Tafasitamab and Lenalidomide as First Salvage Therapy for Residual Large B Cell Lym

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT06760156
Phase
PHASE2
Status
Recruiting

Conditions

  • Large B-cell Lymphoma

Eligibility Criteria

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

Interventions

  • Tafasitamab — DRUG
    The recommended dose of tafasitamab is 12 mg/kg.
  • Lenalidomide — DRUG
    The starting dose for lenalidomide will be 25 mg PO daily.

Study Details

The purpose of the study is to evaluate the safety and efficacy of tafasitamab and lenalidomide in participants with Large B Cell Lymphoma (LBCL) after axicabtagene ciloleucel (axi-cel) treatment. Participants will be asked to spend about 12 months in this study.

Key Dates

Start date
Mar 19, 2025
Status verified
Mar 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tafasitamab and Lenalidomide Treatment
    Participants will receive the study drug, Tafasitamab, intravenously on a weekly basis for the first three 28-day cycles (Cycles 1-3) and then every 2 weeks starting at Cycle 4 onwards. Participants will take the study drug, Lenalidomide, once daily for 21 days out of each 28-day cycle for 6 cycles.

Primary Outcome Measure

Complete Response Rate (CRR) [ Time Frame: Up to 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Frederick Locke, MD (PRINCIPAL_INVESTIGATOR)
Julio Chavez, MD (SUB_INVESTIGATOR)
Sameh Gaballa, MD (SUB_INVESTIGATOR)
Michael Jain, MD, PhD (SUB_INVESTIGATOR)
Farhad Khimani, MD (SUB_INVESTIGATOR)
Aleksandr Lazaryan, MD, PhD (SUB_INVESTIGATOR)
Sayeef Mirza, MD (SUB_INVESTIGATOR)
Taiga Nishihori, MD (SUB_INVESTIGATOR)
Bijal Shah, MD (SUB_INVESTIGATOR)

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