Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04446962 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

LOC-R01 Study of Lenalidomide and Ibrutinib in Association With Rituximab-Methotrexate Procarbazine Vincristin (R-MPV)

Study acronym: LOC-R01
StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Aug 30, 2025 to Feb 2, 2035
    • Study sites revised (28)
    • Publications: details revised at 1 of 1 entry
    v13
  2. Primary completion date: Feb 28, 2025 to Aug 30, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 29 to 28
    • Study completion date: Feb 28, 2035 to Aug 30, 2035
    v12
  3. Primary completion date: Jan 15, 2024 to Feb 28, 2025
    • Study completion date: Jan 15, 2031 to Feb 28, 2035
    • Site details revised at 1 of 29 sites
    v11
  4. Re-verified, no change to tracked fieldsv10
  5. Enrollment target: 128 to 118
    • Study sites: 27 to 29
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 25 to 27v8
  2. Site details revised at 2 of 25 sitesv7
  3. Eligibility criteria expanded, about 16 words
    • Site details revised at 6 of 25 sites
    v6
  4. Start date: Aug 28, 2020 to Oct 30, 2020
    • Site details revised at 6 of 25 sites
    v5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 15, 2020 to Aug 28, 2020
    • Site details revised at 25 of 25 sites
    v4
  6. Start date: Jul 15, 2020 to Sep 15, 2020v3
  7. Study title expanded, about 4 wordsv2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Institut Curie
43 trials monitored
See 1 trial at risk
Non-Hodgkin Lymphoma
2,013 trials monitored
See 115 trials at risk
DLBCL
703 trials monitored
See 44 trials at risk
This study is to improve the first-line induction chemotherapy, by combining either Ibrutinib, or Lenalidomide, to a conventional immuno- chemotherapy of R-MPV type (Rituximab-Methotrexate-Procarbazine-Vincristine). This is a randomized Phase II trial, preceded by a dose escalation phase Ib. The objective of the phase Ib is to rule out any limiting toxicity of the new treatment associations, and to determine the recommended dose of Lenalidomide and Ibrutinib to be used in the phase II. In the phase II study, patients will receive 4 cycles of R-MPV + Lenalidomide or 4 cycles of R-MPV + Ibrutinib. The therapeutic response will be evaluated after the 2nd and the 4th cycle. Patients in good therapeutic response will proceed to the consolidation phase with Autologous Stem Cell Transplantation (ASCT).
Trial Details
NCT Number NCT04446962
Lead Sponsor Institut Curie
Collaborators: National Cancer Institute, France
Conditions
(from sponsor)		 Lymphoma, Large B-Cell, Diffuse, Central Nervous System Neoplasms, Primary
Related terms Central Nervous System Neoplasms, Lymphoma, Lymphoma, Large B-Cell, Diffuse, Neurologic Manifestations
Enrollment 118 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov