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NCT05364424 | Recruiting | Diffuse Large B-Cell Lymphoma (DLBCL)

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
Sponsor:

Hoffmann-La Roche

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) in participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have failed one prior line of therapy incorporating an anti-cluster of differentiation (CD) 20 antibody (i.e., rituximab) and an anthracycline, and who are transplant or chimeric antigen receptor T-cell (CAR-T) therapy eligible, defined as being medically eligible for intensive platinum-based salvage therapy followed by autologous stem cell transplantation (ASCT) or for CAR-T therapy.

Condition or disease

Diffuse Large B-Cell Lymphoma (DLBCL)

Intervention/treatment

Glofitamab

Obinutuzumab

Tocilizumab

Rituximab

Ifosfamide

Carboplatin

Etoposide

Phase

Phase 1

Study Type : Interventional
Estimated Enrollment : 40 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : A Phase IB, Open-Label, Multicenter, Single Arm Study Evaluating the Preliminary Efficacy, Safety, and Pharmacokinetics of Glofitamab in Combination With Rituximab Plus Ifosfamide, Carboplatin Etoposide Phosphate in Patients With Relapsed/Refractory Transplant or CAR-T Therapy Eligible Diffuse B-Cell Lymphoma
Actual Study Start Date : November 4, 2022
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024
Arm Intervention/treatment

Experimental: R/R DLBCL

Participants will receive up to 3 21-day cycles of glofitamab, rituximab, ifosfamide, carboplatin, and etoposide (glofit-R-ICE).

Drug: Glofitamab

Mate: Obinutuzumab

Drug: Tocilizumab

Drug: Rituximab

Drug: Ifosfamide

Drug: Carboplatin

Drug: Etoposide
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • 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 Criteria
  • 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
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

Location Details

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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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Active, not recruiting

United States, California

Chao Family Comprehensive Cancer Center UCI

Orange, California, United States, 92868

Active, not recruiting

United States, Florida

Memorial Cancer Institute at Memorial West

Pembroke Pines, florida, United States, 33028

Recruiting

United States, Illinois

The University of Chicago

Chicago, Illinois, United States, 60637

Active, not recruiting

United States, Louisiana

Tulane Medical Center; Investigational/Research Pharmacy

New Orleans, Louisiana, United States, 70112

Recruiting

United States, Massachusetts

UMASS Memorial Medical Center

Worcester, Massachusetts, United States, 01655

Recruiting

United States, New York

New York University Langone Medical Center

New York, New York, United States, 10016

Active, not recruiting

United States, Ohio

Cleveland Clinic Foundation; Cleveland Clinic Cancer Center/I40

Cleveland, Ohio, United States, 44195

Recruiting

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Recruiting

United States, Wisconsin

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226