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NCT06263491

Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients

StatusRecruiting
PhasePhase 2
Primary completion (estimated)

At risk: Primary completion moved 2 years later.

See at-risk trials from M.D. Anderson Cancer Center

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Record History

All 17 versions: 7 with changes below, 10 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates pushed to Nov 1, 2028
    • Eligibility criteria expanded, about 32 words
    • Study description expanded, about 4 words
  2. Site contact updatedv16
  3. Primary completion date: Mar 1, 2025 to Nov 1, 2026v10
  4. Trial status: Suspended to Recruiting
    • Site details revised
    v5
  5. Trial status: Not Yet Recruiting to Suspended Sponsor's reason: PI Request
    • Start date: Aug 31, 2024 to May 29, 2024
    • Site contact updated
    v4
  6. Site contact updatedv2
  7. Study First Submitted
  • Stopped: terminated, suspended or withdrawn
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Safety and adverse events (AEs)
Timeframe: Through study completion; an average of 1 year

Arms and interventions

Cohort AExperimental

If participants show that they have no MRD, participants will be in Cohort A and will stop taking pirtobrutinib. Participants will continue to be observed and tested for MRD, and participants will be able to continue receiving the drug if you test positive.

Cohort BExperimental

If participants test positive for MRD at the 24 month time point, participants will be in Cohort B and the participant will continue taking pirtobrutinib.

Drugs: Rituximab, Pirtobrutinib

Sites

1 site in 1 country

  • MD Anderson Cancer CenterHouston, Texas, United States