Phase 2 Open Label Randomized Study of Pirtobrutinib and Brexucabtagene Autoleucel in R/R MCL

Part of paid clinical trials in Stanford, California.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT06553872
Phase
PHASE2
Status
Recruiting
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Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pirtobrutinib — DRUG
    Pirtobrutinib is a non-covalent BTKi that has preserved activity in the presence of mutations that drive BTKi resistance.
  • Brexucabtagene Autoleucel — DRUG
    Brexucabtagene autoleucel is an autologous CD19-directed chimeric antigen receptor (CAR) T-cell therapy (brexu-cel).

Study Details

This is a phase 2, open-label, randomized, multicenter clinical trial in patients with relapsed/refractory mantle cell lymphoma (R/R MCL) who meet the criteria for standard-of-care FDA label for CD19 CAR T-cell therapy with brexucabtagene autoleucel (brexu-cel).

Key Dates

Start date
Aug 23, 2024
Status verified
Mar 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Participants will recieve pirtobrutinib as bridging therapy from day -27 to day -7. Participants randomized to Arm A (n=30) will continue to receive concurrent pirtobrutinib ("con-pirto"), starting at day -6 and continued until 1-year post-CD19 CAR T-cell therapy with brexucel.
  • Experimental: Arm B
    Participants will recieve pirtobrutinib as bridging therapy from day -27 to day -7. Participants on Arm B (n=30) will discontinue pirtobrutinib after day -7 and will not receive concurrent pirtobrutinib ("con-none") between day -6 and 1-year post-CD19 CAR T-cell therapy.

Primary Outcome Measure

Progression-free survival (PFS) - Historical comparison [ Time Frame: 12 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Stanford Cancer CenterStanfordCalifornia94305
Saurabh Dahiya, MD
650-724-4155
Saurabh Dahiya, MD (SUB_INVESTIGATOR)
Univ of Miami - Sylvester Comprehensive Cancer CenterMiamiFlorida33136
Jay Spiegel, MD
305-243-5302
Jay Spiegel, MD (SUB_INVESTIGATOR)
Moffitt Cancer CenterTampaFlorida33612
Ruthie Chae
[email protected]
813-745-3425
Michael Jain, MD, PhD (PRINCIPAL_INVESTIGATOR)
Julio Chavez, MD (SUB_INVESTIGATOR)
Sameh Gaballa, MD (SUB_INVESTIGATOR)
Farhad Khimani, MD (SUB_INVESTIGATOR)
Aleksandr Lazaryan, MD, PhD (SUB_INVESTIGATOR)
Frederick Locke, MD (SUB_INVESTIGATOR)
Sayeef Mirza, MD (SUB_INVESTIGATOR)
Taiga Nishihori, MD (SUB_INVESTIGATOR)
Bijal Shah, MD (SUB_INVESTIGATOR)

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By research site
Stanford Cancer Center· Stanford, CAUniv of Miami - Sylvester Comprehensive Cancer Center· Miami, FLMoffitt Cancer Center· Tampa, FL

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