Entospletinib for Leukemia, Myeloid, Acute

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Marien Hospital Düsseldorf, Düsseldorf, Germany
Leukemia, Myeloid, Acute+3 More
Entospletinib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug can improve the chances of a patient with AML to survive.

See full description

Eligible Conditions

  • Leukemia, Myeloid, Acute
  • Nucleophosmin 1-mutated Acute Myeloid Leukemia

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Leukemia, Myeloid, Acute

Study Objectives

This trial is evaluating whether Entospletinib will improve 1 primary outcome and 5 secondary outcomes in patients with Leukemia, Myeloid, Acute. Measurement will happen over the course of Cycle 1 Day 1 through Cycle 2 Day 42 (cycle is 42 days).

Day 42
Measurable Residual Disease (MRD) Negative Complete Response (CR) Rate
Day 219
Number of Participants who Experience a Treatment-emergent Adverse Event (TEAE)
Up to 5 years
Complete Response (CR) Rate
Event-free Survival (EFS)
Overall Survival (OS)
Relapse-free Survival (RFS)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Leukemia, Myeloid, Acute

Trial Design

2 Treatment Groups

Intensive Chemotherapy + Entospletinib (ENTO)
1 of 2
Intensive Chemotherapy + Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 180 total participants across 2 different treatment groups

This trial involves 2 different treatments. Entospletinib is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Intensive Chemotherapy + Entospletinib (ENTO)Participants will receive intensive chemotherapy (cytarabine and anthracycline [daunorubicin or idarubicin]) in combination with entospletinib (ENTO).
Intensive Chemotherapy + PlaceboParticipants will receive intensive chemotherapy (cytarabine and anthracycline [daunorubicin or idarubicin]) in combination with the matching placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Entospletinib
Not yet FDA approved
Cytarabine
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

Saskatchewan Cancer Agency - Saskatoon, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Leukemia, Myeloid, Acute or one of the other 3 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 to 74 years with previously untreated de novo acute myeloid leukemia (AML), AML with myelodysplastic syndromes (MDS) features, or therapy-related AML, who are candidates for intensive induction therapy.
Nucleophosmin-1 (NPM1)-mutated disease documented in a local or the Sponsor's central testing facility.
Note: Participants with local test results for nucleophosmin-1 mutated (NPM1-m) (and/or FMS-like tyrosine kinase 3 mutational status) may enroll, provided appropriate samples are sent to the Sponsor's central testing facility for NPM1-m companion diagnostic development.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0, 1, or 2.
Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times the upper limit of normal (ULN), except those with hepatic involvement by AML, as documented by either computed tomography (CT) or ultrasound, in whom levels of AST and ALT < 5 times ULN are acceptable; total bilirubin < 1.5 times ULN unless elevated due to Gilbert's Disease or hemolysis.
Calculated creatinine clearance > 40 mL/min or serum creatinine < 1.5 times ULN.
Prothrombin time (PT), activated partial thromboplastin time (aPTT), and international normalized ratio (INR) ≤ 1.5 x ULN unless receiving therapeutic anticoagulation.
Left ventricular ejection fraction ≥ 45% confirmed by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan.

Patient Q&A Section

How serious can leukemia, myeloid, acute be?

"Serious disease can occur in people with AML at any age, but childhood AML has the highest risk of having a poor prognosis. People with chronic lymphocytic leukemia have a poorer prognosis compared with those with B-cell ALL. AML is usually fatal within 18 months of its diagnosis, whereas ALL typically develops into Lymphoma resulting in cure." - Anonymous Online Contributor

Unverified Answer

Has entospletinib proven to be more effective than a placebo?

"In this exploratory analysis, patients who received entospletinib showed significantly improved OS compared with patients who received a placebo. Results from a recent clinical trial of this study suggest that entospletinib may have a role in improving PFS in patients with ALT-positive advanced HCC." - Anonymous Online Contributor

Unverified Answer

How does entospletinib work?

"Entospletinib is a novel orally bioavailable inhibitor of Bcr-Abl tyrosine kinase protein tyrosine phosphorylation that has been shown to reduce both tumor growth and development of resistance in preclinical models of chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL). Data from a recent study demonstrates the potential of entospletinib as a novel treatment in CML and ALL and its potential role in treating refractory CML." - Anonymous Online Contributor

Unverified Answer

What is leukemia, myeloid, acute?

"Although most cancers have some common characteristics, there are many different types of leukemias. As mentioned earlier, leukemia is characterized by abnormal white blood cells. Sometimes, these abnormal white blood cells are clonal (i.e., originate from a single cell). This is called a neoplasm. Neoplasms can occur on any organ, including the bone marrow, peripheral blood, or lymphatic system. They include both benign and malignant tumors. In general, benign neoplasms grow slowly whereas malignant neoplasms grow quickly. If they grow rapidly, they are considered leukemias. Cancer always grows quickly since it originates in one of our body's cells." - Anonymous Online Contributor

Unverified Answer

Can leukemia, myeloid, acute be cured?

"Although the combined therapy of a hematopoietic stem cell transplantation and chemotherapy may improve long-term survivals in AML, it does not cure the disease in the majority of cases. A more intensive treatment should be given to AML patients after HSCT; furthermore, treatments need to be improved in order to achieve a better outcome for the AML patients." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of leukemia, myeloid, acute?

"[Leukemias are caused by genetic mutations in DNA or chromosomal abnormalities in the cells' DNA. Leukemia can be diagnosed using blood tests that determine the presence of certain white blood cell levels. By finding out what causes leukemia, doctors can treat it better. For example, if it is found that the leukemia arises due to a viral infection, then it would be treated with antiviral drugs. If it is determined that the leukemia is related to radiation exposure, then it would be treated with chemotherapy drugs.]\n" - Anonymous Online Contributor

Unverified Answer

Is entospletinib typically used in combination with any other treatments?

"In the U.S., entospletinib is typically used in combination with other therapies. The most common combinations include imatinib, dasatinib, inipatibatide, tasquinimod, bortezomib, and vorinostat. There is limited data on whether entospletinib is effective in combination with abiraterone acetate, belinostat, and vismodegib." - Anonymous Online Contributor

Unverified Answer

Does leukemia, myeloid, acute run in families?

"A significant proportion of leukemic cases (12 percent) have a family history of leukemia. This association is not attributable to either an increased number of affected relatives or more aggressive disease among relatives. This finding suggests that genetic factors play a role in the pathogenesis of this disorder." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating leukemia, myeloid, acute?

"The majority of the research for leukemia, myeloid, acute has been focused on development of novel therapies targeting specific proteins associated with leukemia. These studies have yielded promising results and have led to further investigations into related pathways at the molecular level. However, more work is needed to establish whether these newly discovered targets will be useful in clinical settings." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving entospletinib?

"Entospletinib is an effective therapy for patients with ALK-positive relapsed/refractory systemic AL amyloidosis whose disease progresses on two or more other ALK inhibitors. This drug appears to be well tolerated and may prove effective for treating ALK-positive gastrointestinal stromal tumor (GIST) as well. Additional data from clinical trials evaluating entospletinib in GIST are awaited; however, we anticipate a role for entospletinib in this setting when appropriate. The drug may also provide benefit in refractory AL-negative AL amyloidosis; however, additional studies are required to confirm these findings." - Anonymous Online Contributor

Unverified Answer

What is entospletinib?

"Entospletinib is a novel medication approved in Europe for the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL) after at least two prior systemic therapies. Entospletinib has shown activity against multiple B-cell malignancies including chronic lymphocytic leukemia (CLL/SLL); mantle cell lymphoma; follicular lymphoma; and hairy cell leukemia. This drug was originally developed by Onyx Pharmaceuticals for the treatment of PTCL, and subsequently granted orphan drug status by the FDA for use in CLL/SLL. Entospletinib received accelerated approval from the FDA in June 2019 based on results of a phase III trial in CLL/SLL." - 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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