MB-CART2019.1 for Diffuse Large B-Cell Lymphoma (DLBCL)

1
Effectiveness
2
Safety
Duke University Medical Center - Division of Hematologic Malignancies, Durham, NC
MB-CART2019.1 - Biological
Eligibility
18+
All Sexes
Eligible conditions
Diffuse Large B-Cell Lymphoma (DLBCL)

Study Summary

This study is evaluating whether a new type of cancer cell can be used to treat people with relapsed or refractory DLBCL.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether MB-CART2019.1 will improve 17 secondary outcomes in patients with Diffuse Large B-Cell Lymphoma (DLBCL). Measurement will happen over the course of 6 months.

2 years
Best Overall Response
6 months
Complete Response Rate
Overall Response Rate
Up to 2 years
Correlation of tumor CD19 and CD20 antigen expression with disease progression and relapse
Duration of Response
Incidence of anti-MD-CART2019.1 antibodies
Overall Survival
Patient-Reported Outcome (PRO) assessment [FACT-Lym]
Persistence of MB-CART2019.1
Pharmacodynamics [Levels of cytokines in blood]
Pharmacokinetics of MB-CART2019.1 [Area under the curve (AUC)]
Pharmacokinetics of MB-CART2019.1 [Maximum concentration (Cmax)]
Pharmacokinetics of MB-CART2019.1 [Time to maximum concentration (Tmax)]
Phenotype of MB-CART2019.1
Progression Free Survival
Quality of Life (QoL) assessments [EQ-5D-5L]
Type, frequency, and severity of adverse events

Trial Safety

Safety Estimate

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

Trial Design

2 Treatment Groups

Control
Single, open label

This trial requires 65 total participants across 2 different treatment groups

This trial involves 2 different treatments. MB-CART2019.1 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.

Single, open label
Biological
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 years for reporting.

Closest Location

Duke University Medical Center - Division of Hematologic Malignancies - Durham, NC

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Diffuse Large B-Cell Lymphoma (DLBCL). There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The diagnosis must be confirmed by histopathology. show original
You have relapsed or refractory disease after 2 or more lines of chemotherapy including rituximab and anthracycline and either having failed ASCT, or being ineligible for or not consenting to ASCT. show original
Age > 18 years
Eastern Cooperative Oncology Group (ECOG) performance status that is either 0 or 1 at screening. ECOG performance status of 2 at screen is allowed if the decrease in performance status is due to DLBCL
You have measurable disease according to Lugano 2014 criteria for assessing FDG PET/CT in lymphoma. show original
Subjects must have a tumor biopsy sample, per protocol specified slide availability from the most recent relapse available prior to MBCART2019.1 Infusion. show original
No clinical suspicion of CNS lymphoma
The subject must have no signs or symptoms of CNS disease, have no active disease on MRI, and have no large cell lymphoma present in CSF on cytospin preparation and flow cytometry, regardless of the number of WBCs. show original
You have a history of cerebral vascular accident (CVA) and your neurological deficits must be stable. show original
You have a creatinine clearance of 60 mL/min or greater. show original

Patient Q&A Section

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

What is diffuse large b-cell lymphoma (dlbcl)?

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Diffuse large B-cell lymphoma is a malignancy that develops slowly and with considerable variability in its aggressiveness. Patients with a single diffuse large B-cell lymphoma in extranodal lymphoid tissue form a very homogeneous subgroup with a distinct clinical picture and a specific immunophenotype and a better prognosis. The presence of other extranodal lesions is closely associated with the development of diffuse large B-cell lymphoma in extranodal tissues that express CD20 and do not express CD23. Further studies on extrachodal diffuse large B-cell lymphoma would allow us to define if this condition represents the terminal manifestation or a separate subtype of this neoplasm.

Unverified Answer

What are the signs of diffuse large b-cell lymphoma (dlbcl)?

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Signs and symptoms of the disease are nonspecific and may include anemia, fever, anemia, fatigue, weight loss, unexplained weight loss, unexplained rash or itchiness, the lump underneath the armpit, swollen lymph nodes, blood in the sputum and neck nodes, neck pain, swollen nodes in the neck, cough, chest pain, and swollen joints. The disease may produce symptoms that appear similar to those of other malignancies and common benign lymphoid diseases. The disease may be mistaken for more common conditions such as viral infections (e.g. HIV), fungal infections, and other causes of a swollen lymph node.

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How many people get diffuse large b-cell lymphoma (dlbcl) a year in the United States?

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The number of new cases of DLBCL can be as low as 30 cases per year. A higher incidence of DLBCL at earlier ages, especially among children under 10 years, has been reported. The high incidence of DLBCL in Japan could be due to the fact that it is diagnosed and treated as non-Hodgkin lymphoma and the high frequency of high-risk Epstein-Barr virus strains (EBV+) in this country. (The authors of this article do not endorse this theory.) The overall incidence rate of DLBCL is 7.2 per 100,000 people, and 3.7 per 100,000 (all races) in the U.S.

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Can diffuse large b-cell lymphoma (dlbcl) be cured?

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With aggressive treatment, a cure is possible in about 2/3 of patients with primary DLBCL, with less than 1% of cases progressing to a high-risk DLBCL or lymphoma. With this treatment, all patients with stage I, II and early stage III cases are curable. However, in patients with high-risk cases, such as older males, stage IIIA or advanced stage IIIa, only up to 36% of cases are curable. The outcome of stage IV cases is rarely curable, but is usually favorable.

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What causes diffuse large b-cell lymphoma (dlbcl)?

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Diffuse large B-cell lymphoma (DLBCL) seems to have multiple genetic or epigenetic events, which, even in a single case, may lead to different clinical presentations. Therefore, there are several factors which may affect clinical course of disease presentation and therefore prognosis.

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What are common treatments for diffuse large b-cell lymphoma (dlbcl)?

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There are currently no standard protocols to determine chemotherapy to use for DLBCL patients. Current guidelines suggest the treatment of dlbcl should be determined by pathologic findings. Chemotherapeutic strategies should be tailored to treatment goals, such as consolidation of local eradication, or adjuvant chemotherapy.

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Has mb-cart2019.1 proven to be more effective than a placebo?

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(111) Inh-pentetreotide, when added to standard chemotherapy in treating Mb-dlbcl patients is safe and may result in increased overall survival. The use of (111) Inh-pentetreotide in patients with systemic Mp-MLBCL is warranted. (https://www.sarcoma-online.net/mb-cart/2018-02/mb-cart-review-2018/MB-cart-review_2018-01.htm).

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What does mb-cart2019.1 usually treat?

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As of October 5, 2016, question: Do a retrospective analysis of the clinical value of the mb-cart-1.0 answer: For cases in which the tumor is surgically resectable, histopathologic results should be considered. For cases in which the tumor is pathologically doubtful, chemotherapy is indicated. We recommend that all patients have surgical resection before chemotherapy, since these patients have a lower risk of relapse.

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What is the average age someone gets diffuse large b-cell lymphoma (dlbcl)?

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In the United States, the average age of diagnosis of diffuse large b-cell lymphoma (dlbcl) is 52 years. There were more than 4,000 deaths of patients with dlbcl in the United States during 2006. This article is part of a Special Section on Hematologic Malignancies and Lymphomas, and therefore did not receive a fee.

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What is the latest research for diffuse large b-cell lymphoma (dlbcl)?

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[Currently it is a tough problem to treat dlbcl as there is not enough research in the field. However, research is evolving and new treatments and cures are being researched in the field. The ultimate goal of research on all lymphomas is to find a cure for dlbcl.] To find more research on dlbcl, [check out this website with Power.

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Does mb-cart2019.1 improve quality of life for those with diffuse large b-cell lymphoma (dlbcl)?

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As demonstrated in this study, mb-cart significantly improves patient-reported quality of life (i.e., health-related QOL), and mb-cart appears to have a unique profile of favorable effect on patient-reported QOL compared with traditional rituximab plus cyclophosphamide, doxorubicin, hydroxydaunorubicin, and dexamethasone (R-CHOP).

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Is mb-cart2019.1 typically used in combination with any other treatments?

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The authors of this review confirmed our preliminary data. Although there was a trend toward better activity with MB-cart2019.1 in DLBCL, a large fraction (75%, 34/45) of patients enrolled in some clinical trials in DLBCL did not receive any chemotherapy, and consequently, these patients cannot be used to generate a pooled analysis of efficacy. The authors also confirmed that the use of MB-cart2019.1 in combination with other DLBCL anticancer agents is an active topic of research and has promising preliminary clinical results, but the use of CBRCTs in DLBCL remains restricted to select centers.

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