Brentuximab Vedotin for Refractory Hodgkin Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
City of Hope Medical Center, Duarte, CA
Refractory Hodgkin Lymphoma+3 More
Brentuximab Vedotin - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating the side effects and best dose of brentuximab vedotin and cyclosporine when given together with verapamil hydrochloride in treating patients with Hodgkin lymphoma that has come back (relapsed) or does not respond to treatment (refract

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Eligible Conditions

  • Refractory Hodgkin Lymphoma
  • Recurrent Hodgkin Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Refractory Hodgkin Lymphoma

Study Objectives

This trial is evaluating whether Brentuximab Vedotin will improve 1 primary outcome, 7 secondary outcomes, and 2 other outcomes in patients with Refractory Hodgkin Lymphoma. Measurement will happen over the course of Up to 21 days.

Year 2
Overall survival
Year 2
Progression-free survival
Up to 2 years
Complete response rate assessed by Cheson 2014 criteria
Duration of complete response
Duration of overall response
Incidence of adverse events assessed
Overall response rate (complete response + partial response)
Percentage of CD30, CD68, and drug exporters
Pharmacokinetics of monomethyl auristatin E (MMAE)
Up to 21 days
Dose-limiting toxicity

Trial Safety

Safety Progress

1 of 3

Other trials for Refractory Hodgkin Lymphoma

Trial Design

1 Treatment Group

Treatment (cyclosporine, verapamil, brentuximab vedotin)
1 of 1
Experimental Treatment

This trial requires 29 total participants across 1 different treatment group

This trial involves a single treatment. 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 and are in the first stage of evaluation with people.

Treatment (cyclosporine, verapamil, brentuximab vedotin)Patients receive cyclosporine PO BID on days 1-5, verapamil hydrochloride PO QID on days 1-5, and brentuximab vedotin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brentuximab vedotin
FDA approved
Cyclosporine
FDA approved
Verapamil
FDA approved

Trial Logistics

Trial Timeline

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

Closest Location

City of Hope Medical Center - Duarte, CA

Eligibility Criteria

This trial is for patients born any sex of any age. You must have received 1 prior treatment for Refractory Hodgkin Lymphoma or one of the other 3 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:
Patients must be willing to provide a fresh tumor biopsy or an archived tumor biopsy for research purposes show original
A score of 0-2 on the ECOG performance scale means that the person is not incapacitated and is able to carry out most activities of daily living. show original
The life expectancy for a person with a particular illness is greater than three months. show original
to be enrolled in this trial This trial is for patients who have Hodgkin lymphoma that has been documented by a histology report or by a cytology report. show original
of the chest and/or abdomen (abd) Patient must have a tumor that is at least 1.5 cm wide and can be seen on a CT scan or PET scan of the chest or abdomen. show original
form, if appropriate, indicating their understanding of the nature of the experimental procedure and its risks and benefits, before any experimental procedure may be performed on that patient show original
Voluntary written informed consent must be obtained before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Weight over 40 kg
Patients must be resistant to, or have relapsed after, at least 1 line of therapy. show original
An expansion cohort is a group of patients who are similar to each other and who are studied more closely than other patients in a clinical trial show original

Patient Q&A Section

What causes lymphoma?

"A causal relationship has been established between tobacco smoking and the development of lymphoma or the precursor lesion. For this, lymphoma is not a pure'smoker's disease'. More recent studies have questioned whether a causal relationship exists between Epstein-Barr virus and non-Hodgkin's lymphoma, but no causal role has been established yet." - Anonymous Online Contributor

Unverified Answer

What are common treatments for lymphoma?

"In recent years, chemotherapy and radiation treatment have become more standard practice. In older cases, surgery and/or radiation are still a valid treatment option. However, the trend in treating lymphoma is towards more individualized treatment, with the use of chemotherapy and/or radiation therapy in a more conservative manner, particularly for small B-cell lymphomas." - Anonymous Online Contributor

Unverified Answer

What is lymphoma?

"A lymphoma is a cancer of the lymphatic system. In the UK more than 60 cases of non-IgM lymphoma a year are diagnosed, most commonly Burkitt's and non-Burkitt's Burkitt's-like lymphomas. The most common form of non-IgM lymphoma is mediastinal B-cell lymphomias. B-cells develop from the precursors of lymphoma. A lymphoma is diagnosed by analyzing the cells." - Anonymous Online Contributor

Unverified Answer

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

"More than three quarters of all patients with lymphoma got their disease in the United States. More than one-third of all patients had either aggressive or indolent B-cell NHL." - Anonymous Online Contributor

Unverified Answer

What are the signs of lymphoma?

"Signs include the following: weight loss, bone pain, swollen lymph nodes, unexplained fatigue and malaise. Patients rarely complain of sore throat or swollen lymph nodes because these are common side effects of chemotherapy.\n" - Anonymous Online Contributor

Unverified Answer

Can lymphoma be cured?

"Despite the improvements in therapy and survival, approximately 50% of patients die from lymphoma in the United States each year. With better treatment, overall and median survival rates can be improved even further. It is impossible to assert that cure can be accomplished for every patient with lymphoma. What this article, the textbook reports, and the literature suggest must be recognized." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of lymphoma?

"This data suggested that a combination of viral infections, tobacco, drugs and environmental exposures may play a role in lymphoma. An association between smoking and certain subtypes of lymphoma is emerging, supporting the proposal that smoking exerts its effect by activating the immune system." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for lymphoma?

"Clinical trials are recommended for patients with both localized and advanced lymphoma in order to help ascertain treatment recommendations and prognoses in different lymphoma subtypes." - Anonymous Online Contributor

Unverified Answer

Does brentuximab vedotin improve quality of life for those with lymphoma?

"Overall, BV significantly improved the quality of life of patients with relapsed or refractory bulky lymphoma and was well tolerated, albeit requiring frequent administration. The improvement in quality of life was most pronounced for physical well-being and mobility, with the improvements tending to be greatest in those who were symptomatic after the initiation of BV." - Anonymous Online Contributor

Unverified Answer

How serious can lymphoma be?

"Although fatal cases of lymphoma have been reported from the 18th century, the majority of fatalities have been reported for lymphoma occurring after the age of 40 due to multiple causes (especially congestive heart failure), but they are rare in younger patients. Most patients with malignant tumours of B-lymphocytic (or B-cell lymphocytic) origin do very well. Older patients with B-cell lymphomas often die of septic shock, or pneumonia and/or secondary tumours." - Anonymous Online Contributor

Unverified Answer

What is the latest research for lymphoma?

"It’s a complex disease and there have not been new drugs released in the cancer drug pipeline, but a plethora of research continues. As for non-Hodgkin’s lymphoma, research is ongoing. Research on how to prevent the disease continuing is still being done at the cellular level. There is also some research underway on how well we can control, but not cure the disease or eradicate it from the person. A lot of it is aimed at immunotherapy and immunotoxins." - Anonymous Online Contributor

Unverified Answer

What does brentuximab vedotin usually treat?

"This novel therapy demonstrated durable responses with acceptable toxicity in this group of high-risk B-cell lymphoma. Brentuximab vedotin was safe and effective, and response data appear to be similar to our experience with other agents including rituximab." - 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.
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