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New treatment option for CLL/SLL
Official title Study of Oral Administration of LP-168 in Patients With Relapsed or Refractory B-cell Malignancies.
ClinicalTrials.gov ID: NCT04775745
What this study is testing
What is LP-168?
LP-168 is an investigational medicine, given as an once-daily 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 phase I, multi-center, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and clinical activity of LP-168 in subjects with relapsed or refractory B-cell malignancies. LP-168 is a small molecule inhibitor.
- 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
- A subject will be eligible for study participation if he/she meets the following criteria:
- people are eligible with B-cell malignancies, WM, FL, MCL, MZL, DLBCL, HCL, CLL, SLL, based upon 2016 updated WHO classification. Those people with...
- Low-grade B-cell lymphomas as follicular Grade 1, 2, or 3A, marginal zone or small lymphocytic lymphoma.
- Subject must have adequate coagulation, renal, and hepatic function, per local laboratory reference ranges at Screening as follows:
- Activated partial thromboplastin time (APTT) and prothrombin time (PT) not to exceed 1.5 × ULN
You likely can't join if
- A subject will not be eligible for study participation if he/she meets any of the following criteria.
- Subject has received any of the following therapies within 14 days or 5 half-lives (whichever is shorter) prior to the first dose of study drug, or...
- Any anti-cancer therapy including chemotherapy, biologic or immunotherapy, radiotherapy, etc;
- Any investigational therapy, including targeted small molecule agents.
- For CLL people who come off BCR antagonists (BTK inhibitors, PI3K inhibitors, etc.) treatment, allow washout for 2 days as these people progress...
- people who require immediate cytoreduction. However, people may receive up to two days of steroids for symptoms of impending organ impairment and...
See the full eligibility criteria
- A subject will be eligible for study participation if he/she meets the following criteria:
- people are eligible with B-cell malignancies, WM, FL, MCL, MZL, DLBCL, HCL, CLL, SLL, based upon 2016 updated WHO classification. Those people with WM, FL, MCL, DLBCL, or HCL must have received at least 2 prior systemic...
- Low-grade B-cell lymphomas as follicular Grade 1, 2, or 3A, marginal zone or small lymphocytic lymphoma.
- Subject must have adequate coagulation, renal, and hepatic function, per local laboratory reference ranges at Screening as follows:
- Activated partial thromboplastin time (APTT) and prothrombin time (PT) not to exceed 1.5 × ULN
- Calculated creatinine clearance (CrCl) ≥ 60 mL/min using 24-hour CrCl OR Cockcroft-Gault formula.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 ×ULN; Bilirubin ≤ 1.5 × ULN (except people with Gilbert's Syndrome, who may have a bilirubin \> 1.5 × ULN, per discussion between the...
- people must have adequate bone marrow independent of growth factor support per local laboratory reference range at screening as follows:
- Absolute Neutrophil Count (ANC) ≥1000/uL;
- An exception is for people with an ANC\<1000/uL and bone marrow heavily infiltrated with underlying disease (approximately 60% or more) may use growth factor to achieve the ANC eligibility criteria per discussion...
- Platelet count ≥ 50,000/µL - OR - Platelet count ≥ 20,000/ µL if thrombocytopenia is clearly due to CLL disease under study (per Investigator discretion)
- Hemoglobin ≥8.0g/dL, and can be achieved by transfusion
- A subject will not be eligible for study participation if he/she meets any of the following criteria.
- Subject has received any of the following therapies within 14 days or 5 half-lives (whichever is shorter) prior to the first dose of study drug, or has not recovered to ≤ Grade 1 clinically significant adverse...
- Any anti-cancer therapy including chemotherapy, biologic or immunotherapy, radiotherapy, etc;
- Any investigational therapy, including targeted small molecule agents.
- For CLL people who come off BCR antagonists (BTK inhibitors, PI3K inhibitors, etc.) treatment, allow washout for 2 days as these people progress quickly after treatment discontinuation and then remain eligible (steroids...
- people who require immediate cytoreduction. However, people may receive up to two days of steroids for symptoms of impending organ impairment and remain eligible.
- Subject has received the following medications or therapies within 7 days prior to the first dose of study drug:
- Steroid therapy (at dosages equivalent to prednisone \>20 mg/day) for anti-neoplastic intent (except as noted in exclusion criteria #3);
- Cytochrome P450, family 3, subfamily A (CYP3A4) strong inhibitors and strong CYP2C8 inducers/inhibitors.
- Potent CYP3A4 inducers such as rifampin, carbamazepine, phenytoin, and St. John's wort.
- people require treatment with systemic acid-reducing agents including H-2-receptor antagonists and proton pump inhibitors with the following exceptions:
- Proton pump inhibitors should be discontinued at least 7 days prior and held throughout the study
- If concurrent use of an H2 blocking agent is necessary, it must be administered only between 2 and 3 hours after the dose of LP-168. If not taken during this time, the dose of H2 blocking agents should not be taken...
- If concurrent use of a local antacid is necessary, it must be administered 2 or more hours before and/or 2 or more hours after the dose of LP-168.
- Subject has significant screening electrocardiogram (ECG) abnormalities including. 2nd degree AV block type II 3rd degree block, Grade 2 or higher bradycardia, and corrected QT interval (QTc) ≥ 480ms.
- Serum amylase \> 1.5 × ULN or serum lipase \> 1.5 × ULN.
- Subject has any history of Richter's transformation for Phase 1a portion of the trial.
- people who have undergone autologous/allogeneic hematopoietic stem cell transplantation (HSCT) therapy within 90 days of the first dose of LP-168, or patients on immunosuppressive therapy post-HSCT at the time of...
- Subject has a history of other active malignancies other than B-cell malignancies within the past 3 years prior to study entry, with the exception of:
- Adequately treated in situ carcinoma of the cervix uteri;
- Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
- Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
- Subject requires anticoagulation with Warfarin.
The study team makes the final eligibility decision.
Where it's taking place
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Salt Lake City, Utah, 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 Durham, North Carolina, United States; Cincinnati, Ohio, United States; Columbus, Ohio, United States; Salt Lake City, Utah, 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.