2021
    • Study sites: 0 to 3
    • Completion date: Oct 2025 to Mar 2026
  6. Primary and study completion dates: May 2024 to Oct 2025 Start date: Nov 2020 to Jun 2021 · Secondary endpoints revised (10) · Study description revised · 1 morev2 Show 4 more changesShow less
    • Start date: Nov 2020 to Jun 2021
    • Secondary endpoints revised (10)
    • Study description revised
    • Eligibility criteria shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
This study evaluates the addition of Acalabrutinib to current standard therapy of Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisolone (R-CHOP) for patients with previously untreated CD20 positive Diffuse Large B-cell Lymphoma (DLBCL) requiring full course chemoimmunotherapy. All patients will receive one cycle of R-CHOP. Two thirds of patients (Arm B) will go on to receive a further 5 cycles (every 21 days) of R-CHOP with Acalabrutinib. Acalabrutinib will be taken orally twice daily continuously in 21 day cycles. One third of patients (Arm A) will continue with 5 cycles of R-CHOP. Patients will be followed up initially for 24 months and then for disease status and survival until 114 progression events have been observed.
Trial Details
NCT Number NCT04546620
Lead Sponsor University Hospital Southampton NHS Foundation Trust
Collaborators: AstraZeneca
Conditions Diffuse Large B Cell Lymphoma
Enrollment 453 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov