E7777 for Lymphoma, Large B-Cell, Diffuse

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Minnesota, Masonic Cancer Center, Minneapolis, MN
Lymphoma, Large B-Cell, Diffuse+5 More
E7777 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called E7777 may help improve the effectiveness of a CAR-T cell therapy for lymphoma.

See full description

Eligible Conditions

  • Lymphoma, Large B-Cell, Diffuse
  • High Grade B-cell Lymphoma (HGBCL)
  • DLBCL Arising From Follicular Lymphoma
  • Diffuse Large B-Cell Lymphoma (DLBCL)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Lymphoma, Large B-Cell, Diffuse

Study Objectives

This trial is evaluating whether E7777 will improve 1 primary outcome and 6 secondary outcomes in patients with Lymphoma, Large B-Cell, Diffuse. Measurement will happen over the course of 28 Days Post E7777 infusion.

Year 1
Number of participants experiencing disease free survival (DFS)
Number of participants experiencing overall survival (OS)
Day 100
Number of non-relapse mortality incidents at day 100
Number of participants experiencing adverse events
Day 28
Number of Grade 3 or 4 cytokine release syndrome (CRS) incidents
Number of Grade 3 or 4 immune effector cell associated neurotoxicity (ICAN) syndrome incidents
Number of participants experiencing dose limiting toxicity events

Trial Safety

Safety Progress

1 of 3

Other trials for Lymphoma, Large B-Cell, Diffuse

Side Effects for

Other: E7777 9 mcg/kg/Day
Hyponatraemia
100%
Pyrexia
100%
Rash
100%
Lymphopenia
100%
C-reactive protein increased
100%
Decreased appetite
100%
Back pain
100%
Thrombocytopenia
100%
Diarrhoea
100%
Aspartate aminotransferase increased
100%
Gamma-glutamyltransferase increased
100%
Blood alkaline phosphatase increased
100%
Proteinuria
100%
Dehydration
0%
Hypokalaemia
0%
Hyperuricaemia
0%
Stomatitis
0%
Conjunctivitis
0%
Herpes virus infection
0%
Skin candida
0%
Puncture site pain
0%
Cytomegalovirus infection
0%
Arthralgia
0%
Rhabdomyolysis
0%
Hiccups
0%
Skin ulcer
0%
Nausea
0%
Ascites
0%
Vessel puncture site erythema
0%
Dizziness
0%
Oedema peripheral
0%
Cellulitis
0%
Enterocolitis infectious
0%
Peripheral sensory neuropathy
0%
Dermatosis
0%
Hot flush
0%
Drug hypersensitivity
0%
Blood creatinine increased
0%
Dyspepsia
0%
Lung infection
0%
Abdominal discomfort
0%
Skin infection
0%
Dyslipidaemia
0%
Headache
0%
Cytomegalovirus chorioretinitis
0%
Ventricular arrhythmia
0%
Nasopharyngitis
0%
Pneumonia
0%
Disorder of orbit
0%
Dry eye
0%
Blood lactate dehydrogenase increased
0%
Hepatic function abnormal
0%
Hyperglycaemia
0%
Genital candidiasis
0%
Alanine aminotransferase increased
0%
Musculoskeletal stiffness
0%
Pruritus
0%
Skin fissures
0%
Hypertension
0%
Toxic skin eruption
0%
Eczema eyelids
0%
Colitis
0%
Facial pain
0%
Prostatic pain
0%
Muscle spasms
0%
Dermal cyst
0%
Dermatitis contact
0%
Hypotension
0%
Vasculitis
0%
Contrast media allergy
0%
Cough
0%
Injection site erythema
0%
Altered state of consciousness
0%
Pain
0%
Neutropenia
0%
Lymphocytosis
0%
Angular cheilitis
0%
Photopsia
0%
Brain natriuretic peptide increased
0%
Impetigo
0%
Myalgia
0%
Blood urea increased
0%
Renal impairment
0%
Tumour pain
0%
Rash generalised
0%
Hypocalcaemia
0%
Insomnia
0%
Abdominal pain upper
0%
Gingivitis
0%
Fatigue
0%
Face oedema
0%
Oropharyngeal pain
0%
Skin erosion
0%
Generalised oedema
0%
Leukocytosis
0%
Constipation
0%
Folliculitis
0%
Gastroenteritis
0%
Parotitis
0%
Upper respiratory tract infection
0%
Tinea pedis
0%
Cytomegalovirus test positive
0%
N-terminal prohormone brain natriuretic peptide increased
0%
Hypertriglyceridaemia
0%
Hypophosphataemia
0%
Hyperkalaemia
0%
Tumour lysis syndrome
0%
Tumour associated fever
0%
Cancer pain
0%
Dysgeusia
0%
Post herpetic neuralgia
0%
Laryngeal pain
0%
Pharyngeal inflammation
0%
Capillary leak syndrome
0%
Leukopenia
0%
Eye pain
0%
Cardiomegaly
0%
Vomiting
0%
Conjunctivitis allergic
0%
Thrombocytosis
0%
Sinus tachycardia
0%
Hypoacusis
0%
Anaemia
0%
Adrenal insufficiency
0%
Hypothyroidism
0%
Sinus bradycardia
0%
Supraventricular extrasystoles
0%
Vision blurred
0%
Retinal exudates
0%
Herpes zoster
0%
Lymphadenopathy
0%
Laryngeal haemorrhage
0%
Squamous cell carcinoma of skin
0%
Drug eruption
0%
Mouth ulceration
0%
Dysphagia
0%
Blood cholesterol increased
0%
Gingival pain
0%
Perianal erythema
0%
Malaise
0%
Wound infection
0%
Wound
0%
Lipase increased
0%
Toothache
0%
Haemorrhoids
0%
Delirium
0%
Hallucination, auditory
0%
Weight increased
0%
Amylase increased
0%
Blood bilirubin increased
0%
Weight decreased
0%
Blood creatine phosphokinase increased
0%
Blood fibrinogen decreased
0%
Electrocardiogram QT prolonged
0%
Hypoalbuminaemia
0%
Upper respiratory tract inflammation
0%
Dermatitis exfoliative generalised
0%
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT02676778) in the Other: E7777 9 mcg/kg/Day ARM group. Side effects include: Hyponatraemia with 100%, Pyrexia with 100%, Rash with 100%, Lymphopenia with 100%, C-reactive protein increased with 100%.

Trial Design

4 Treatment Groups

Dose level 1 : E7777 at 5 mcg/kg
1 of 4
Dose level 1 : E7777 at 9 mcg/kg
1 of 4
MTD from phase 1
1 of 4
Dose level 1 : E7777 at 7 mcg/kg
1 of 4
Experimental Treatment

This trial requires 30 total participants across 4 different treatment groups

This trial involves 4 different treatments. E7777 is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Dose level 1 : E7777 at 5 mcg/kg
Drug
Single dose of E7777 given on Day -7 two days prior to the start of lymphodepleting chemotherapy
Dose level 1 : E7777 at 9 mcg/kg
Drug
Single dose of E7777 given on Day -7 two days prior to the start of lymphodepleting chemotherapy
MTD from phase 1
Drug
Single dose of E7777 (Maximum tolerated dose level identified in phase 1) given on Day -7 two days prior to the start of lymphodepleting chemotherapy
Dose level 1 : E7777 at 7 mcg/kg
Drug
Single dose of E7777 given on Day -7 two days prior to the start of lymphodepleting chemotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
E7777
2016
Completed Phase 2
~50

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year post e7777 infusion
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year post e7777 infusion for reporting.

Closest Location

University of Minnesota, Masonic Cancer Center - Minneapolis, MN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Lymphoma, Large B-Cell, Diffuse 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:
diffuse large B-cell lymphoma (DLBCL) not otherwise specified
high grade B-cell lymphoma
DLBCL arising from follicular lymphoma
refractory to last line of therapy
myc over expression >40% in any prior biopsy
≥2 sites of extranodal disease
Received two or more lines of systemic therapy
Has secured insurance coverage for Kymriah administration either in the outpatient or inpatient setting.
Age 18 years or older at the time of signing consent.
ECOG performance status of 0, 1, or 2

Patient Q&A Section

Can lymphoma be cured?

"The vast majority of cases of HL can be cured with chemotherapy, radiation or surgery alone. Staging factors such as stage, nodal involvement or presence of symptoms at the time of diagnosis have no effect on cure outcomes." - Anonymous Online Contributor

Unverified Answer

What causes lymphoma?

"The cause of lymphoma is not understood, but it is likely that genetics, a high-risk environment, and accumulation of somatic mutations contribute to this devastating cancer." - Anonymous Online Contributor

Unverified Answer

What is lymphoma?

"Lymphoma is a type of cancer that forms in lymph tissues. It is most commonly found in the kidneys and bones. There are several subtypes, the rarest being Waldenström's Macroglobulinemia." - Anonymous Online Contributor

Unverified Answer

What are common treatments for lymphoma?

"Lymphoma in the form of HL, NHL, and Hodgkin disease has a strong genetic component and responds well to radiation, chemotherapy, targeted agents, immunotherapy, and stem cell transplantation. Many patients are able to have a long-term remission of the cancer using these techniques." - Anonymous Online Contributor

Unverified Answer

How many people get lymphoma a year in the United States?

"Around 200,000 cancers of non-Hodgkin's lymphoma are detected a year in the United States. Non-Hodgkin lymphoma accounts for 9% of all cancer diagnoses in the United States. The five most common types of non-Hodgkin lymphoma include: large-cell lymphoma (23.6% of non-Hodgkin lymphoma cases), diffuse large B-cell lymphoma (9.4% of non-Hodgkin lymphoma cases), follicular lymphoma (6.7% of non-Hodgkin lymphoma cases), Burkitt's lymphoma (5." - Anonymous Online Contributor

Unverified Answer

What are the signs of lymphoma?

"A doctor’s diagnosis is correct in less than half to a third of the cases. The signs of lymphoma usually appear many months to years before diagnoses and are much milder when lymphoma is suspected. A good way to detect lymphoma before it has been diagnosed is to suspect it from the signs of the lymphoma itself. A major role for lymphoma prevention is obviously to reduce the development of lymphoma and its symptoms by ensuring the cancer-fighting immunity in the people is working as it should." - Anonymous Online Contributor

Unverified Answer

How serious can lymphoma be?

"The disease progresses at its own alarming speed. Treatment with chemotherapy and/or radiotherapy, if used, will prolong survival by at least several weeks. There is still a long way to go with treatments for lymphomas including chemotherapy, radiotherapy, immunotherapy, stem cell transplants and new approaches that target the tumor cells. It's very rare for lymphoma to be the only problem that a dog is being faced with. However, lymphocytes are the predominant type of cells at the site of tumor formation; consequently, a serious, progressive and fast problem that can spread through the body as the disease progresses is highly probable. And although a lymphocyte can live a long life, a lymphoma is just that." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving e7777?

"Our case showed that it can be successfully treated by chemotherapy which is very cost effective, but if the patient does not accept it, then it will be necessary to get his consent to be eligible for a clinical trial." - Anonymous Online Contributor

Unverified Answer

Is e7777 typically used in combination with any other treatments?

"The use of E7777 with chemotherapy for the treatment of relapsed/refractory Hodgkin's disease shows promising responses. Although more research in this field is needed, these preliminary data suggest this medication may also be of benefit in the treatment of relapsed/refractory non-Hodgkin's lymphoma." - Anonymous Online Contributor

Unverified Answer

Does lymphoma run in families?

"We suggest that patients with lymphoma should be advised to investigate any family members with a history of lymphoma, who also have characteristic immunophenotype or high risk genotypes." - Anonymous Online Contributor

Unverified Answer

What is the latest research for lymphoma?

"In the last few years, most clinicians and researchers in the United States have seen great advancements in non-Hodgkin’s lymphoma treatment, the use of chemoprevention, the use of non-invasive imaging techniques for diagnosis and the ability to define remission from the disease. At the same time, there is a general consensus that immunotherapy is the most effective treatment, given the increased number of newly defined types of lymphomas as well as the better understanding of the malignant process." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating lymphoma?

"There have been several major advances for treating lymphoma in last 2 decades. The ability to assess the tumorous disease precisely and to tailor the treatment to the specific disease type and individual patients, has allowed patients who would not have been eligible for conventional treatments to be offered treatment based on their individual pathophysiology. Also, the better understanding and the characterization of the tumour infiltrating cells have paved the way to new treatment strategies for lymphoma. The immunotherapy (also called immunochemotherapy) involves the stimulation of the patient’s immune system with tumour antigens or cytokines and has led to clinical responses in a subgroup of patients." - 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.
See if you qualify for this trial
Get access to this novel treatment for Lymphoma, Large B-Cell, Diffuse by sharing your contact details with the study coordinator.