Lanraplenib for Relapsed Acute Myelogenous Leukemia (AML)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of California Los Angeles (UCLA), Los Angeles, CA
Relapsed Acute Myelogenous Leukemia (AML)+5 More
Lanraplenib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

A Study to Evaluate Lanraplenib (LANRA) in Combination With Gilteritinib in Participants With FLT3-mutated Relapsed or Refractory Acute Myeloid Leukemia (AML)

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Eligible Conditions

  • Relapsed Acute Myelogenous Leukemia (AML)
  • Acute Myeloid Leukemia (AML)
  • Refractory Acute Myelogenous Leukemia (AML)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Relapsed Acute Myelogenous Leukemia (AML)

Study Objectives

This trial is evaluating whether Lanraplenib will improve 5 primary outcomes and 8 secondary outcomes in patients with Relapsed Acute Myelogenous Leukemia (AML). Measurement will happen over the course of Cycle 1 Day 1 through pre-dose Cycle 2 Day 1 (cycle is 28 days).

Year 5
Part 1 and 2: Number of Participants who Experience a Treatment-Emergent Adverse Event (TEAE)
Part 1 and Part 2: Number of Participants who Experience a Treatment-Emergent Adverse Event (TEAE)
Day 28
Part 1: Area Under the Plasma Concentration x Time Curve from Hour 0 to the Last Measurable Time Point (AUC0-last) of Lanraplenib (LANRA)
Part 1: Maximal Plasma Concentration (Cmax) of Lanraplenib (LANRA)
Part 1: Maximally Tolerated Dose (MTD) of Lanraplenib (LANRA)
Part 1: Recommended Phase 2 Dose (RP2D) of Lanraplenib (LANRA)
Part 1: Time to Maximal Plasma Concentration (Tmax) of Lanraplenib (LANRA)
Day 28
Part 1 and Part 2: Number of Participants who Experience a Dose-Limiting Toxicity (DLT) for Lanraplenib (LANRA)
Up to 5 years
Part 1 and Part 2: Composite Complete Response (CR) Rate
Part 1 and Part 2: Composite Complete Response (CR) with Partial Hematologic Recovery (CRh)
Part 1 and Part 2: Duration of Response (DoR)
Part 1 and Part 2: Event Free Survival (EFS)
Part 1 and Part 2: Overall Survival (OS)

Trial Safety

Safety Progress

1 of 3

Other trials for Relapsed Acute Myelogenous Leukemia (AML)

Trial Design

2 Treatment Groups

Part 1: Dose Escalation
1 of 2
Part 2: Expansion Cohort
1 of 2
Experimental Treatment

This trial requires 55 total participants across 2 different treatment groups

This trial involves 2 different treatments. Lanraplenib is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Part 1: Dose EscalationSequential cohorts of participants will receive escalating doses of lanraplenib (LANRA) once daily (QD) + gilteritinib QD in each 28 day cycle for determination of the maximally tolerated dose (MTD) / recommended Phase 2 dose (RP2D) of LANRA in combination with gilteritinib.
Part 2: Expansion CohortFollowing identification of the maximally tolerated dose (MTD) / recommended Phase 2 dose (RP2D) of lanraplenib (LANRA) in combination with gilteritinib in Part 1, an expansion cohort will enroll. The expansion cohort will receive LANRA in combination with gilteritinib at the MTD / RP2D once daily (QD) in each 28 day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lanraplenib
Not yet FDA approved
Gilteritinib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 5 years for reporting.

Closest Location

University of California Los Angeles (UCLA) - Los Angeles, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Relapsed Acute Myelogenous Leukemia (AML) or one of the other 5 conditions listed above. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Adults ≥18 years of age with acute myeloid leukemia (AML) and at least 1 prior line of therapy
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2
Adequate hepatic and renal function
Prothrombin time (PT), activated partial thromboplastin time (aPTT) and international normalized ratio (INR) ≤1.5x upper limit of normal (ULN) unless receiving therapeutic anticoagulation
Negative serum ß-human chorionic gonadotropin (HCG) test in women of child-bearing potential (WOCBP)
You have FLT3-mutated disease documented in a local reference laboratory. show original
You have the ability to understand the requirements and procedures of the study and sign a written informed consent form. show original
You have a left ventricular ejection fraction (LVEF) of 50% or more. show original

Patient Q&A Section

What causes leukemia?

"Very good question. There are many potential causes of leukemia, but only a few are known to be multiple times more dangerous. All the other causes are single occurrences that may occur at any age, and those who get them have a better chance at curing themselves than others who don't. What we know is that all of these sorts of things can happen to people with no obvious reason at all\n" - Anonymous Online Contributor

Unverified Answer

Can leukemia be cured?

"There is no cure for leukemia. There are many types of treatments that may help the patients live longer.  The most important thing is to follow up the people with leukemia and check if they need help.  Facing with all the problems of leukemia, sometimes we don’t know what is happening. It is best to consult a physician who has experience with leukemia.  There is also an online site on leukemia for more information.  http://www.leukemia-info." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing leukemia?

"There are no absolute risks associated with developing leukemia. However, there are some individuals who are more prone to developing this disease compared to others. Every patient should receive a complete medical history and evaluation, including routine laboratory tests, plain radiographs, CT scan, MRI, hearing test and so on, to help determine their risk of developing leukemia. When considering treatment for leukemia, the type of leukemia must be considered along with the individual's age, overall health, and lifestyle. If leukemia develops, then treatments tailored to the individual are needed." - Anonymous Online Contributor

Unverified Answer

What does lanraplenib usually treat?

"Lanraplenib seems to be effective in treating patients with relapsed or refractory acute lymphoblastic leukemia who have received at least 2 prior systemic chemotherapy regimens. The most common adverse effects (>10% incidence) were grade 3/4 diarrhea (16%) and fatigue (14%). No patient had to discontinue therapy due to any adverse event." - Anonymous Online Contributor

Unverified Answer

Does lanraplenib improve quality of life for those with leukemia?

"Adding lanraplenib to standard vincristine, daunorubicin, and cyclophosphamide regimens improves both efficacy and tolerability. Lanraplenib also appears to improve QOL, particularly in patients with relapsed/refractory disease." - Anonymous Online Contributor

Unverified Answer

What is leukemia?

"Leukemias are a group of tumors of the bone marrow, blood and/or lymphatics. They include multiple myeloma, acute lymphocytic leukemia, T-cell lymphomas, B-cell lymphomas, blast crisis in acute myeloid leukaemia, chronic myelomonocytic leukaemia and chronic neutrophilic leukaemia. There is a spectrum of cellular abnormality in leukemia. So called ‘staging’ aims to provide information about the degree of progress the tumor has made before it is diagnosed as ‘advanced’ or had 'invaded' regional lymph nodes or distant sites. Even then, there is still considerable variation between patients in response to treatment." - Anonymous Online Contributor

Unverified Answer

What is the latest research for leukemia?

"It's important to notice that there is a lot more research being done than what is currently being published on the Internet. This includes many studies on leukemogenesis\n" - Anonymous Online Contributor

Unverified Answer

Has lanraplenib proven to be more effective than a placebo?

"Lanraplenib treatment was found to be significantly more effective than placebo in patients with advanced-stage ALK-positive metastatic ALK-positive lung adenocarcinoma receiving first-line therapy. ClinicalTrials.gov identifier: NCT02596015." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in lanraplenib for therapeutic use?

"Lanraplenib is effective against smaller subpopulations of AML patients who have certain molecular or clinical markers of poor prognosis. Among these subpopulations, patients with FLT3-ITD mutation and low levels of ALK have a response rate similar to upfront imatinib treatment. However, this observation should be confirmed in larger, prospective studies." - Anonymous Online Contributor

Unverified Answer

What are common treatments for leukemia?

"There is some evidence that various agents can be used to treat leukemia in combination with other agents, such as the chemotherapy drugs cyclophosphamide or fludarabine. In a lesser number of cases, the patients may need additional therapy with a bone marrow transplant. However, no consensus exists on which treatment should be given first, or combined with other drugs. The main problem for physicians is not whether they should use one agent or another, but how to select the most effective drug. For example, some treatment regimens can lead to remission – a state in which all symptoms have subsided. But after remission the disease relapses within weeks. This phenomenon has become known as "post-remission syndrome"." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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