Zanubrutinib and Lisocabtagene Maraleucel for the Treatment of Richter's Syndrome

Part of paid clinical trials in New York, New York.

Sponsor
Aseel Alsouqi
Study ID
NCT05873712
Phase
PHASE2
Status
Recruiting
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Conditions

  • Recurrent Transformed B-Cell Non-Hodgkin Lymphoma
  • Recurrent Transformed Chronic Lymphocytic Leukemia
  • Recurrent Transformed Non-Hodgkin Lymphoma
  • Refractory Transformed
  • Refractory Transformed B-cell Non-Hodgkin Lymphoma
  • Refractory Transformed Chronic Lymphocytic Leukemia
  • Refractory Transformed Non-Hodgkin Lymphoma
  • Transformed Chronic Lymphocytic Leukemia to Diffuse Large B-Cell Lymphoma

Eligibility Criteria

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

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Bone Marrow Biopsy — PROCEDURE
    Undergo BM biopsy
  • Computed Tomography — PROCEDURE
    Undergo CT and/or PET/CT
  • Cyclophosphamide — DRUG
    Given IV
  • Fludarabine — DRUG
    Given IV
  • Leukapheresis — PROCEDURE
    Given IV
  • Lisocabtagene Maraleucel — BIOLOGICAL
    Given IV
  • Lymph Node Biopsy — PROCEDURE
    Undergo lymph node biopsy
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT
  • Zanubrutinib — DRUG
    Given PO

Study Details

This phase II trial tests how well zanubrutinib and lisocabtagene maraleucel (liso-cel) work together in treating patients with Richter's syndrome that has come back (recurrent) or does not respond to treatment (refractory). Richter's syndrome occurs when chronic lymphocytic leukemia and/or small lymphocytic leukemia transforms into an aggressive lymphoma, which is a cancer of the lymph nodes. Zanubrutinib is a class of medication called a kinase inhibitor. These drugs work by preventing the action of abnormal proteins that tell cancer cells to multiply, which helps stop the spread of cancer. Liso-cel is a type of treatment known as chimeric antigen receptor (CAR) T cell therapy. CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving zanubrutinib and liso-cell together may kill more cancer cells in patients with recurrent or refractory Richter's syndrome.

Key Dates

Start date
Jul 28, 2023
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: Treatment (zanubrutinib, liso-cel)
    Patients receive zanubrutinib PO BID for up to day 90 and undergo leukaphereis at least 14 days after starting zanubrutinib. Patients receive fludarabine IV and cyclophosphamide IV on days -5 to -3 and liso-cel IV over 5-30 minutes on day 0. Patients also undergo BM biopsy and lymph node biopsy at screening and follow up, and undergo collection of blood samples and CT, PET/CT, and/or MRI throughout the trial.

Primary Outcome Measure

Overall response rate [ Time Frame: At 90 days after lisocabtagene maraleucel (liso-cel) infusion ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Patricia Worker
[email protected]
(212) 824-7337
Adam Kittai, MD (PRINCIPAL_INVESTIGATOR)
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Jennifer A Woyach, MD
[email protected]
614-293-8165
Jennifer A Woyach, MD (PRINCIPAL_INVESTIGATOR)
Huntsman Cancer InstituteSalt Lake CityUtah84112
Lindsey Gilstrap
[email protected]
801-213-5652
Rachel Kingsford
[email protected]
801-585-0115
Harsh Shah, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Icahn School of Medicine at Mount Sinai· New York, NYOhio State University Comprehensive Cancer Center· Columbus, OHHuntsman Cancer Institute· Salt Lake City, UT

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