Epcoritamab Plus Standard of Care Platinum-Based Chemotherapy and Autologous Hematopoietic Cell Transplant for the Treatment of Relapsed or Refractory Large B-cell Lymphoma

Part of paid clinical trials in Sacramento, California.

Sponsor
Joseph Tuscano
Study ID
NCT06905509
Phase
PHASE2
Status
Recruiting
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Conditions

  • Recurrent Diffuse Large B-Cell Lymphoma
  • Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
  • Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements
  • Recurrent High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements
  • Recurrent High Grade B-Cell Lymphoma, Not Otherwise Specified
  • Recurrent Nodal Marginal Zone Lymphoma
  • Recurrent Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma
  • Refractory Diffuse Large B-Cell Lymphoma
  • Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
  • Refractory High Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements
  • Refractory High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements
  • Refractory High Grade B-Cell Lymphoma, Not Otherwise Specified
  • Refractory Nodal Marginal Zone Lymphoma
  • Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma

Eligibility Criteria

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

Interventions

  • Autologous Hematopoietic Stem Cell Transplantation — PROCEDURE
    Undergo autoHCT
  • Carboplatin — DRUG
    Given carboplatin
  • Cytarabine — DRUG
    Given cytarabine
  • Dexamethasone — DRUG
    Given dexamethasone
  • Epcoritamab — BIOLOGICAL
    Given SC
  • Etoposide Phosphate — DRUG
    Given etoposide phosphate
  • Gemcitabine — DRUG
    Given gemcitabine
  • Ifosfamide — DRUG
    Given ifosfamide
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA
  • Oxaliplatin — DRUG
    Given oxaliplatin
  • Rituximab — BIOLOGICAL
    Given rituximab

Study Details

This phase II trial tests how well epcoritamab in combination with standard of care (SOC) platinum-based chemotherapy (rituximab, ifosfamide, carboplatin, etoposide \[RICE\], rituximab, cytarabine, dexamethasone, oxaliplatin or carboplatin RDHAP/X\] or gemcitabine and oxaliplatin \[Gem/Ox\]) and autologous hematopoietic cell transplant (HCT) works in treating patients with large B-cell lymphoma (LBCL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Epcoritamab, a type of bispecific T-cell engager, binds to a protein called CD3, which is found on T cells (a type of white blood cell). It also binds to a protein called CD20, which is found on B cells (another type of white blood cell) and some lymphoma cells. This may help the immune system kill cancer cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells and some types of cancer cells. This may help the immune system kill cancer cells. Chemotherapy drugs, such as ifosfamide, etoposide phosphate, cytarabine, and gemcitabine, 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. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. An autologous HCT is a procedure in which blood-forming stem cells (cells from which all blood cells develop) are removed, stored, and later given back to the same person. Giving epcoritamab in combination with SOC platinum-based chemotherapy, such as RICE, RDHAP/X and Gem/Ox, and autologous HCT may kill more cancer cells in patients with relapsed or refractory LBCL.

Key Dates

Start date
Jul 31, 2025
Status verified
Sep 2025
Primary completion
Jul 1, 2028
Completion
Aug 1, 2030

Study Design

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

Arms

  • Experimental: Treatment (epcoritamab, SOC chemotherapy, autoHCT)
    See Detailed Description

Primary Outcome Measure

Complete response rate (CRR) [ Time Frame: From first dose up to 2 years post-autologous hematopoietic cell transplantation (autoHCT) therapy ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817
Selina Laqui
[email protected]
916-734-0565
Joseph M. Tuscano (PRINCIPAL_INVESTIGATOR)

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By research site
University of California Davis Comprehensive Cancer Center· Sacramento, CA

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