BridgeMD
Tests treatment safety and results for Lymphoma
Official 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
ClinicalTrials.gov ID: NCT06624085
What this study is testing
What is Glofitamab?
Glofitamab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- At least one bi-dimensionally measurable (\> 1.5 cm) nodal lesion, or one bi-dimensionally measurable (\> 1 cm) extranodal lesion, as measured on CT...
You likely can't join if
- 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)...
See the full eligibility 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...
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- Laguna Hills, California, United States
- Newport Beach, California, United States
- Santa Monica, California, United States
- Washington D.C., District of Columbia, United States
- Orlando, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Kansas City, Kansas, United States
- Bethesda, Maryland, United States
- Santa Fe, New Mexico, United States
- Stony Brook, New York, United States
- Greenville, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- El Paso, Texas, United States
- Houston, Texas, United States
- The Woodlands, Texas, United States
- San Juan, Puerto Rico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States; Laguna Hills, California, United States; Newport Beach, California, United States; Santa Monica, California, United States; Washington D.C., District of Columbia, United States; Orlando, Florida, United States and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.