Glofit and Obin in Follicular Lymphoma and Marginal Zone Lymphoma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Reid Merryman, MD
Study ID
NCT05783596
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Obinutuzumab — DRUG
    Humanized glycoengineered type II anti-CD20 monoclonal antibody, via IV infusion.
  • Glofitamab — DRUG
    T-cell bispecific humanized monoclonal antibody, via IV infusion.

Study Details

The purpose of this study is to determine how effective and safe the combination of glofitamab and obinutuzumab is in treating patients with Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL) who have not received other treatments for their lymphoma. The names of the study drugs involved in this study are: * Glofitamab (a type of immunotherapy) * Obinutuzumab (a type of immunotherapy)

Key Dates

Start date
Jul 18, 2023
Status verified
Mar 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2029

Study Design

Enrollment
47 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Obinutuzumab + Glofitamab for Follicular Lymphoma
    Participants will undergo study procedures as outlined: * Imaging scans (CT or PET) at screening and after cycles 3, 7, and 12 of treatment. * Bone marrow biopsy at baseline. * Cycle 1 * Days -21, -14, -7, 0 of 36 day cycle: Predetermined dose of Obinutuzumab. * Days 1 and 8 of 36 day cycle: Predetermined dose of Glofitamab. (First dose will be administered in the hospital.) * Cycles 2 - 12: o Day 1 of 21 day cycle: Predetermined dose of Glofitamab. * Bone marrow biopsy within 2 weeks of end of treatment. * Imaging scans (CT or PET) at 12, 18, and 24 months after treatment initiation. * Follow up visits up to 5 years after treatment completion.
  • Experimental: Obinutuzumab + Glofitamab for Marginal Zone Lymphoma
    Participants will undergo study procedures as outlined: * Imaging scans (CT or PET) at screening and after cycles 3, 7, and 12 of treatment. * Bone marrow biopsy at baseline. * Cycle 1 * Days -21, -14, -7, 0 of 36 day cycle: Predetermined dose of Obinutuzumab. * Days 1 and 8 of 36 day cycle: Predetermined dose of Glofitamab. (First dose will be administered in the hospital.) * Cycles 2 - 12: o Day 1 of 21 day cycle: Predetermined dose of Glofitamab. * Bone marrow biopsy within 2 weeks of end of treatment. * Imaging scans (CT or PET) at 12, 18, and 24 months after treatment initiation. * Follow up visits up to 5 years after treatment completion.

Primary Outcome Measure

End of Treatment (EOT) Complete Metabolic Response (CMR) Rate [ Time Frame: (Cycle 1 = 36 days, cycle 2 - 12 = 21 days), up to 267 days ]

Locations (4)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Columbia University Irving Medical CenterNew YorkNew York10032-
Mount Sinai Medical CenterNew YorkNew York10128-

Find similar trials in Boston, MA

By research site
Beth Israel Deaconess Medical Center· Boston, MADana-Farber Cancer Institute· Boston, MAColumbia University Irving Medical Center· New York, NYMount Sinai Medical Center· New York, NY

Related Studies