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New treatment option for Relapsed/Refractory (R/R) Mature B Cell Non Hodgkin Lymphoma (NHL)
Official title A Study of ARV-393 in Relapsed/Refractory Non-Hodgkin Lymphoma.
ClinicalTrials.gov ID: NCT06393738
What this study is testing
What is ARV-393?
ARV-393 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for relapsed/refractory (r/r) mature b cell non hodgkin lymphoma (nhl).
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
- This clinical trial is studying the safety and potential anti-tumor activity of an investigational drug called ARV-393 in patients diagnosed with advanced Relapsed/Refractory non-Hodgkin's lymphoma (R/R NHL) to determine if ARV-393 may be a possible treatment option. ARV-393 is thought to work by breaking down a protein present in many types of non-Hodgkins lymphomas, which may prevent, slow or stop tumor growth.
- 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
- For Part A and B: Have relapsed/refractory NHL and \>=2 prior systemic therapies, (including rituximab), and be ineligible for known therapies with...
- For Part C and D: Have R/R DLBCL, not otherwise specified [NOS (DLBCL, NOS)] or large B-cell lymphoma (LBCL) arising from follicular lymphoma and...
- Have at least one bi dimensionally measurable lesion \>1.5-centimeter (cm) in largest dimension for nodal or \>1.0 cm for extranodal lesion.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 (NOTE: For Part A only - ECOG PS of 2 is allowed for participants with...
- Adequate bone marrow function
You likely can't join if
- Current or past history of peripheral eosinophilia, hypereosinophilic syndrome (HES), organ-specific eosinophilic disorder, or drug reaction with...
- Prior allogeneic stem cell transplant (SCT) or solid organ transplantation.
- Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, melanoma in...
- Any of the following in the previous 6 months:
- Myocardial infarction, long QT syndrome or family history of long QT syndrome, or Torsade de Pointes;
- Clinically important atrial or ventricular arrhythmias;
See the full eligibility criteria
- For Part A and B: Have relapsed/refractory NHL and \>=2 prior systemic therapies, (including rituximab), and be ineligible for known therapies with demonstrated clinical benefit per investigator assessment or...
- For Part C and D: Have R/R DLBCL, not otherwise specified [NOS (DLBCL, NOS)] or large B-cell lymphoma (LBCL) arising from follicular lymphoma and have received two or more lines of systemic therapy.
- Have at least one bi dimensionally measurable lesion \>1.5-centimeter (cm) in largest dimension for nodal or \>1.0 cm for extranodal lesion.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 (NOTE: For Part A only - ECOG PS of 2 is allowed for participants with secondary CNS lymphoma).
- Adequate bone marrow function
- Adequate kidney function
- Adequate Liver Function
- Current or past history of peripheral eosinophilia, hypereosinophilic syndrome (HES), organ-specific eosinophilic disorder, or drug reaction with eosinophilia and systemic symptoms (DRESS).
- Prior allogeneic stem cell transplant (SCT) or solid organ transplantation.
- Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, melanoma in situ or carcinoma in situ of the breast or cervix, and prostate cancer...
- Any of the following in the previous 6 months:
- Myocardial infarction, long QT syndrome or family history of long QT syndrome, or Torsade de Pointes;
- Clinically important atrial or ventricular arrhythmias;
- Serious conduction system abnormalities, 3rd degree atrioventricular (AV block), unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF), New York Heart Association Class III...
- Cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism, and/or other clinically significant episode of thromboembolic disease;
- Active inflammatory gastrointestinal (GI) disease, chronic diarrhea, previous gastric resection, or lap band surgery.
- Uncontrolled hypertension despite optimal medical treatment
- History of myocarditis.
- In ability to comply with listed prohibited treatments.
- Standard 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
- Cardiac ejection fraction \<45%.
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Detroit, Michigan, United States
- New Brunswick, New Jersey, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Copenhagen, Denmark
- Odense C, Denmark
- El Palmar, Murcia, Spain
- Pamplona, Navarre, Spain
- Barcelona, Spain
- Madrid, Spain
- Salamanca, Spain
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 New Haven, Connecticut, United States; Detroit, Michigan, United States; New Brunswick, New Jersey, United States; New York, New York, United States; Cleveland, Ohio, United States; Nashville, Tennessee, United States and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.