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New treatment option for CLL/SLL
Official title Study of Epcoritamab as a Consolidation Therapy in CLL/SLL
ClinicalTrials.gov ID: NCT07108998
What this study is testing
What is Epcoritamab?
Epcoritamab is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for cll/sll.
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 is a phase 2 study of Epcoritamab as a consolidation therapy for 2nd generation BTKi +/- Obinutuzumab in CLL/SLL patients or patients with variants of this.
- 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
- Diagnosis of CLL or SLL meeting the established 2018 iwCLL diagnostic criteria or variant of CLL/SLL and has received a 2nd generation BTKi...
- Attainment of Partial Response or greater with a 2nd generation BTKi (acalabrutinib or zanubrutinib) +/- obinutuzumab but detectable disease in blood...
- Age ≥18 years.
- ECOG performance status ≤2 (or Karnofsky ≥60%, see Appendix D).
- Patients must have adequate organ and marrow function as defined below: Absolute neutrophil count ≥1,000/mcL, unless if neutropenia is due to...
You likely can't join if
- Obtaining a CR or nodal PR with no detectable disease in blood or bone marrow after treatment with a 2nd generation BTKi (acalabrutinib or...
- Absence of CD20 expression on CLL cells at pre-treatment.
- Received any prior treatment ever with a CD3×CD20 bispecific antibody.
- Organ transplant recipients are excluded except those with no active graft versus host disease (GVHD) requiring treatment within 12 months of...
- Receipt of a live vaccine within 28 days prior to study treatment initiation.
- Autoimmune diseases requiring high dose immunosuppressives (e.g., above 20 mg prednisone daily).
See the full eligibility criteria
Who can join
- Diagnosis of CLL or SLL meeting the established 2018 iwCLL diagnostic criteria or variant of CLL/SLL and has received a 2nd generation BTKi (acalabrutinib or zanubrutinib) +/- obinutuzumab for a minimum of 12 months as...
- Attainment of Partial Response or greater with a 2nd generation BTKi (acalabrutinib or zanubrutinib) +/- obinutuzumab but detectable disease in blood or bone marrow by NGS ClonoSEQ.
- Age ≥18 years.
- ECOG performance status ≤2 (or Karnofsky ≥60%, see Appendix D).
- Patients must have adequate organ and marrow function as defined below: Absolute neutrophil count ≥1,000/mcL, unless if neutropenia is due to underlying CLL bone marrow disease. Hemoglobin ≥8 g/dl unless if related to...
- Women of childbearing potential and non-sterile males must practice at least 1 of the following methods of birth control with their partner(s) throughout the study and for 4 months after discontinuing study drug:
- Total abstinence from sexual intercourse as the preferred lifestyle of the patient; periodic abstinence is not acceptable.
- Surgically sterile partner(s) by vasectomy, bilateral orchiectomy, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy.
- Intrauterine device.
- Hormonal contraceptives (oral, parenteral, vaginal ring or transdermal) for at least 1-month prior to study drug administration.
- Women of childbearing potential must have a negative pregnancy result as follows: At Screening on a serum sample obtained within 7 days prior to the first study drug administration. If a urine pregnancy test at any...
- Non-sterile males must refrain from sperm donation, from initial study drug administration until 4 months after the last dose of study drug.
- Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
What rules you out
- Obtaining a CR or nodal PR with no detectable disease in blood or bone marrow after treatment with a 2nd generation BTKi (acalabrutinib or zanubrutinib) +/- obinutuzumab as assessed by Adaptive's NGS ClonoSEQ.
- Absence of CD20 expression on CLL cells at pre-treatment.
- Received any prior treatment ever with a CD3×CD20 bispecific antibody.
- Organ transplant recipients are excluded except those with no active graft versus host disease (GVHD) requiring treatment within 12 months of beginning treatment on study.
- Receipt of a live vaccine within 28 days prior to study treatment initiation.
- Autoimmune diseases requiring high dose immunosuppressives (e.g., above 20 mg prednisone daily).
- Central nervous system (CNS) disease(s) unless in the opinion of the investigator these would not preclude the patient from participation.
- Known hypersensitivity to any of the components of the treatment drugs (see Investigators Brochure for a list of components).
- Patients with active Richter's transformation. a. Note: the following will be eligible and not excluded: patients with accelerated phase or prolymphocytic progression
- Patients who have received prior radiation therapy (RT) unless in the opinion of the investigator the prior receipt of RT will not adversely impact the patient's ability to participate.
- Patients who require anti-coagulation with warfarin or equivalent Vitamin K antagonist.
- Major surgery within 14 days prior to the first dose of study drug.
- Patient has significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 180 days prior to the first dose of study drug, or any Class 3 or...
- Pregnant women, those planning to become pregnant during the study, and/or breastfeeding women are ineligible for participation.
- Patient exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds). No new IV therapy or intravenous antibiotics may be initiated within 2 weeks prior to first...
- Known poorly controlled human immunodeficiency virus (HIV) or active hepatitis B or C infection (active hepatitis B defined as HBsAg positive, or HBcAb positive with detectable HBV DNA load; active hepatitis C defined...
- Unexplained fever \> 38.3°C within 7 days prior to the first dose of study drug administration (if the fever is considered attributed to the patient's malignancy or an explained infection, the Patient may be enrolled at...
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessment of the investigational regimen in the opinion of the...
The study team makes the final eligibility decision.
Where it's taking place
- Cincinnati, Ohio, 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 - 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 Cincinnati, Ohio, United States. 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.