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Trial Title:
A Study Evaluating the Safety and Efficacy of Glofitamab + Gemcitabine + Oxaliplatin in U.S. Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
NCT ID:
NCT06624085
Condition:
Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Large B-Cell, Diffuse
Gemcitabine
Oxaliplatin
Obinutuzumab
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Glofitamab
Description:
Participants will receive IV glofitamab for up to 12 cycles (cycle length = 21 days)
Arm group label:
Gemcitabine + Glofitamab + Oxaliplatin
Intervention type:
Drug
Intervention name:
Tocilizumab
Description:
Participants will receive IV tocilizumab as needed to manage cytokine release syndrome
(CRS)
Arm group label:
Gemcitabine + Glofitamab + Oxaliplatin
Intervention type:
Drug
Intervention name:
Obinutuzumab
Description:
Participants will receive IV obinutuzumab pretreatment
Arm group label:
Gemcitabine + Glofitamab + Oxaliplatin
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Participants will receive IV gemcitabine for up to 8 cycles (cycle length = 21 days)
Arm group label:
Gemcitabine + Glofitamab + Oxaliplatin
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
Participants will receive IV oxaliplatin for up to 8 cycles (cycle length = 21 days)
Arm group label:
Gemcitabine + Glofitamab + Oxaliplatin
Summary:
The purpose of the study is to evaluate glofitamab + gemcitabine + oxaliplatin in
participants in the United States, including under-represented racial and ethnic
populations, that have relapsed or refractory (R/R) diffuse large B-cell lymphoma
(DLBCL).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically confirmed DLBCL, not otherwise specified (NOS)
- Relapsed (disease that has recurred following a response that lasted ≥ 6 months
after completion of the last line of therapy) or refractory ( disease that did not
respond to or that progressed < 6 months after completion of the last line of
therapy) disease
- At least one prior line of systemic therapy
- Participants who have failed only one prior line of therapy must not be a candidate
for high-dose chemotherapy followed by autologous stem cell transplant (ASCT)
- At least one bi-dimensionally measurable (> 1.5 cm) nodal lesion, or one
bi-dimensionally measurable (> 1 cm) extranodal lesion, as measured on CT scan
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
Exclusion Criteria:
- Prior enrollment in Study GO41944 (STARGLO; NCT04408638)
- Participant has failed only one prior line of therapy and is a candidate for stem
cell transplantation
- History of transformation of indolent disease to DLBCL
- High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and
high-grade B-cell lymphoma NOS, as defined by 2016 WHO guidelines
- Primary mediastinal B-cell lymphoma
- History of severe allergic or anaphylactic reactions to humanized or murine
monoclonal antibodies (or recombinant antibody-related fusion proteins) or known
sensitivity or allergy to murine products
- Prior treatment with glofitamab or other bispecific antibodies targeting both CD20
and CD3
- Prior treatment with gemcitabine or oxaliplatin
- Peripheral neuropathy or paresthesia assessed to be Grade >/= 2 according to 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 recruitment or history of CNS
lymphoma
- Prior CNS involvement that has been definitively treated and confirmed via MRI or
cerebrospinal fluid analysis to be in complete remission is permissible
- Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or
neurodegenerative disease
- History of other primary malignancy, with exceptions defined by the protocol
- Significant or extensive cardiovascular disease, or significant pulmonary disease
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection
(exclusing fungal infections of nail beds) at study enrollment or any major episode
of infection within 4 weeks prior to the first study treatment
- Documented severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
within 6 months of first study treatment, or positive SARS-CoV-2 test within 7 days
prior to enrollment
- Suspected or latent tuberculosis
- Positive test results for hepatitis B (HBV) or hepatitis C (HCV)
- Known or suspected chronic active Epstein-Barr viral infection
- Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
- Known history of progressive multifocal leukoencephalopathy
- Prior solid organ transplantation
- Prior allogenic stem cell transplant
- Active autoimmune disease requiring treatment
- Prior treatment with systemic immunosuppressive medications within 4 weeks prior to
first dose of study treatment
- Ongoing systemic corticosteroid use which, in the opinion of the investigator, puts
the patient at increased risk of steroid-related iatrogenic adrenal insufficiency
- Recent major surgery (within 4 weeks before the first study treatment) other than
for diagnosis
- Clinically significant history of cirrhotic liver disease
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
November 15, 2024
Completion date:
January 14, 2030
Lead sponsor:
Agency:
Hoffmann-La Roche
Agency class:
Industry
Source:
Hoffmann-La Roche
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06624085
