BridgeMD
New treatment option for CLL/SLL
Official title Study of APG-2575 as a Single Agent or in Combination With Other Therapeutic Agents for CLL/SLL
ClinicalTrials.gov ID: NCT04215809
What this study is testing
What is Lisaftoclax?
Lisaftoclax is an investigational medicine, given as an once-daily, 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
- Assess the safety and tolerability, identify dose-limiting toxicities (DLT) and determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D) of lisaftoclax.
- 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 to 85
You may be able to join if
- ≥18 years of age.
- Histologically confirmed chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) according to the 2018 international workshop (IW) CLL...
- Eastern Cooperative Oncology Group (ECOG) ≤ 2.
- Patient must have objectively documented evidence of disease progression prior to study entry such as: escalating lymphocytes count with an increase...
- Adequate bone marrow function independent of growth factor:
You likely can't join if
- Patient has undergone allogeneic stem cell transplant \< 90 days.
- Patient has active graft-versus-host disease or require immunosuppressive therapy.
- Patient has undergone CAR-T cell therapy \< 30 days.
- Richter's Syndrome (patients with previously treated Richter's syndrome will be permitted if they are in remission).
- Prior anti-BCL-2 treatment (except patients who discontinued treatment for reasons other than disease progression and patients in the lisaftoclax...
- For the acalabrutinib and lisaftoclax combination cohort: (1) Patients who discontinued due to acalabrutinib toxicity (Note: Patients who received a...
See the full eligibility criteria
Who can join
- ≥18 years of age.
- Histologically confirmed chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) according to the 2018 international workshop (IW) CLL criteria who must have relapsed or be refractory to at least one...
- Eastern Cooperative Oncology Group (ECOG) ≤ 2.
- Patient must have objectively documented evidence of disease progression prior to study entry such as: escalating lymphocytes count with an increase \> 50% over a period of two months or doubling time in less than 6...
- Adequate bone marrow function independent of growth factor:
- Absolute neutrophil count (ANC) ≥1.0× 109/L in patient without bone marrow involvement. This criterion does not apply to patients with bone marrow involvement by CLL/SLL.
- Platelets count ≥30 x 109/L (entry platelet count must be independent of transfusion within 7 days of first dose of lisaftoclax).
- Adequate renal and hepatic function as indicated by:
- Serum creatinine ≤1.5×upper limit of normal (ULN); if serum creatinine is \>1.5×ULN, creatinine clearance must be ≥ 50 mL/min, calculated using the Cockcroft and Gault formula(140-Age)x mas (kg)/(72x creatinine mg/dL)...
- Total bilirubin ≤1.5 x ULN, except patients with known Gilbert's syndrome.
- Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) \<2.5 x ULN, Alkaline phosphatase\<2.5×ULN.
- International normalized Ratio (INR), Prothrombin Time (PT) or Activated Partial Thromboplastin time (APTT) ≤1.5×ULN unless the patient is receiving anticoagulant therapy as long as PT or APTT is within therapeutic...
- Females of childbearing potential (i.e., not postmenopausal for at least 2 years or surgically sterile) must have negative results for pregnancy test performed:
- At screening on a serum sample obtained within 14 days prior to the first lisaftoclax administration;
- Prior to dosing on a urine sample obtained on the first day of lisaftoclax administration, if it has been \>7 days since obtaining the serum pregnancy test results.
- Females of childbearing potential and non-sterile males must practice at least one of the following methods of birth control with partner(s) throughout the study and for 90 days after discontinuing lisaftoclax:
- Total abstinence from sexual intercourse as the preferred lifestyle of the patient; periodic abstinence is not acceptable;
- Surgically sterile partner(s); acceptable sterility surgeries are: vasectomy, bilateral tubal ligation, bilateral oophorectomy or hysterectomy
- Intrauterine device (IUD);
- Double-barrier method (contraceptive sponge, diaphragm or cervical cap with spermicidal fellies or cream AND a condom);
- Hormonal contraceptives (oral, parenteral, vaginal ring or transdermal) for at least 3 months prior to lisaftoclax administration. If hormonal contraceptives are used, the specific contraceptive must have been used for...
- Male patients must refrain from sperm donation, from initial lisaftoclax administration until 90 days after the last dose of lisaftoclax.
- Ability to understand and willingness to sign a written informed consent form (the consent form must be signed by the patient prior to any study-specific procedures).
- Willingness and ability to comply with study procedures and follow-up examination.
What rules you out
- Patient has undergone allogeneic stem cell transplant \< 90 days.
- Patient has active graft-versus-host disease or require immunosuppressive therapy.
- Patient has undergone CAR-T cell therapy \< 30 days.
- Richter's Syndrome (patients with previously treated Richter's syndrome will be permitted if they are in remission).
- Prior anti-BCL-2 treatment (except patients who discontinued treatment for reasons other than disease progression and patients in the lisaftoclax plus acalabrutinib cohort).
- For the acalabrutinib and lisaftoclax combination cohort: (1) Patients who discontinued due to acalabrutinib toxicity (Note: Patients who received a BTK inhibitor therapy may participate whether, or not, they progressed...
- Active pathogen infections including human immunodeficiency virus syndrome (HIV) infection.
- Active hepatitis B infection, as defined seropositivity for Hep B surface antigen (HBsAg) or known active Hepatitis C infection as determined by Hepatitis C antibody with elevated liver enzymes as defined in the...
- Has known central nervous system (CNS) involvement.
- Prior malignancy that required treatment and has shown recurrence within 2 years of screening (except for non-melanoma skin cancer or adequately treated carcinoma in situ of cervix or breast). Cancer treated within 2...
- Concurrent treatment with any other investigational agent, received biologics (≤28 days), or small molecule targeted therapies (≤5 half-life) or other anti-cancer therapies (including chemotherapy) ≤14 days of first...
- Patient is pregnant or breast feeding.
- Has received the following within 7 days prior to the first dose of lisaftoclax:
- Steroid therapy at a dose greater than prednisone 20 mg daily (or equivalent) for anti-neoplastic intent
- CYP3A inhibitors such as fluconazole, ketoconazole, and clarithromycin
- Potent CYP3A inducers such as rifampin, carbamazepine, phenytoin, and St. John's wort.
- Radiation within 14 days of study entry.
- Continuance of toxicities due to prior radiotherapy or chemotherapy agents that have not recovered to ≤ grade 1 or baseline, except alopecia or neuropathy.
- Failure to recover adequately, as judged by the Investigator, from prior surgical procedures. For example, patients with active wound healing; patients who have had major surgery within 28 days from 1st dose of...
- Has a cardiovascular disability status of New York Heart Association Class ≥ 2. Class 2 is defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity results in fatigue...
- Unstable angina or myocardial infarction within 3 months of enrollment.
- QTc interval\> 480ms (Bazett or Fredericia formulae) or other remarkable abnormal ECG findings, including second-degree type II atrioventricular block, third-degree atrioventricular block or bradycardia (ventricular...
- Unable to swallow capsules or have gastrointestinal conditions that could affect the absorption of lisaftoclax in the opinion of the Investigator.
- Uncontrolled concurrent illness including, but not limited to: uncontrolled diabetes mellitus, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations...
- Any other condition or circumstance that would, in the opinion of the Investigator, make the patient unsuitable for participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Jacksonville, Florida, United States
- Boston, Massachusetts, United States
- Charlotte, North Carolina, United States
- Canton, Ohio, United States
- Cleveland, Ohio, United States
- Seattle, Washington, United States
- Brisbane, Queensland, Australia
- Melbourne, Victoria, Australia
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 to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Jacksonville, Florida, United States; Boston, Massachusetts, United States; Charlotte, North Carolina, United States; Canton, Ohio, United States; Cleveland, Ohio, United States and 3 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.