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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Group 1d: Relapsed or refractory ALL with dexamethasone run-in [5 days, dexamethasone 10mg/m2 (divided BID)]; Or r/r ALL in remission but with detectable MRD (MRD +) by any detection method per institution standard of practice; IT chemo (per institutional SOC) is permitted prior to LP-118 C1D1 dosing, and then concomitantly on treatment if in best interest of the subject; Relapsed or refractory ALL subjects with B cell phenotype who have received at least two prior therapeutic regimens (such as multi-agent chemotherapy and/or tyrosine kinase inhibitors including bosutinib, dasatinib, imatinib, nilotinib or ponatinib) and failed, or are currently ineligible/intolerant for CD19-based target therapy (e.g. Blinatumomab); Relapsed or refractory ALL subjects with T cell phenotype who have received at least one prior therapy and failed. Relapsed or refractory ALL subjects with age between 13 - 18 years and have body weight ≥ 40kg, ALL subjects with B cell phenotype who have received at least two prior therapeutic regimens (such as multi-agent chemotherapy and/or tyrosine kinase inhibitors including bosutinib, dasatinib, imatinib, nilotinib or ponatinib) and progressed, or are currently ineligible/intolerant for CD19-based target therapy (e.g. Blinatumomab); Relapsed or refractory ALL subjects with T cell phenotype who have received at least one prior therapy and progressed;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at cycle 0 day 1, cycle 1 day 1, cycle 1 day 2, cycle 1 day 15, cycle 1 day 16, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1, cycle 5 day 1, cycle 6 day 1, cycle 7 day 1, cycle 8 day 1, cycle 9 day 1 (28-day cycles)
Awards & highlights
Study Summary
This trial is testing a new drug to see if it is safe and tolerated. Up to 100 people will be given the drug daily to see how they react.
Who is the study for?
Adults with various advanced blood cancers like CLL, SLL, ALL, AML, and others who have tried at least one or two prior treatments without success can join this trial. It's also open to certain adolescents (13-18) with B cell ALL if they weigh over 40 kg. Participants need good heart function and adequate bone marrow, liver, and kidney function.Check my eligibility
What is being tested?
LP-118 is an oral medication being tested in a Phase 1 clinical trial for safety and how the body processes it. The study has two parts: first finding the right dose (Phase 1a), then giving that dose to more people to learn more about its effects (Phase 1b).See study design
What are the potential side effects?
Since LP-118 is new and this is a Phase 1 trial designed to assess safety, specific side effects are not yet fully known but may include typical reactions related to cancer medications such as fatigue, digestive issues or changes in blood counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have ALL that has come back or didn't respond to treatment, and I've tried at least two (or one for T cell) previous therapies.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at cycle 0 day 1, cycle 1 day 1, cycle 1 day 2, cycle 1 day 15, cycle 1 day 16, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1, cycle 5 day 1, cycle 6 day 1, cycle 7 day 1, cycle 8 day 1, cycle 9 day 1 (28-day cycles)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at cycle 0 day 1, cycle 1 day 1, cycle 1 day 2, cycle 1 day 15, cycle 1 day 16, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1, cycle 5 day 1, cycle 6 day 1, cycle 7 day 1, cycle 8 day 1, cycle 9 day 1 (28-day cycles)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD)
Pharmacokinetic (PK) profile of LP-118: Area Under the Curve (AUC) of LP-118
Pharmacokinetic (PK) profile of LP-118: Maximum Plasma Concentration (Cmax)
+2 moreSecondary outcome measures
Duration of Response (DOR)
Overall Survival (OS)
Progression-Free Survival (PFS)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Dose Expansion PhaseExperimental Treatment1 Intervention
Additional subjects will be recruited to further explore the safety, tolerability, PK, and efficacy in specific subject subgroups. One or more RP2D may be explored. Definition of these cohorts will be accomplished by protocol amendment, and in light of emerging data from Phase 1a.
Group II: Dose Escalation PhaseExperimental Treatment1 Intervention
Phase 1a dose-escalation will begin with group 1 and proceed until DLT is observed and MTD is established, or until an RP2D is established. Subjects enrolled in the dose cohorts will follow the 3+3 study design, starting with an accelerated step-up dosing schedule (with a starting dose of 20 mg, 50 mg, 100 mg once daily) until they reach the designated target dose (50 mg, 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, 800 mg). Once the MTD or RP2D is established for group 1, the phase 1a dose escalation can proceed for group 2. The starting dose level for group 2 will be one dose level below the MTD or RP2D established for group 1.
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Who is running the clinical trial?
Newave Pharmaceutical IncLead Sponsor
3 Previous Clinical Trials
170 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken strong medication affecting liver enzymes or certain cancer treatments in the last 7 days.Your heart's electrical activity is abnormal, or you have a heart condition that affects your daily activities.My condition is an advanced blood cancer.Criterion: Participants with certain types of advanced or high-risk leukemia or lymphoma who have received several previous treatments and have specific levels of blood cells, heart function, bone marrow, blood clotting, kidney function, and liver function within normal ranges.I am 18 or older, or between 13-18 and weigh at least 40 kg if I have T cell or B cell ALL.My CLL/SLL is low risk, progressed on BTK inhibitors, and I've had at least 2 prior treatments.I have ALL that has come back or didn't respond to treatment, and I've tried at least two (or one for T cell) previous therapies.I haven't had a stem cell transplant in the last 60 days and am not on strong immune system drugs.I have a specific type of non-Hodgkin lymphoma or other listed cancer, have tried at least two treatments, and have no other known beneficial treatment options.I have had cancer other than breast or prostate in the last year, but it's under control.I do not have uncontrolled infections, HIV, hepatitis B or C, or a recent unexplained fever.You have been diagnosed with certain types of blood disorders that have not responded to previous treatments, and your white blood cell count is within a specific range.I haven't had cancer treatments or live vaccines in the last 14 days and have recovered from major side effects.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Expansion Phase
- Group 2: Dose Escalation Phase
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the scope of recruitment for this research experiment?
"Affirmative. According to the data hosted on clinicaltrials.gov, this medical study is actively recruiting participants since it was posted in August 2021 and updated most recently in October 2022. 100 individuals must be enrolled from 7 different medical facilities."
Answered by AI
Are there currently any vacancies for participation in this research project?
"Affirmative, the information posted on clinicaltrials.gov indicates that this study is actively recruiting patients at present. It was initially shared to the public on August 23rd 2021 and has been recently updated as of October 10th 2022. The researchers require 100 participants from 7 separate sites for their trial."
Answered by AI
Has LP-118 passed the required regulatory scrutiny to be sanctioned by the FDA?
"LP-118 has limited clinical data confirming its efficacy and safety, thus receiving a score of 1 on our scale."
Answered by AI
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