Polatuzumab Vedotin, Venetoclax, and Rituximab and Hyaluronidase Human for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma

Part of paid clinical trials in Sioux City, Iowa.

Sponsor
Academic and Community Cancer Research United
Study ID
NCT04659044
Phase
PHASE2
Status
Terminated

Conditions

  • Recurrent B-Cell Non-Hodgkin Lymphoma
  • Recurrent Grade 1 Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Recurrent Grade 3a Follicular Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Recurrent Small Lymphocytic Lymphoma
  • Refractory B-Cell Non-Hodgkin Lymphoma
  • Refractory Grade 1 Follicular Lymphoma
  • Refractory Grade 2 Follicular Lymphoma
  • Refractory Grade 3a Follicular Lymphoma
  • Refractory Mantle Cell Lymphoma
  • Refractory Marginal Zone Lymphoma
  • Refractory Small Lymphocytic Lymphoma

Eligibility Criteria

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

Interventions

Study Details

This phase II trial studies the effect of polatuzumab vedotin, venetoclax, and rituximab and hyaluronidase human in treating patients with mantle cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Polatuzumab vedotin is a monoclonal antibody, polatuzumab, linked to a toxic agent called vedotin. Polatuzumab attaches to CD79B positive cancer cells in a targeted way and delivers vedotin to kill them. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cell growth. Rituximab hyaluronidase is a combination of rituximab and hyaluronidase. Rituximab binds to a molecule called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Hyaluronidase allows rituximab to be given by injection under the skin. Giving rituximab and hyaluronidase by injection under the skin is faster than giving rituximab alone by infusion into the blood. Giving polatuzumab vedotin, venetoclax, and rituximab and hyaluronidase human may work better than standard therapy in treating patients with mantle cell lymphoma.

Key Dates

Start date
Apr 1, 2021
Status verified
Aug 2024
Primary completion
Mar 28, 2024
Completion
Mar 29, 2024

Study Design

Enrollment
3 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (rituximab, polatuzumab vedotin, venetoclax)
    INDUCTION: Patients receive rituximab IV on day 1 of cycle 1 and rituximab and hyaluronidase human SC over 5 minutes on day 1 of cycles 2-6. Patients also receive polatuzumab vedotin IV over 30-90 minutes on day 1 and venetoclax PO daily on days 1-21. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive venetoclax PO daily on days 1-21 and rituximab and hyaluronidase human SC over 5 minutes every 60 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Number of Patients Experiencing a Complete Response (CR) [ Time Frame: 3 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
Siouxland Regional Cancer CenterSioux CityIowa51101-
Michigan Cancer Research Consortium NCORPAnn ArborMichigan48106-
Washington University School of MedicineSt LouisMissouri63110-
Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew YorkNew York10016-
University of Pennsylvania/Abramson Cancer CenterPhiladelphiaPennsylvania19104-

Find similar trials in Sioux City, IA

By research site
Siouxland Regional Cancer Center· Sioux City, IAMichigan Cancer Research Consortium NCORP· Ann Arbor, MIWashington University School of Medicine· St Louis, MOLaura and Isaac Perlmutter Cancer Center at NYU Langone· New York, NYUniversity of Pennsylvania/Abramson Cancer Center· Philadelphia, PA

Related Studies