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New treatment option for CLL / SLL
Official title A Phase 1 Study of ZE50-0134 in Relapsed and Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, and Select Low-grad Lymphomas
ClinicalTrials.gov ID: NCT06708897
What this study is testing
What is ZE 50-0134?
ZE 50-0134 is an investigational medicine, given as a pill taken by mouth, 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 clinical study aiming to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ZE50-0134 in relapsed and refractory chronic lymphocytic leukemia, small lymphocytic lymphoma, and select low-grad lymphomas.
- 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
- Men and women aged ≥18 years.
- Disease as defined below: Part 1: Patients with symptomatic CLL or SLL (defined by iwCLL) without del(17p)/TP53 must have received ≥2 prior therapies...
- Prior to beginning part 2, an activation amendment will be submitted to the FDA that includes safety, pharmacokinetics, pharmacodynamics and early...
- Absolute neutrophil count (ANC) \> 0.75 x 109/L. For people with documented bone marrow involvement ≥ 0.5 x 109/L
- Platelet count \> 50 x 109/L. For people with documented bone marrow involvement ≥ 30 x 109/L
You likely can't join if
- people will be excluded from the study if they display any of the following criteria:
- FOR PART 2 ONLY \- No prior venetoclax treatment FOR BOTH PARTS ALL THE FOLLOWING APPLY:
- Know active Richter's transformation. Patients who have been treated for this diagnosis and have been in remission for \> 2 years without evidence of...
- Known hypersensitivity to the study drug or excipients of the preparation or any agent given in association with this study.
- Clinically significant cardiac disease including congestive heart failure \> New York Heart Association (NYHA) Class II, evidence for uncontrolled...
- Known Active cytomegalovirus (CMV), hepatitis B or C virus infection.
See the full eligibility criteria
- Men and women aged ≥18 years.
- Disease as defined below: Part 1: Patients with symptomatic CLL or SLL (defined by iwCLL) without del(17p)/TP53 must have received ≥2 prior therapies that have included a BTKi and venetoclax (or declined this) or...
- Prior to beginning part 2, an activation amendment will be submitted to the FDA that includes safety, pharmacokinetics, pharmacodynamics and early how well it works data from the Part 1 portion. At this time, we may...
- Absolute neutrophil count (ANC) \> 0.75 x 109/L. For people with documented bone marrow involvement ≥ 0.5 x 109/L
- Platelet count \> 50 x 109/L. For people with documented bone marrow involvement ≥ 30 x 109/L
- Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) ≤ 3.0 x upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 x ULN
- Creatinine or Cystatin C glomerular filtration rate (GFR) ≥60 mL/min. Estimated GFR (eGFR) according to the Modification of Diet in Renal Disease Study Group (MDRD) formula and expressed in mL/min. To convert...
- Age \>50 years with amenorrhea for at least 12 months or
- Age ≤50 years with 6 months of spontaneous amenorrhea and follicle stimulating hormone (FSH) level within postmenopausal range (\>40 mIU/mL) OR
- Permanently sterilized women (e.g., hysterectomy, bilateral salpingectomy, or uterine ablation) Women and men of reproductive potential must agree to use highly effective contraception when sexually active. This applies...
- people will be excluded from the study if they display any of the following criteria:
- FOR PART 2 ONLY \- No prior venetoclax treatment FOR BOTH PARTS ALL THE FOLLOWING APPLY:
- Know active Richter's transformation. Patients who have been treated for this diagnosis and have been in remission for \> 2 years without evidence of this and who have only CLL are considered eligible
- Known hypersensitivity to the study drug or excipients of the preparation or any agent given in association with this study.
- Clinically significant cardiac disease including congestive heart failure \> New York Heart Association (NYHA) Class II, evidence for uncontrolled coronary artery disease (e.g., unstable angina (anginal symptoms at...
- Known Active cytomegalovirus (CMV), hepatitis B or C virus infection.
- Known Active SARS-CoV-2 infection; prior SARS-CoV-2 infection allowed if completely recovered \> 14 days.
- Active clinically serious infections of Grade \>2, requiring parenteral therapy; people may be eligible after infection resolves.
- Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura within 28 days of enrolment.
- Allogeneic bone marrow transplant within 4 months before first dose of study drug (people must have completed immunosuppressive therapy before enrollment).
- Active cancer that limits expected survival to \< 2 years or requires active therapy concomitant with this treatment. Exclusions would be localized skin cancer, breast cancer, prostate cancer that are resected or...
- A physical exam or laboratory finding that contraindicates the use of investigational therapy or otherwise places the subject at excessively high risk for treatment, as determined by the investigator. A discussion...
- Unresolved toxicity of previous treatments (excluding cases of alopecia) Grade ≥2.
- Requires ongoing immunosuppressive therapy, including systemic (e.g., intravenous or oral) corticosteroids for the treatment of cancer or other conditions. Note: people may use topical or inhaled corticosteroids or...
- Major surgery or significant trauma within 4 weeks before the first dose of study drug.
- Breastfeeding women: breastfeeding women have to discontinue breastfeeding before onset of and during treatment and should be discontinued for at least 3 months after end of treatment.
- people with QTcF \> 470 msec that cannot be corrected with electrolyte replacement, hydration, or medication modifications.
The study team makes the final eligibility decision.
Where it's taking place
- Louisville, Kentucky, United States
- Chapel Hill, North Carolina, United States
- Cincinnati, Ohio, United States
- Columbus, 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 Louisville, Kentucky, United States; Chapel Hill, North Carolina, United States; Cincinnati, Ohio, United States; Columbus, 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.