Tafasitamab and Lenalidomide Followed by Tafasitamab and ICE as Salvage Therapy for Transplant Eligible Patients With Relapsed/ Refractory Large B-Cell Lymphoma

Part of paid clinical trials in Columbus, Ohio.

Sponsor
David Bond, MD
Study ID
NCT05821088
Phase
PHASE2
Status
Recruiting
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Conditions

  • Recurrent B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma
  • Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
  • Recurrent Grade 3b Follicular Lymphoma
  • Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
  • Recurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
  • Recurrent High Grade B-Cell Lymphoma, Not Otherwise Specified
  • Recurrent Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type
  • Recurrent Primary Mediastinal (Thymic) Large B-Cell Lymphoma
  • Recurrent T-Cell/Histiocyte-Rich Large B-Cell Lymphoma
  • Recurrent Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma
  • Recurrent Transformed Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma
  • Refractory B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma
  • Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
  • Refractory Grade 3b Follicular Lymphoma
  • Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
  • Refractory High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
  • Refractory High Grade B-Cell Lymphoma, Not Otherwise Specified
  • Refractory Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type
  • Refractory Primary Mediastinal (Thymic) Large B-Cell Lymphoma
  • Refractory T-Cell/Histiocyte-Rich Large B-Cell Lymphoma
  • Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma
  • Refractory Transformed Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma

Eligibility Criteria

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

Interventions

  • Biopsy — PROCEDURE
    Undergo tissue biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Carboplatin — DRUG
    Given IV
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Etoposide — DRUG
    Given IV
  • Ifosfamide — DRUG
    Given IV
  • Lenalidomide — DRUG
    Given PO
  • Positron Emission Tomography — PROCEDURE
    Undergo PET
  • Tafasitamab — BIOLOGICAL
    Given IV

Study Details

This phase II clinical trial evaluates tafasitamab and lenalidomide followed by tafasitamab and the carboplatin, etoposide and ifosfamide (ICE) regimen as salvage therapy for transplant eligible patients with large B-cell lymphoma that has come back (relapsed) or has not responded to treatment (refractory). Tafasitamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Lenalidomide may have antineoplastic activity which may help block the formation of growths that may become cancer. Drugs used in chemotherapy, such as carboplatin, etoposide and ifosfamide work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving tafasitamab and lenalidomide followed by ICE may be a better treatment for patients with relapsed or refractory large B-cell lymphomas.

Key Dates

Start date
Jun 29, 2023
Status verified
Nov 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: Treatment (tafasitamab, lenalidomide, ICE regimen)
    Patients receive tafasitamab IV, lenalidomide PO, etoposide IV, ifosfamide IV and carboplatin IV on study. Patients undergo PET or CT, and undergo blood sample collection throughout the study. Patients may undergo tissue biopsy on study.

Primary Outcome Measure

Complete remission (CR) rate [ Time Frame: At the end of Cycle (each cycle is 28 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
David A. Bond, MD
[email protected]
614-293-3196
David A. Bond, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Ohio State University Comprehensive Cancer Center· Columbus, OH

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