Brentuximab Vedotin for Hodgkin Disease

1
Effectiveness
1
Safety
Hopital l'Archet-CHU de Nice, Nice, France
Hodgkin Disease+13 More
Brentuximab Vedotin - Drug
Eligibility
18+
All Sexes
Eligible conditions
Hodgkin Disease

Study Summary

This study is evaluating the side effects and the best dose of brentuximab vedotin when given together with combination chemotherapy and to see how well they work in treating patients with stage II-IV human immunodeficiency virus (HIV)-associated Hodgkin lymphoma.

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Eligible Conditions

  • Hodgkin Disease
  • Lymphoma
  • Ann Arbor Stage IIB Hodgkin Lymphoma
  • Ann Arbor Stage IVA Hodgkin Lymphoma
  • Classic Hodgkin's Lymphoma
  • Human Immunodeficiency Virus (HIV) Infections
  • Ann Arbor Stage IVB Hodgkin Lymphoma
  • AIDS-Related Hodgkin Lymphoma
  • Ann Arbor Stage IIA Hodgkin Lymphoma
  • Ann Arbor Stage IIIA Hodgkin Lymphoma
  • Ann Arbor Stage IIIB Hodgkin Lymphoma
  • Ann Arbor Stage III Hodgkin Lymphoma
  • Ann Arbor Stage II Hodgkin Lymphoma
  • Ann Arbor Stage IV Hodgkin Lymphoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Brentuximab Vedotin will improve 2 primary outcomes and 13 secondary outcomes in patients with Hodgkin Disease. Measurement will happen over the course of 24 weeks (end of treatment).

2 years
Progression-free survival for patients using brentuximab vedotin plus AVD regimen with HIV-associated advanced stage Hodgkin lymphoma (Phase II)
Week 24
Prognostic value of FDG-PET in patient with HIV and HL with respect to 2 year progression free survival
28 days
Maximal tolerated dose of brentuximab vedotin when combined with doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine (AVD) chemotherapy regimen (Phase I)
5 years
Complete response rate
Event-free survival
Overall survival
Partial response rate
Baseline
Characterization of histologic subtypes in HIV-HL in the HAART era
HAART status
Prognostic value of fludeoxyglucose F-18 (FDG)-positron emission tomography (PET) in patient with HIV and Hodgkin lymphoma (HL) with respect to 2 year progression free survival
Up to 1 year
CD4 counts
CD8 counts
Viral load
Up to 5 years
Incidence of adverse events of AVD and brentuximab vedotin with highly active antiretroviral therapy (HAART)
Incidence of neurotoxicity in combination with HAART and AVD and brentuximab vedotin

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Treatment (brentuximab and combination chemotherapy)

This trial requires 43 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 1 & 2 and have already been tested with other people.

Treatment (brentuximab and combination chemotherapy)Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brentuximab vedotin
FDA approved
Dacarbazine
FDA approved
Doxorubicin
FDA approved
Vinblastine
FDA approved

Trial Logistics

Trial Timeline

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

Closest Location

UCLA Center for Clinical AIDS Research and Education - Los Angeles, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
for the R-EOD The histologic diagnosis of CD30-positive classical HL as defined by the 2008 World Health Organization (WHO) Classification of Hematological diseases; nodular lymphocyte predominant Hodgkin lymphoma is not eligible for the Reed-Sternberg-Oversized (R-EOD) classification. show original
Individuals with HIV-related classical HL must not have received treatment with steroids, radiation, or cyclophosphamide within the previous two weeks. show original
This text states that a normal baseline cardiac ejection fraction is 50% or higher. show original
OR HIV-1 antibody detection by a commercially licensed HIV-1 antibody assay with a reactive result show original
Providing care coordination services and referral to available care and support services, as needed The document records the diagnosis of HIV by a licensed health care provider show original
A document that shows that a patient has been prescribed ART by a licensed health care provider. show original
Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 western blot confirmation or HIV rapid multispot antibody differentiation assay
NOTE: A "licensed" assay refers to a United States (US) Food and Drug Administration (FDA)-approved assay, which is required for all investigational new drug (IND) studies
Creatinine levels below 1.5 mg/dL are considered normal, but if the creatinine level is higher than 1.5 mg/dL, the creatinine clearance must be at least 60 mL/minute. show original
This text is about a cancer staging system 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 the signs of hodgkin disease?

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The only signs of hodgkin disease are pain in the lymph nodes in the neck, chest, or armpits. An enlarged spleen or low white blood cell count may be present in some patients. The signs usually begin with a person in their 45s.\n

Unverified Answer

How many people get hodgkin disease a year in the United States?

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Between 11 and 19.2 per 100,000 Caucasian males and 10.6 and 8.5 per 100,000 Caucasian females develop Hodgkin disease each year. This has resulted in the average cumulative lifetime risk of developing Hodgkin disease being 2.14% (males) and 1.88% (females). It is estimated that every year, more than 1 in 1000 men and women are diagnosed with Hodgkin disease in the United States.

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How does brentuximab vedotin work?

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Brentuximab vedotin can produce complete tumor response in patients with relapsed Hodgkin lymphoma. There was little evidence for remission or progression-free survival in subjects with a complete response (CR).

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What is the latest research for hodgkin disease?

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Currently, there are very few new treatments that have been developed or tested for patients with hodgkin disease. More research is needed to develop novel strategies for treatment.

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What is hodgkin disease?

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HD is a rare disease of the blood and is characterized by a progressive enlargement and subsequent obstruction of the small tributary veins of the lymph nodes. It is the fifth most common cause of primary mediastinal lymphadenopathy and one of the most common diagnoses in Hodgkin disease from America.\n

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Can hodgkin disease be cured?

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Although no cures for Hodgkin disease exist, a number of targeted treatments are being developed and studied, such as rituximab, which has had some success in reducing symptoms in some cases. Results from a recent paper suggest that Hodgkin lymphoma may, in principle, be treated, at least in some cases, with targeted therapies specifically designed and developed to fight the illness.

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What are common treatments for hodgkin disease?

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In a real-life setting, the most common treatments for HD are chemotherapy, surgery, and splenectomy; in this study, radiation was the treatment with the highest percentage of use.

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What causes hodgkin disease?

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Most cases of HD do not develop from a viral infection. HD remains an incurable condition, and patients should, therefore, be aware that the disease may be a hereditary condition that affects more than half of cases.

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How serious can hodgkin disease be?

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Hodgkin disease is a very serious condition with a high incidence of death, and the prognosis is worse for patients who are young (aged 15-28 years) and Caucasian. However, this patient group is often overlooked due to a high rate of confusion due to similar symptom presentations, and in many cases the clinical and radiographic features are nonspecific, hence the delay in diagnosis and treatment.

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What does brentuximab vedotin usually treat?

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Brentuximab vedotin is often administered at full dose, instead of the standard 50 mg/m2 (maximum 250 mg/m of body surface area) dose, to reduce drug-related toxicities. This may be justified for patients who cannot tolerate the full dose due to tumor load, or if tumors are small and would not be exposed to the full dose due to uncertainties in dosing. However, these decisions are complex and require individualized medical knowledge and discussion.

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Has brentuximab vedotin proven to be more effective than a placebo?

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In patients with relapsed indolent CD30(+) Hodgkin lymphoma (HL), brentuximab vedotin was more effective than a placebo in terms of overall survival and progression-free survival.

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What are the chances of developing hodgkin disease?

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There are many different routes to developing HD: genetic predisposition is common. It is a disease with relatively good prospects of cure if found early.

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