MAK683 for Lymphoma, Large B-Cell, Diffuse

Phase-Based Estimates
Novartis Investigative Site, Freiburg, Germany
Lymphoma, Large B-Cell, Diffuse+1 More
MAK683 - Drug
All Sexes
Eligible conditions
Lymphoma, Large B-Cell, Diffuse

Study Summary

This study is evaluating whether a drug may help treat cancer.

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Eligible Conditions

  • Lymphoma, Large B-Cell, Diffuse
  • Diffuse Large B-cell Lymphoma

Treatment Effectiveness

Study Objectives

This trial is evaluating whether MAK683 will improve 2 primary outcomes and 8 secondary outcomes in patients with Lymphoma, Large B-Cell, Diffuse. Measurement will happen over the course of up to day 15.

30 months
Area Under the Plasma Concentration (AUC) Time Curve of MAK683
Half-Life of MAK683
Peak Plasma Concentration (Cmax) of MAK683
up to 28 days
Incidence of dose limiting toxicities (DLTs)
up to 30 months
Best Overall Response (BOR)
Duration of overall response (DOR)
Overall Response Rate (ORR)
Progression-free survival (PFS)
Year 3
Safety and tolerability
up to day 15
H3K27 tri methylation level in PBMC

Trial Safety

Trial Design

2 Treatment Groups

Phase I - All

This trial requires 203 total participants across 2 different treatment groups

This trial involves 2 different treatments. MAK683 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 1 & 2 and have already been tested with other people.

Phase I - All
advanced stage (relapsed/refractory or recurrent/metastatic) malignancy limited to the following malignancies; DLBCL, nasopharyngeal carcinoma, gastric cancer, ovarian cancer, prostate cancer and sarcoma.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

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

Closest Location

University of Texas MD Anderson Cancer Center Dept of Onc - Houston, TX

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 the other condition listed above. There are 3 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 that has come back after treatment (relapsed) or that has not responded to treatment (refractory) is considered to have measurable disease if it can be detected by certain tests show original
People with advanced or recurrent/metastatic solid tumors, including nasopharyngeal carcinoma, castration-resistant prostate cancer, gastric cancer, ovarian clear cell carcinoma and sarcoma, may be eligible for this study show original
A measure of how well a tumor responds to treatment, the Eastern Cooperative Oncology Group (ECOG) scale runs from 0 to 2 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.

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

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The incidence of diffuse large-cell lymphoma in the United States is approximately 10 cases per 100,000 or more. It also varies across racial/ethnic groups. In the United States, lymphoma, large-cell, diffuse accounts for approximately 5% of all lymphomas. Around 15-20% of cases are not in individuals who are younger than 40 years at diagnosis, and about 75% of cases appear to have an adverse prognosis.

Unverified Answer

What are the signs of lymphoma, large b-cell, diffuse?

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LCLD has a variable clinical picture. Initial signs of the disease may include fever, night sweats, weight loss, malaise and adenopathy. Other common signs include headache, night sweats, malaise, and weight loss. The diagnosis can be made on clinical grounds (e.g. lymphadenopathy) by correlating them with the blood test data. The diagnosis can also be made by pathological examination of tissue slides. Patients with LCLD have a high incidence of complications. Treatment of the complication is crucial; usually necessitating surgery. Early disease may be mistaken for LCLD; staging and investigation thus have to be done early.

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Can lymphoma, large b-cell, diffuse be cured?

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Despite advances in treatment, large B-cell, diffuse lymphomas may not be curable. For patients whose disease progresses after initial treatment response, no chemotherapy regimen has been shown to be superior to others, though newer chemotherapy regimens may be needed for treatment resistant disease.

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What are common treatments for lymphoma, large b-cell, diffuse?

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Lymphoma patients tend to receive a combination of immuno- and chemotherapeutic agents before and during radiation therapy. Chemotherapy and radiotherapy used in the treatment of patients with diffuse large B-cell lymphoma tend to involve the same chemotherapy agents as used against Hodgkin disease (HL).

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What causes lymphoma, large b-cell, diffuse?

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Lymphoma, large b-cell, diffuse is not fully understood, but is thought to be caused by infection with human T-cell leukemia virus type 1 (HTLV-I) and Epstein-Barr virus (EBV), or by some defect in cell-mediated immunity to these agents. These include a lack of B cells, which produce IL-4, a growth factor that promotes the survival of CD4+ T cells and inhibits multiplication and survival of B cells.

Unverified Answer

What is lymphoma, large b-cell, diffuse?

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LBCD is a newly described subtype of diffuse large B-cell lymphoma that is characterized by a distinct clinical spectrum when compared with other B-cell lymphomas, typically presenting as a younger age group than other subtypes of DLBCLs.

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What is the average age someone gets lymphoma, large b-cell, diffuse?

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On average, lymphoma, large b-cell, diffuse is diagnosed in 70 years old women. There is no differences between all geographic regions, age and stage. If you are looking to join a lymphoma clinical trial, Power can help you search recent trials by condition, treatment, or location.

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How quickly does lymphoma, large b-cell, diffuse spread?

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Lymphoma, large-b-cell, diffuse spreads mostly within 2 years. Most patients with lymphoma, large-b-cell, diffuse survive at least three years. A large lymphoma registry database is required to more consistently assess patterns of care.

Unverified Answer

What are the latest developments in mak683 for therapeutic use?

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Results from a recent paper highlights the importance of pharmacokinetic/pharmacodynamic modeling in the development of optimal dosing for novel biotherapeutics. Results from a recent paper indicate that the development of therapeutic dosing regimens of mak683 is more challenging than anticipated and may require the establishment of a dosing regimen other than the current schedule.

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What are the common side effects of mak683?

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In a recent study, findings, the most frequent (≥4%) adverse events reported in patients given mak683 were fatigue, decreased appetite, and diarrhea. All of these events were mild or moderate in severity and did not preclude the completion of treatment. Considering clinical practice and the low rate or severity of these AEs relative to the frequency and severity of other adverse effects observed in patients treated with mak683, it is unlikely that they adversely affect mak683 overall benefit, although further research will be necessary to confirm this.

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What is the latest research for lymphoma, large b-cell, diffuse?

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There is only one clinical trial for patients with lymphoma, large b-cell, diffuse and the latest research was published in June 1998, meaning [there have been (not) many studies over the last three or so years that support or refute the clinical trial findings of this particular study]. There were no positive trials found that indicated that chemotherapy could improve survival with chemotherapy, so [there is] only one study that deals with patient treatment with large-b-cell lymphoma, diffuse, so it will be difficult to determine the current state of the research for lymphoma, large b-cell, diffuse.

Unverified Answer
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