CLINICAL TRIAL

Brentuximab Vedotin for Hodgkin Disease

Recruiting · Any Age · All Sexes · Baton Rouge, LA

This study is evaluating whether a combination of two immunotherapy drugs may help treat Hodgkin lymphoma.

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About the trial for Hodgkin Disease

Eligible Conditions
Lymphoma · Refractory Classic Hodgkin Lymphoma · Hodgkin Disease · Recurrent Classic Hodgkin Lymphoma

Treatment Groups

This trial involves 5 different treatments. Brentuximab Vedotin is the primary treatment being studied. Participants will be divided into 5 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Experimental Group 1
Brentuximab Vedotin
DRUG
+
Nivolumab
BIOLOGICAL
Experimental Group 2
Brentuximab Vedotin
DRUG
+
Ipilimumab
BIOLOGICAL
+
Nivolumab
BIOLOGICAL
Experimental Group 3
Brentuximab Vedotin
DRUG
+
Ipilimumab
BIOLOGICAL
+
Nivolumab
BIOLOGICAL
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brentuximab vedotin
FDA approved
Ipilimumab
FDA approved
Nivolumab
FDA approved

Eligibility

This trial is for patients born any sex of any age. You must have received 1 prior treatment for Hodgkin Disease or one of the other 3 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patients must have pathologically confirmed relapsed or refractory classical Hodgkin lymphoma (cHL); a biopsy at any relapse is acceptable; other histologies including lymphocyte predominant (LP) HL are not permitted
Patient of childbearing potential and/or sexually active patients must either abstain from sexual intercourse for the duration of their participation in the study or agree to use both single barrier contraception and birth control pills or implants for at least one week prior to the start of the study drug and continuing for 5 months after the last dose of study drug (for patients of childbearing potential) and for 7 months after the last dose of study drug (for patients who are sexually active with anyone of childbearing potential); should a patient become pregnant or suspect pregnancy while the patients or their partner is participating in this study, the patient (or the participating partner) should inform the treating physician immediately
PHASE I (ARMS A, B, C, D, E, F, G, H, I, X, Y, Z)
Age >= 18 years
Patients must have relapsed after first line chemotherapy; may have relapsed after autologous or allogeneic stem cell transplant, or have primary refractory disease; no upper limit for number of prior therapies; if status post allogeneic stem cell transplant, no active graft versus host disease
Patients may have received prior brentuximab vedotin, but must not have received brentuximab vedotin within 6 months prior to registration, and must not have relapsed within 6 months of receiving previous brentuximab vedotin; patients may not have received prior nivolumab or PD1/PDL1 axis agents; patients in the nivolumab/brentuximab cohorts ONLY (D, E, F, Y) may have received prior ipilimumab
Patients may have received other prior activating immunotherapies (i.e. checkpoint inhibitors), but must not have received them within 6 months prior to registration, and there must be no serious unresolved complication of therapy at the time of registration; for the purposes of this study monoclonal antibodies and antibody drug conjugates are not considered to be activating immunotherapies and there are no additional time restrictions on prior exposure to these agents (except prior brentuximab vedotin)
Eastern Cooperative Oncology Group (ECOG)-American College of Radiology Imaging Network (ACRIN) performance status between 0-2
Patients must have measurable disease; baseline measurements and evaluations must be obtained within 4 weeks of registration to the study; abnormal positron emission tomography (PET) scans will not constitute evaluable disease unless verified by a diagnostic quality computed tomography (CT) scan; patients must use the same imaging modality (CT or PET/CT) throughout the study
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 5 years.
View detailed reporting requirements
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Measurement Requirements

This trial is evaluating whether Brentuximab Vedotin will improve 2 primary outcomes, 10 secondary outcomes, and 12 other outcomes in patients with Hodgkin Disease. Measurement will happen over the course of Baseline to up to 6 weeks after completion of study treatment.

Effects of combinations on systemic immunity (Phase I and II)
BASELINE TO UP TO 6 WEEKS AFTER COMPLETION OF STUDY TREATMENT
Pre- and post-treatment levels of cytokines and T cell specific biomarkers (Phase I and II)
BASELINE TO UP TO 6 WEEKS AFTER COMPLETION OF STUDY TREATMENT
Pre- and post-treatment levels of these markers will be compared using the Wilcoxon signed-rank test with two-sided type I error of 0.1. Marker levels between patients who fail at 1-year vs. patients who are event-free at 1-year will be evaluated. Given limited data, the analyses of PD-1, co-expression of Tim-3 with PD-1, ICOS, sCD30, galectin-1 and the peripheral blood absolute lymphocyte to monocyte ratio will be mainly exploratory and will be summarized descriptively at the time-points described above. The association with PFS will be explored.
Percent change in CT size (SPD) and in CT tumor volume between baseline and during therapy
BASELINE UP TO CYCLE 10
Image data will be evaluated using Lugano response criteria with various D 5PS cut-offs in the entire cohort and in different therapy cohorts to determine if the existing set of criteria is sufficient to segregate the group into various response categories. Will correlate PFS, EFS, OS 5PS in two reading settings (1-3 [negative] vs 4-5 [positive] and D 5PS 1-4 [negative] vs 5 [positive]) (KM curve and log-rank testing).
Percent change in size (sum of perpendicular diameters [SPD]) on computed tomography (CT)
BASELINE UP TO CYCLE 10
Image data will be evaluated using Lugano response criteria with various D 5PS cut-offs in the entire cohort and in different therapy cohorts to determine if the existing set of criteria is sufficient to segregate the group into various response categories. Will correlate PFS, EFS, OS 5PS in two reading settings (1-3 [negative] vs 4-5 [positive] and D 5PS 1-4 [negative] vs 5 [positive]) (KM curve and log-rank testing).
Percent change in SUVmax, MTV and TLG between baseline and during therapy
BASELINE UP TO CYCLE 10
Image data will be evaluated using Lugano response criteria with various D 5PS cut-offs in the entire cohort and in different therapy cohorts to determine if the existing set of criteria is sufficient to segregate the group into various response categories. Will correlate PFS, EFS, OS 5PS in two reading settings (1-3 [negative] vs 4-5 [positive] and D 5PS 1-4 [negative] vs 5 [positive]) (KM curve and log-rank testing).
Metabolic whole body tumor volume (MTV) and tumor lesion glycolysis (TLG)
UP TO CYCLE 10
Image data will be evaluated using Lugano response criteria with various D 5PS cut-offs in the entire cohort and in different therapy cohorts to determine if the existing set of criteria is sufficient to segregate the group into various response categories. Will correlate PFS, EFS, OS 5PS in two reading settings (1-3 [negative] vs 4-5 [positive] and D 5PS 1-4 [negative] vs 5 [positive]) (KM curve and log-rank testing).
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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 hodgkin disease?

Common treatments for Hodgkin disease are: chemotherapy, radiation therapy (radiotherapy), or surgery. Immunotherapy (Rituximab, Etanercept), and biologics (Rituximab, Adcetris, interferons, anti-thymocyte globulin"

"Battaristis furtivana\n\nBattaristis furtivana is a species of moth of the family Gelechiidae. It is found in Mexico (Guerrero).

Anonymous Patient Answer

What causes hodgkin disease?

The main risk factor for developing a Hodgkin disease is family history. Some other risk factors include: cigarette smoking, radiation from a nuclear power plant and occupational exposure to pesticides or other agrochemicals. It is not yet understood if autoimmune disease is a cause of the disease, however the results of research into the matter are growing. Other known risk factors are: a lack of good physical activity, and obesity. When the risk factors are combined together they increase the chances of a diagnosis of the condition in a person.

Anonymous Patient Answer

What is hodgkin disease?

H.D. is a cancer that forms in the lymph nodes near the top of the body and often causes enlarged lymph nodes or inflammation of the skin, brain and other parts of the body. H.D. affects men and women equally and can be confused with other cancers. It is not uncommon for people with H.D. to have prolonged periods of remission.\n

Anonymous Patient Answer

Can hodgkin disease be cured?

Given that some men with Hodgkin disease and asymptomatic or minimally symptomatic disease can be cured, then there must be other factors that contribute to the development of bulky lymphomas in other patients who develop symptoms.

Anonymous Patient Answer

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

A total of 8,800 cases were diagnosed among children and teenagers in all 50 of the United States in 1984. About 300 cases were diagnosed each year in most States (Arizona, California, North Carolina, New Jersey, New Mexico, Ohio, and South Carolina). About 4,500 cases were diagnosed in the remaining 20 States. The highest incidence appears predominantly in white youths, and disproportionately in males. Although age-group and race-specific incidence of HOD is similar in North and South America, the incidence in individual United States cities varies widely from very high (e.g., San Antonio, 1,900 per 100,000), to very low (e.g., Denver, 0 per 100,000).

Anonymous Patient Answer

What are the signs of hodgkin disease?

This is not a comprehensive list of the signs of Hodgkin disease (HL). Nevertheless, these may be useful as initial steps when making a presentation to a person with a suspicion of HL. They can also be indicative of other complications of HL. Also some of these signs could be associated with the response to treatment, even when the disease is fully treated.

Anonymous Patient Answer

What is brentuximab vedotin?

Findings from a recent study, 5 of 39 (12.7%) patients receiving brentuximab vedotin plus docetaxel, etoposide, and prednisone (BETCHP) experienced symptomatic peripheral neuropathy, most often within 3 weeks of starting brentuximab vedotin plus docetaxel, etoposide, and prednisone. Peripheral neuropathy requiring intervention was associated with cumulative brentuximab vedotin dose.

Anonymous Patient Answer

Have there been any new discoveries for treating hodgkin disease?

Recent advances in biomedical and clinical research have enabled a novel approach to treat patients with hodgkin disease. This approach involves a combination of chemotherapy, radiation therapy, and immunotherapy. Today, the most effective ways to treat patients with these diseases are chemotherapy, radiation therapy, and bone marrow transplants, which can result in lengthy remission times. These therapies do not prevent the tumor from re-growing, and in most cases they result in devastating relapse during the remission times. Immunotherapy is also effective in treating patients with hodgkin disease. This treatment consists of administering antibodies to treat cancers such as that affecting the stomach, colon, breast, and lung. In this case, these antibodies are being used to prevent and diminish these cancers.

Anonymous Patient Answer

How quickly does hodgkin disease spread?

The clinical course of the disease varies with the disease stage at the diagnosis, as does the prognosis. The current knowledge on the biology of the disease should be used to find the best treatment for our patients at each stage.

Anonymous Patient Answer

Does brentuximab vedotin improve quality of life for those with hodgkin disease?

In this first cohort study, brentuximab vedotin significantly decreased pain and fatigue in patients with relapsed/refractory HL, while preserving the ability to perform most daily activities, leading to a high rate of satisfaction with treatment.

Anonymous Patient Answer

Is brentuximab vedotin safe for people?

Brentuximab vedotin given every two weeks appears to be safe and well-tolerated in patients with refractory CD20-positive Hodgkin lymphoma, even in adults. Efficacy is comparable to that of other treatment options.

Anonymous Patient Answer

What is the latest research for hodgkin disease?

According to a study conducted by Varma et al. in 2013, Dukes classification is still a very helpful diagnostic classification for predicting the progression of cancer, especially in Hodgkin lymphoma. The authors suggest that both clinical and pathological features of the disease may be used as classification criteria, including the presence of the B symptoms, the size of the lymph nodes, the number of lymph nodes involved, the presence or lack of bone involvement, etc. (page 12).

Anonymous Patient Answer
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