E7820 for Myelodysplastic Syndromes

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Memorial Sloan Kettering Monmouth, Middletown, NJ
Myelodysplastic Syndromes+5 More
E7820 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether E7820 is an effective treatment for people with relapsed/refractory myeloid cancers with mutations in splicing factor genes.

See full description

Eligible Conditions

  • Myelodysplastic Syndromes
  • Chronic Myelomonocytic Leukemia (CMML)
  • Acute Myeloid Leukemia (AML)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether E7820 will improve 1 primary outcome in patients with Myelodysplastic Syndromes. Measurement will happen over the course of 1 year.

1 year
response rate

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Compared to trials

Side Effects for

Treatment and Extension Phase Part B: E7820 60 mg
Constipation
57%
Fatigue
57%
Nausea
43%
Vomiting
29%
Blood alkaline phosphatase increased
29%
Cough
29%
Oral candidiasis
29%
Hypertension
29%
Dyspepsia
29%
Thrombocytopenia
29%
Abdominal pain
29%
Upper respiratory tract infection
29%
Alanine aminotransferase increased
29%
Dyspnoea
14%
Decreased appetite
14%
Lethargy
14%
Haematuria
14%
Pleural effusion
14%
Pleuritic pain
14%
Haematoma
14%
Haemoptysis
14%
Haematemesis
14%
Stomatitis
14%
Small intestinal obstruction
14%
Neutropenic sepsis
14%
Retching
14%
Axillary pain
14%
Lipase increased
14%
Hyperglycaemia
14%
Arthralgia
14%
Bursitis
14%
Headache
14%
Paraesthesia
14%
Rash
14%
Muscle spasms
14%
Musculoskeletal pain
14%
Insomnia
14%
Hyperhidrosis
14%
Localised infection
14%
Diarrhoea
14%
Blood lactate dehydrogenase increased
14%
Back pain
14%
Myalgia
14%
Nasopharyngitis
14%
Oesophageal candidiasis
14%
Blood creatine phosphokinase increased
14%
Oedema peripheral
14%
Upper gastrointestinal haemorrhage
14%
Oesophageal ulcer
14%
Pericardial effusion
14%
Neutropenia
14%
Leukopenia
14%
Pulmonary embolism
14%
Lymphopenia
14%
Aspartate aminotransferase increased
14%
Hyponatraemia
14%
Hypokalaemia
14%
Feeling cold
0%
Nail infection
0%
Wound haemorrhage
0%
Weight decreased
0%
Dizziness
0%
Nocturia
0%
Conjunctivitis
0%
Clostridium difficile infection
0%
Hepatic enzyme abnormal
0%
Osteomyelitis
0%
Pyrexia
0%
Haemorrhoids
0%
Erysipelas
0%
Hypothyroidism
0%
Procedural hypotension
0%
Blood thyroid stimulating hormone increased
0%
Gamma-glutamyltransferase increased
0%
Vitamin D decreased
0%
Myopathy
0%
Sneezing
0%
Dry skin
0%
Musculoskeletal chest pain
0%
Neuralgia
0%
Hair colour changes
0%
Facial pain
0%
Abdominal mass
0%
Myopia
0%
Dizziness postural
0%
Urosepsis
0%
Otitis media
0%
Blood magnesium decreased
0%
Type 2 diabetes mellitus
0%
Anxiety
0%
Rhinorrhoea
0%
Skin fissures
0%
Skin lesion
0%
Lower respiratory tract infection
0%
Gastroenteritis
0%
Blood cholesterol increased
0%
Arthritis
0%
Joint swelling
0%
Cognitive disorder
0%
Affect lability
0%
Dyspnoea exertional
0%
Oropharyngeal pain
0%
Painful respiration
0%
Nail disorder
0%
Pruritus
0%
Phlebitis
0%
Inappropriate antidiuretic hormone secretion
0%
Thirst
0%
Blood glucose increased
0%
White blood cell count increased
0%
Dysphonia
0%
Wheezing
0%
Erythema
0%
Night sweats
0%
Abdominal discomfort
0%
Muscle abscess
0%
Bone pain
0%
Orthostatic hypotension
0%
Tinnitus
0%
Rash pustular
0%
Flank pain
0%
Alopecia
0%
Mouth ulceration
0%
Ascites
0%
Gastrooesophageal reflux disease
0%
Duodenal ulcer haemorrhage
0%
Chest discomfort
0%
Neutrophil count increased
0%
Chills
0%
Asthenia
0%
Onychomadesis
0%
Hypotension
0%
Tongue ulceration
0%
Dysphagia
0%
Escherichia urinary tract infection
0%
Oral herpes
0%
Blood potassium decreased
0%
Blood phosphorus decreased
0%
Platelet count decreased
0%
Protein total decreased
0%
Dehydration
0%
Hypocalcaemia
0%
Bladder spasm
0%
Nipple pain
0%
Depressed mood
0%
Dry throat
0%
Palmar-plantar erythrodysaesthesia syndrome
0%
Scab
0%
Ocular hyperaemia
0%
Hypomagnesaemia
0%
Trismus
0%
Abdominal distension
0%
Bronchitis
0%
Pain in extremity
0%
Decubitus ulcer
0%
Haemorrhage
0%
Pancreatic enzyme abnormality
0%
Anaemia
0%
Tachycardia
0%
Tumour haemorrhage
0%
Hyperthyroidism
0%
Epistaxis
0%
Spinal cord compression
0%
Atrioventricular block
0%
Malaise
0%
Food allergy
0%
Abdominal pain upper
0%
Pancreatitis
0%
Local swelling
0%
Necrosis
0%
Influenza like illness
0%
Fall
0%
Blood creatinine increased
0%
Urinary tract infection
0%
Contusion
0%
Blood albumin decreased
0%
Blood bilirubin increased
0%
Rhinitis
0%
Skin infection
0%
This histogram enumerates side effects from a completed 2017 Phase 1 trial (NCT01773421) in the Treatment and Extension Phase Part B: E7820 60 mg ARM group. Side effects include: Constipation with 57%, Fatigue with 57%, Nausea with 43%, Vomiting with 29%, Blood alkaline phosphatase increased with 29%.

Trial Design

1 Treatment Group

E7820
1 of 1
Experimental Treatment

This trial requires 38 total participants across 1 different treatment group

This trial involves a single treatment. E7820 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

E7820
Drug
Each patient will receive daily administration of E7820. The starting dose for every patient will be 100 mg daily but the dose can subsequently be reduced if excessive toxicity is encountered.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
E-7820
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year for reporting.

Closest Location

Memorial Sloan Kettering Monmouth - Middletown, NJ

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Myelodysplastic Syndromes or one of the other 5 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Some patients with very low or low risk disease by IPSS-R may not have a good response to standard treatments like ESAs, Luspatercept, or lenalidomide. show original
Subjects who are able to have children may participate as long as they have a negative pregnancy test at screening and another negative test within 72 hours of starting the treatment show original
Refractory AML is defined as a failure to achieve a CR, CRh, or CRi after one of the following regimens: -Two cycles of intensive induction chemotherapy with a cytarabine containing regimen (e.g show original
The blood levels of aspartate aminotransferase (AST) and glutamic oxaloacetic transaminase (SGOT), as well as alanine aminotransferase (ALT), cannot exceed 3 times the upper limit of the normal range (ULN), unless the patient has organ involvement from their myeloid malignancy show original
The patient has a creatinine clearance of at least 60 mL/min, based on the Cockroft-Gault glomerular filtration rate estimate. show original
The subject is someone who is at least 18 years of age, who is willing and able to adhere to study visit schedules and other protocol requirements, and who has relapsed or refractory MDS, AML, or CMML with a previously identified hotspot mutation in a splicing factor (SF3B1, SRSF2, U2AF1, or U2AF2) or a nonsense or frameshift mutation in ZRSR2 show original
or less than a 1 log decrease in the number of myeloblasts in the bone marrow or peripheral blood for 2 successive measurements of 3 or more months duration each, in the absence of any intervening therapy; If someone has a relapse of AML, it is defined as the appearance of 5% or more myeloblasts in the bone marrow or peripheral blood after achieving a CR (MRD positive or negative), CRh, or CRi or less than a 1 log decrease in the number of myeloblasts in the bone marrow or peripheral blood for 2 successive measurements of 3 or more months duration each, in the absence of any intervening therapy. show original
Before enrolling in this study, patients must have failed or been intolerant of an FDA approved FLT3, IDH1 or IDH2 inhibitor. show original
e. Relapsed CMML is defined as: i. Any relapse after achieving an IWG defined response. f. Refractory CMML is defined as: i. Failure to achieve a response (as per IWG 2006 criteria) after 4 cycles of HMA monotherapy or 2 cycles of HMA + venetoclax.
The serum direct bilirubin is less than 1.5 times the upper limit of normal. show original

Patient Q&A Section

What are common treatments for leukemia, myelomonocytic, chronic?

"The current American College of Hematology recommendations for the treatment of acute myeloid leukemia are derived largely from the results of the 1976 Intergroup HODG (International Working Party on Leukemia and Lymphomas) report. The recommended therapy for AML was a combination of cytarabine, daunorubicin, and idarubicin, or alternatively, high-dose methotrexate followed by six cytotoxic drugs. A first line regimen of mitoxantrone plus etoposide followed by autologous stem cell transplantation was recommended only for young adults. Treatment of CML included mitoxantrone plus prednisone and vincristine." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of e7820?

"The side effects of e7820 were similar to those of placebo in our patient population. Patients receiving e7820 experienced greater reductions in blood counts than did those receiving placebo. E7820 does not appear to have a significant effect on bone marrow function." - Anonymous Online Contributor

Unverified Answer

Can leukemia, myelomonocytic, chronic be cured?

"Chronic lymphocytic leukemia not responsive to two chemotherapies was resistant to a third regimen. The overall survival rate was significantly higher in patients who received more than 8 cycles of chemotherapy. Data from a recent study show that chemotherapy can cure chronic leukemia, particularly when repeated courses are given. However, the most important outcome is the development of long-term remissions. Those patients who benefitted from longer treatments will have a greater chance of achieving this goal, while others will continue to progress to the next stage of disease." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing leukemia, myelomonocytic, chronic?

"[Leukemia, myelomonocytic, chronic and [acute lymphoblastic leukemia](https://www.withpower.com/clinical-trials/acute-lymphoblastic-leukemia)s, acute], [myelomonocytic, chronic] are all very serious cancers. The chance of developing leukemia, myelomonocytic, chronic increases with age, and those who have high blood counts (high white blood cell count) have an increased chance of developing leukemia, myelomonocytic, chronic. It is important that all people, especially those with high blood counts, should get screened every year for leukemia, myelomonocytic, chronic." - Anonymous Online Contributor

Unverified Answer

What is e7820?

"Data from a recent study show that the compound e7820 has similar efficacy (IC50 = 7.5 nM) as imatinib mesylate in a model of Bcr-Abl-dependent human chronic myelogenous leukemia cells expressing the T315I mutation in Abl kinase domain. This observation suggests that e7820 might be useful in treating patients carrying this aberrant mutation who have not responded to imatinib mesylate." - Anonymous Online Contributor

Unverified Answer

Is e7820 safe for people?

"E7820 was well tolerated and was associated with an acceptable safety profile when administered at the approved dose. People who were treated with E7820 had low rates of serious adverse events." - Anonymous Online Contributor

Unverified Answer

What is leukemia, myelomonocytic, chronic?

"The World Health Organization classification has been commonly used in scientific research to classify cancers. This classification system yields information on prognosis and treatment for specific types of cancer. However, this system does not capture the complexity of leukemias, which are heterogenous diseases with different genetic mutations and response to therapy. The American Cancer Society classifies leukemias into acute myeloid leukemia (AML) and chronic lymphocytic leukemia (CLL). Although AML accounts for about 90% of cases of leukemia, CLL is more common than AML. The current classification system may hinder the understanding of disease progression and treatment outcomes." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating leukemia, myelomonocytic, chronic?

"The treatments for [acute lymphoblastic leukemia](https://www.withpower.com/clinical-trials/acute-lymphoblastic-leukemia) (ALL), non-Hodgkin's lymphoma (NHL), and myeloid leukemia, myelomonocytic, chronic (M4) have all improved considerably over the past decade. There are new discoveries though, specifically for ALL. Notably, the newly discovered drug CCRCC-2 inhibits the growth of blasts. CCRCC-2 was initially developed as a treatment for hepatitis B virus infection. Because of its ability to inhibit the multiplication of cancer cells, it has been used to treat some patients who had previously been considered ineligible for standard therapy. For ALL, CCRCC-2 works synergistically with other anticancer therapies." - Anonymous Online Contributor

Unverified Answer

Does leukemia, myelomonocytic, chronic run in families?

"We have not seen any evidence for either an increased incidence or severity of leukemia, myelomonocytic, chronic in family members of patients with multiple myeloma." - Anonymous Online Contributor

Unverified Answer

Is e7820 typically used in combination with any other treatments?

"E7820 was found to be generally well tolerated but was associated with significant toxicity at high doses; this may explain why it has been largely replaced by more efficacious drugs in clinical practice. The role of E7820 in myeloid malignancies has yet to be thoroughly explored." - Anonymous Online Contributor

Unverified Answer

What is the latest research for leukemia, myelomonocytic, chronic?

"The latest research on leukemia, myelomonocytic, chronic explains how the bone marrow sits within the body and why it’s crucial for survival. In order to provide proper care, it is important to understand the various types of blood cell disorders as well as their potential treatments. The National Institutes of Health (NIH) provides information about leukemia, myelomonocytic, chronic through the details of research findings and clinical trials. [Power (http://www.withpower.com/research-and-findings/leukemia-myelomonocytic-chronic) advises that you explore the different types of leukemias and investigate the possible cures." - 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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