Status:
COMPLETED
A Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Glofitamab in Combination With Rituximab Plus Ifosfamide, Carboplatin Etoposide Phosphate in Participants With Relapsed/Refractory Transplant or CAR-T Therapy Eligible Diffuse B-Cell Lymphoma
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Diffuse Large B-Cell Lymphoma (DLBCL)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the preliminary efficacy, safety, and pharmacokinetics of glofitamab (glofit) in combination with rituximab plus ifosfamide, carboplatin, and etoposide (R-ICE)...
Eligibility Criteria
Inclusion
- Life expectancy ≥ 12 weeks
- Histologically confirmed B-cell lymphoma
- One line of prior systemic therapy including an anti-CD20 monoclonal antibody (i.e. rituximab) and an anthracycline
- Relapsed or refractory disease after first-line chemoimmunotherapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Participant must be a candidate for high-dose chemotherapy followed by ASCT or CAR-T therapy
Exclusion
- Treatment with more than one prior line of therapy for DLBCL
- Primary mediastinal B-cell lymphoma
- Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3
- Peripheral neuropathy assessed to be Grade \> 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 at enrollment
- Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to first study treatment
- Treatment with monoclonal antibodies for the purposes of treating cancer within 4 weeks prior to first study treatment
- Primary or secondary CNS lymphoma at the time of enrollment or history of CNS lymphoma
- Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
- Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
- Known history of progressive multifocal leukoencephalopathy
- Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or better (with the exception of alopecia and anorexia, or as otherwise permitted by inclusion criteria)
- Prior solid organ transplantation
- Prior allogeneic stem cell transplant
- Prior ASCT for lymphoma
- Prior autologous stem cell transplant for any indication other than lymphoma, within 5 years from the start of study treatment
- Active autoimmune disease requiring treatment
- Prior treatment with systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents), within 4 weeks prior to first dose of study treatment
- Ongoing corticosteroid use \> 30 mg/day of prednisone or equivalent. Participants who received corticosteroid treatment with ≤ 30 mg/day of prednisone or equivalent must be documented to be on a stable dose of at least 4 weeks' duration prior to Cycle 1 Day 1. Participants may have received a brief (≤ 7 days) course of systemic steroids (≤ 100 mg prednisone equivalent per day) prior to initiation of study therapy for control of lymphoma-related symptoms
- Recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis
- Clinically significant history of cirrhotic liver disease
Key Trial Info
Start Date :
November 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2025
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT05364424
Start Date
November 4 2022
End Date
October 15 2025
Last Update
December 1 2025
Active Locations (9)
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1
Chao Family Comprehensive Cancer Center UCI
Orange, California, United States, 92868
2
Memorial Cancer Institute at Memorial West
Pembroke Pines, Florida, United States, 33028
3
The University of Chicago
Chicago, Illinois, United States, 60637
4
Tulane Medical Center
New Orleans, Louisiana, United States, 70112