E7820 for Leukemia

No longer recruiting at 8 trial locations

Overseen By Eytan Stein, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Sulfa medications

Disqualifiers: Acute promyelocytic leukemia, Cardiac disease, Active infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the drug E7820 can effectively treat certain blood cancers, such as acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), and chronic myelomonocytic leukemia (CMML). It targets patients whose cancer has returned or has not responded to treatment and who have specific gene mutations related to their cancer. Ideal candidates for this trial are those diagnosed with relapsed or refractory AML, MDS, or CMML with specific genetic mutations, who have not found success with other treatments. Participants will take E7820 daily, starting at a 100 mg dose, with adjustments made if necessary. As a Phase 2 trial, this research measures how well E7820 works in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that E7820 is likely to be safe for humans?

Research has shown that E7820 is generally safe. Previous studies found that most people can take E7820 without serious side effects when used alone. However, some side effects might still occur, and the dose may be lowered if necessary. Discussing any potential risks with the medical team before joining a trial is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

E7820 is unique because it specifically targets angiogenesis, the process of new blood vessel formation, which is crucial for cancer cell growth and survival. Unlike standard treatments for leukemia, such as chemotherapy and targeted therapies like tyrosine kinase inhibitors, E7820 works by inhibiting the formation of blood vessels that supply the cancer cells, potentially starving them of nutrients. Researchers are excited about E7820 because its novel mechanism of action might offer a new way to combat leukemia, especially for patients who have not responded well to existing therapies. Additionally, the ability to adjust the dosage based on toxicity levels may help minimize side effects, improving patient comfort during treatment.

What evidence suggests that E7820 might be an effective treatment for leukemia?

Research has shown that E7820, the investigational treatment in this trial, could help treat certain blood cancers with specific gene mutations. Studies have found that E7820 can break down a protein called RBM39, linked to these cancers. Early results suggest this might aid in fighting acute myeloid leukemia (AML) and similar diseases. E7820 may also be more effective when combined with other treatments like venetoclax, which has benefited some patients with these mutations. Overall, while more research is needed, the initial findings are promising for those with relapsed or difficult-to-treat blood cancers. ^{2 3 4 6 7}

Who Is on the Research Team?

Eytan Stein, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Adults with relapsed or refractory myeloid cancers, specifically AML, MDS, or CMML that have certain splicing factor gene mutations. They must have tried specific treatments without success and should not be pregnant or breastfeeding. Participants need to be in a stable enough condition to follow the study schedule.

Inclusion Criteria

My CMML did not improve after specific treatments.

My CMML cancer has returned after initially responding to treatment.

My blood cancer has returned or didn't respond to treatment, and I have a specific genetic mutation.

Exclusion Criteria

My heart's electrical activity is irregular or I have a family history of similar issues.

I haven't had serious heart issues like heart failure, heart attack, or stroke in the last 6 months.

I am currently pregnant or breastfeeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily administration of E7820, starting at 100 mg daily, with dose adjustments for toxicity

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• E7820

Trial Overview The trial is testing E7820's effectiveness for those with myeloid cancers who've had previous treatment failures. It focuses on patients whose cancer has returned after remission or hasn't responded to standard therapies.

How Is the Trial Designed?

Group I: E7820 Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Eisai Inc.

Industry Sponsor

Trials

524

Recruited

161,000+

Founded

Eisai Inc. was established in 1995 as the U.S. subsidiary of Eisai Co., Ltd.

Headquarters

Woodcliff Lake, NJ, USA

Known For

Neurology and Oncology

Top Products

Aricept (donepezil), Lenvima (lenvatinib), Leqembi (lecanemab), Halaven (eribulin)

Lynn Kramer

Eisai Inc.

Chief Medical Officer since 2019

MD

Tatsuyuki Yasuno

Eisai Inc.

Chief Executive Officer since 2023

MBA from Kellogg School of Management, Northwestern University; Bachelor of Political Science from Waseda University

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10681888/

E7820, an anti-cancer sulfonamide, degrades RBM39 in ... E7820, an anti-cancer sulfonamide, degrades RBM39 in patients with splicing factor mutant myeloid malignancies: a phase II clinical trial

2. ashpublications.org ashpublications.org/blood/article/142/Supplement%201/1547/502450/E7820-an-Anti-Cancer-Sulfonamide-in-Combination

E7820, an Anti-Cancer Sulfonamide, in Combination with ... Recent clinical data show that treatment with venetoclax can overcome the negative prognostic impact of splicing factor mutations in AML ( ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0006497123081508

E7820, an Anti-Cancer Sulfonamide, in Combination with ... Recent clinical data show that treatment with venetoclax can overcome the negative prognostic impact of splicing factor mutations in AML ( ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05024994?intr=E7820&aggFilters=studyType:int&viewType=Table&rank=2

A Study of E7820 in People With Bone Marrow (Myeloid) ... The researchers are doing this study to find out whether E7820 is an effective treatment for people with relapsed/refractory myeloid cancers with mutations ...

5. researchgate.net researchgate.net/journal/Leukemia-1476-5551/publication/374555792_E7820_an_anti-cancer_sulfonamide_degrades_RBM39_in_patients_with_splicing_factor_mutant_myeloid_malignancies_a_phase_II_clinical_trial/links/6524bb74d717ef1293de9103/E7820-an-anti-cancer-sulfonamide-degrades-RBM39-in-patients-with-splicing-factor-mutant-myeloid-malignancies-a-phase-II-clinical-trial.pdf?origin=scientificContributions

E7820, an anti-cancer sulfonamide, degrades RBM39 in ... Given prior preclinical data demonstrating that RBM39 degradation may enhance the activity of venetoclax in myeloid malignancies [15] as well as ...

6. nature.com nature.com/articles/s41375-023-02050-4

E7820, an anti-cancer sulfonamide, degrades RBM39 in ... The safety profile of E7820 monotherapy was consistent with previously reported data [9]. Equally important, we provide the first evidence ...

7. eisai.com eisai.com/news/2024/news202465.html

Investigator-initiated clinical studies ... The results showed that the administration of E7820 at 100 mg/kg led to tumor shrinkage in 16 of the 42 models (38.1%), including 7 of the 12 ...