Brentuximab Vedotin for Immunoblastic Lymphadenopathy

1
Effectiveness
2
Safety
Northwestern University, Chicago, IL
Immunoblastic Lymphadenopathy+20 More
Brentuximab Vedotin - Drug
Eligibility
18+
All Sexes
Eligible conditions
Immunoblastic Lymphadenopathy

Study Summary

This study is evaluating whether a combination of two drugs may be more effective than one drug alone in treating patients with recurrent peripheral T-cell lymphoma.

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Eligible Conditions

  • Immunoblastic Lymphadenopathy
  • Lymphoma, T-Cell, Peripheral
  • Enteropathy-Associated T-Cell Lymphoma
  • Lymphoma, T-Cell
  • Intestinal Diseases
  • Panniculitis
  • Lymphoma
  • Recurrent Peripheral T-Cell Lymphoma, Not Otherwise Specified
  • Recurrent Follicular T-Cell Lymphoma
  • Refractory Angioimmunoblastic T-Cell Lymphoma
  • Refractory Enteropathy-Associated T-Cell Lymphoma
  • Refractory Follicular T-Cell Lymphoma
  • Refractory Hepatosplenic T-Cell Lymphoma
  • Recurrent Hepatosplenic T-Cell Lymphoma
  • Refractory Nodal Peripheral T-Cell Lymphoma With TFH Phenotype
  • Recurrent Subcutaneous Panniculitis-Like T-Cell Lymphoma
  • Recurrent Enteropathy-Associated T-Cell Lymphoma
  • Recurrent Nodal Peripheral T-Cell Lymphoma With TFH Phenotype
  • Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified
  • Refractory Subcutaneous Panniculitis-Like T-Cell Lymphoma
  • Recurrent Angioimmunoblastic T-Cell Lymphoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Brentuximab Vedotin will improve 1 primary outcome and 5 secondary outcomes in patients with Immunoblastic Lymphadenopathy. Measurement will happen over the course of 30 days after end of treatment.

Day 30
Incidence of adverse events
Up to 5 years
Duration of objective response (DOR)
Overall objective response rate (ORR)
Overall survival
Progression free survival (PFS)
Time to response (TTR)

Trial Safety

Safety Estimate

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

Trial Design

2 Treatment Groups

Control
Treatment (brentuximab vedotin, pembrolizumab)

This trial requires 40 total participants across 2 different treatment groups

This trial involves 2 different treatments. Brentuximab Vedotin 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.

Treatment (brentuximab vedotin, pembrolizumab)Patients receive brentuximab vedotin IV over 30 minutes on day 1, and pembrolizumab IV over 30 minutes on day 3 of cycle 1, day 1 of subsequent cycles. Treatment repeats every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. After 6 cycles of treatment, patients may discontinue treatment if they experience disease progression, are eligible for stem cell transplant, or if they elect to not undergo SCT.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brentuximab vedotin
FDA approved
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 5 years for reporting.

Closest Location

Northwestern University - Chicago, IL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Immunoblastic Lymphadenopathy or one of the other 20 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:
AITL is a type of lymphoma that affects the immune system. show original
A T-cell lymphoma associated with enteropathy. show original
ENKTL: Extranodal Natural Killer/T-cell Lymphoma
You have follicular T-cell lymphoma. show original
This is a rare subtype of peripheral T-cell lymphoma. show original
A type of lymphoma characterized by a mass of lymphocytes in the subcutaneous tissue. show original
ALCL: Anaplastic Large Cell Lymphoma NOTE: CD30-positivity is defined as >= 1% of cells expressing CD30 as detected by immunohistochemistry (IHC) and determined by local review.
Disease that relapsed within > 6 months after completion of frontline therapy; or Disease that relapsed within any time after completion of secondary/subsequent lines of therapy; or Disease that was refractory to secondary/subsequent lines of therapy NOTE: Patients who have primary relapsed/refractory disease with relapse within 6 months of frontline treatment are not eligible. See exclusion criterion below NOTE: Exclusions on receipt of prior brentuximab vedotin are described in exclusion criterion below. Exclusions on receipt of prior immunotherapy are described in exclusion criterion below.
You have Hepatosplenic T-cell lymphoma. show original
A tumor of the peripheral lymphoid system that does not fit into any of the other categories. 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 are common treatments for immunoblastic lymphadenopathy?

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For patients with immunoblastic lymphadenopathy, our experience with many standard medication has shown that most individuals require steroids, either alone or in combination with other medications. We believe that, in those cases in which corticosteroids do not provide good results, it is prudent to consider treatment with cytotoxic medications. In the vast majority of cases in which these medications can be used clinically, they tend to provide excellent results. The use of cytotoxic medications, when possible, will produce excellent long-term results.

Unverified Answer

What is immunoblastic lymphadenopathy?

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IDL is a disorder that is marked by unexplained lymphadenopathy and low-grade fever accompanied by high production of IgM antibodies. IDL is a very rare disorder in Western countries but is relatively common in Asian countries.

Unverified Answer

How many people get immunoblastic lymphadenopathy a year in the United States?

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The incidence of immunoblastic lymphadenopathy was estimated at 1.5 people per 100,000 per year in this study.\nHowever, the incidence of immunoblastic lymphadenopathy may be higher, because the study included only 3 hospitals and the number of patients and procedures may have been underestimated.\nTherefore, the actual incidence we calculated was probably higher, i.e., 1.5/100,000. This calculation could be made by using Medicare beneficiaries aged>or= 50 years. \nIt is possible that a number of individuals other than those examined by this study experienced an immunoblastic lymphadenopathy.

Unverified Answer

Can immunoblastic lymphadenopathy be cured?

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Our case suggests that patients with immunoblastic lymphadenopathy may be cured or the condition resolved following aggressive therapy. More extensive studies are needed to confirm these findings on immunoblastic lymphadenopathy.

Unverified Answer

What causes immunoblastic lymphadenopathy?

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The ILD is considered an immunoregulatory syndrome characterized by the production of autoantibodies specifically directed against cells of B-cell lineage. The pathogenesis of ILD is still a subject of investigation and research. There are a number of drugs which influence immunological and immunochemical changes. There is no evidence, however, in support of the theory that certain drugs, either in a specific form or in a combination with other substances, cause the development of ILD. Further investigations, both in vivo and in vitro, are warranted to establish the full pathogenic mechanism. Since the development of ILD usually follows immunoglobulin light chain malignancies, it is also advisable to investigate patients who develop ILD.

Unverified Answer

What are the signs of immunoblastic lymphadenopathy?

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While it is considered a rare neoplasm, it should be distinguished from other B-cell proliferative disorders such as lymphoma, reactive lymphadenopathy, follicular dendritic cell-associated lymphadenopathy, and reactive nodular hyperplasia. These lesions frequently show an inverted immunophenotype to that seen in the neoplastic B cells from mantle cell lymphoma and primary peripheral B-cell lymphoma, and are difficult to distinguish, making diagnostic uncertainty commonplace. Clinical presentation, histologic features, and immunophenotype should be a good guide in making the correct diagnosis. Biopsy remains the best available technique for definitive diagnosis.

Unverified Answer

How does brentuximab vedotin work?

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BVV shows promise as both a single-agent and combination therapy in relapsed or refractory Hodgkin lymphoma. The clinical activity of BVV in FL and mantle cell lymphoma is very limited. The optimal dosing schedule and method of administering BVV and any combination treatment options have yet to be defined, so further clinical research is urgently awaited.

Unverified Answer

What does brentuximab vedotin usually treat?

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Brentuximab vedotin is being used cautiously to treat only a minority of patients with rituximab-refractory Hodgkin lymphoma and rituximab/brentuximab-refractory marginal zone lymphoma. The indications for treatment with brentuximab vedotin should be discussed with patients and caregivers.

Unverified Answer

How quickly does immunoblastic lymphadenopathy spread?

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The median interval of the lesions found in the lymph nodes in patients with AIL are between 2.5 and 9 months, regardless of clinical status or histological type. Results from a recent clinical trial suggest that this symptom may be present for an extended period time. Clinicians should remain alert of this possibility and ask the patients with a suspicious finding to come to the laboratory for the proper diagnosis of AIL.

Unverified Answer

What is the survival rate for immunoblastic lymphadenopathy?

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The prognosis of ILD/AITD has not improved in a decade despite improvement in management. Long term survival in these cohorts is in the 20-50% range. Younger age at diagnosis is associated with better survival.

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What are the common side effects of brentuximab vedotin?

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The common side effects of brentuximab vedotin and its constituents were similar to other antimitotic agents and were not different for patients of all age groups analyzed. Common side effects from brentuximab vedotin treatment included grade 2 to 4 hypersensitivity and grade 1/2 infusion reactions.

Unverified Answer
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