Clinical trial for Lymphoma
Official title A Phase II Study of Glofitamab Plus Polatuzumab-R-CHP for Patients With High-risk Diffuse Large B-cell Lymphoma
ClinicalTrials.gov ID: NCT05800366
What this study is testing
What is Glofitamab?
Glofitamab is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for lymphoma.
Also referred to as RO7082859.
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 goal of this research study is to evaluate the combination of study drugs, Glofitamab and Polatuzumab, and a standard chemotherapy regimen, R-CHP, as a treatment for high-risk diffuse large B-cell lymphoma. The names of the treatment interventions involved in this study are: Glofitamab (T-cell bispecific antibody) Polatuzumab (antibody-drug conjugate) R-CHP (a chemotherapy regimen comprised of Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, and Prednisone)
- Phase 2: a mid-size study of how well it works
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
- Previously untreated patients with CD20-positive DLBCL, including one of the following diagnoses by 2016 WHO classification of lymphoid neoplasms
- DLBCL, not otherwise specified (NOS)
- T-cell/histiocyte-rich large B-cell lymphoma
- Epstein-Barr virus-positive DLBCL, NOS
- ALK-positive large B-cell lymphoma
You likely can't join if
- Contraindication to any of the individual components of study drugs, including prior receipt of anthracyclines, or history of severe allergic or...
- Prior organ transplantation
- History of indolent lymphoma or current diagnosis of the following: follicular lymphoma grade 3B
- Palliative, short-term treatment with corticosteroids (up to 7 days).
- One cycle of R-CHOP
- Prior radiotherapy to the mediastinal/pericardial region
See the full eligibility criteria
Who can join
- Previously untreated patients with CD20-positive DLBCL, including one of the following diagnoses by 2016 WHO classification of lymphoid neoplasms
- DLBCL, not otherwise specified (NOS)
- T-cell/histiocyte-rich large B-cell lymphoma
- Epstein-Barr virus-positive DLBCL, NOS
- ALK-positive large B-cell lymphoma
- HHV8-positive DLBCL, NOS
- High-grade B-cell lymphoma (HGBCL), NOS
- HGBCL with translocations of MYC and BCL-2, or MYC and BCL-6
- Availability of archival (within 90 days) or freshly collected tumor tissue before study enrollment.
- IPI score of 2-5
- ECOG Performance Status of 0, 1, or 2 (see Appendix A)
- Greater than or equal to 18 years at the time of signing informed consent
- Left ventricular ejection fraction (LVEF) ≥ 50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)
- Hemoglobin ≥ 9.0 g/dL without transfusion for 14 days before first treatment
- ANC ≥ 1,000/μL
- Platelet count ≥ 75,000/μL
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) or \< 3 x ULN in participants with Gilbert's disease
- PT or INR \> 1.5 the ULN in the absence of therapeutic anticoagulation or lupus anticoagulant
- AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional ULN
- Adequate renal function defined by serum creatinine ≤1.5 x ULN or creatinine clearance (by Cockcroft-Gault) ≥ 40 ml/min
- At least one bi-dimensionally FDG-avid measurable lymphoma lesion on PET/CT scan, defined as \> 1.5 cm in its longest dimension on CT scan
- Women of childbearing potential (WOCBP) must agree to use effective contraception when sexually active.
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined below: With female partners of childbearing potential or pregnant...
- For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Ability to understand and the willingness to sign a written informed consent document.
What rules you out
- Contraindication to any of the individual components of study drugs, including prior receipt of anthracyclines, or history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, or...
- Prior organ transplantation
- History of indolent lymphoma or current diagnosis of the following: follicular lymphoma grade 3B; B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma (grey-zone...
- Palliative, short-term treatment with corticosteroids (up to 7 days).
- One cycle of R-CHOP
- Prior radiotherapy to the mediastinal/pericardial region
- Prior treatment with cytotoxic drugs within 5 years of screening for any condition (e.g., cancer, rheumatoid arthritis) or prior use of any anti-CD20 antibody
- Prior use of any monoclonal antibody within 3 months of the start of Cycle 1; any investigational therapy within 28 days prior to the start of Cycle 1
- Corticosteroid use \> 30 mg/day of prednisone or equivalent, for purposes other than lymphoma symptom control.
- Malignancy treated medically or surgically with curative intent and with no known active disease present for ≥2 years before the first dose of study drug
- Adequately treated skin cancer or lentigo maligna without evidence of disease
- Adequately treated carcinoma in situ without evidence of disease.
- Localized prostate cancer and low-risk prostate cancer on active surveillance (Gleason score 6 or below, stage 1 or 2)
- In the opinion of the treating investigator, there is limited potential to interfere with the safety or how well it works of the investigational regimen. Such exceptions must be approved by the principal investigator.
- Lactating or pregnant. Women of childbearing potential must have a pregnancy test performed a maximum of 7 days before the start of treatment, and a negative result must be documented
- Known active infection, or reactivation of a latent infection, whether bacterial, viral; or any major episode of infection requiring hospitalization or treatment with IV antibiotics (for IV antibiotics, this pertains to...
- Known history of HIV or HTLV-1 seropositive status. HTLV-1 testing is required for patients from endemic countries (Japan and Melanesia and countries in the Caribbean basin, South America, Central America, and...
- Clinically significant liver disease including active viral hepatitis infection, cirrhosis, or current alcohol abuse
- Evidence of significant or uncontrolled concomitant diseases that could affect compliance to the protocol or interpretation of the results including significant or extensive history of cardiovascular disease such as New...
- Known history of central nervous system or neurologic disease including stroke or intracranial hemorrhage within 3 months prior to enrollment or seizure disorder
- Grade 2 or greater peripheral neuropathy at baseline or demyelinating form of Charcot-Marie-Tooth disease
- Major surgery within 4 weeks prior to the start or cycle 1 other than for diagnosis
- Active autoimmune disease requiring therapy. Patients with autoimmune thyroid disease on a stable dose of thyroid replacement or type 1 diabetes on a stable dose of insulin are eligible.
- Known or suspected history of HLH.
The study team makes the final eligibility decision.
Where it is enrolling
- Miami, Florida, United States
- Boston, Massachusetts, United States
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, but 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?
This study is enrolling now at Miami, Florida, United States; Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.