CLINICAL TRIAL

Nivolumab for Hodgkin Disease

Stage III
Recruiting · 18+ · All Sexes · Detroit, MI

This study is evaluating whether a drug may help treat Hodgkin lymphoma.

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About the trial for Hodgkin Disease

Eligible Conditions
Hodgkin Disease · Lymphoma · Lymphoma, Hodgkins

Treatment Groups

This trial involves 2 different treatments. Nivolumab is the primary treatment being studied. Participants will be divided into 2 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
Bleomycin
DRUG
+
Nivolumab
DRUG
+
doxorubicin
DRUG
+
vinblastine
DRUG
+
dacarbazine
DRUG
Experimental Group 2
Nivolumab
DRUG
+
doxorubicin
DRUG
+
vinblastine
DRUG
+
dacarbazine
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bleomycin
FDA approved
Nivolumab
FDA approved
Doxorubicin
FDA approved
Vinblastine
FDA approved
Dacarbazine
FDA approved

Eligibility

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Histologic diagnosis of classical Hodgkin lymphoma
This means that WOCBP cannot have a positive pregnancy test within 24 hours of the start of the study drug show original
Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 2 weeks prior to the start of study drug show original
The patients in cohort B will be those who are 60 years or older and have not been treated for classical Hodgkin lymphoma, regardless of their stage. show original
Patients less than 60 years of age with stage III or IV HL are eligible for phase II of the study show original
scan The use of FDG-PET/CT scanning to diagnose diseases that are FDG-avid can be very helpful show original
This study is for non-MSK patients who have been diagnosed with PET-2 positive disease. show original
Ann Arbor Stage III or IV disease (Cohort A only)
Reliable methods of birth control include a double barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, tubal ligation or total abstinence during the study
Patients who are age less than 60, have untreated stage III or IV classical Hodgkin lymphoma, and have a baseline IPS ≥3 OR if their PET scan after 2 cycles of ABVD is positive (Deauville 4 or 5) will be eligible for cohort A of the study show original
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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: 2 year
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 2 year.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Nivolumab will improve 2 primary outcomes in patients with Hodgkin Disease. Measurement will happen over the course of 2 years.

number of patients who have dose limiting toxicity
2 YEARS
For this objective, the standard 3+3 scheme will be used. Initially, 3 patients will enroll onto dose level 1. If no patients experience DLT, enrollment will proceed to the next dose level. If 1 DLT is observed, 3 additional patients will enroll onto dose level 1. If 1 or fewer patients out of 6 experience DLT, enrollment will proceed to the next dose level. If 2 or more DLTs are observed at a given dose level, the previous dose will be declared the MTD. Adverse events will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. If CTCAE grading does not exist for an adverse event, the severity of mild, moderate, severe, and life-threatening, corresponding to Grades 1 - 4, will be used.
2 YEARS
Phase II- progression free survival
2 YEAR
The updated response criteria entitled "The Lugano Classification" system will be applied to define complete response, partial response, and progression of disease in this study.
2 YEAR

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 causes hodgkin disease?

Hodgkin disease may be triggered by an infection in you or by exposures to chemicals that are thought to be carcinogenic or otherwise deleterious to lymphocytes, particularly those that cause DNA damage, or by cigarette smoking. More information on potential risk factors is needed to establish whether risk factors play more important roles than genetics in the development of Hodgkin disease in humans. The most convincing evidence that cigarette smoking increases risk is in children, but the magnitude of the increase is small and is less conclusive for adults. A similar increase in risk is seen in those exposed to benzene, a chemical in cigarette smoke. The same is not seen for those exposed to some kinds of UV radiation.

Anonymous Patient Answer

What are the signs of hodgkin disease?

ix) a palpable mass anywhere, if a lesion, ix) the presence of lymphadenopathy if lymphadenopathy, ix) an adenopathy if adenopathy, and ix) a lymphadenopathy if lymphadenopathy. ix) palpable mass if a lesion, ix) the presence of lymphadenopathy if lymphadenopathy, ix) the presence of an adenopathy if an adenopathy, and ix) a lymphadenopathy if an adenopathy.

Anonymous Patient Answer

Can hodgkin disease be cured?

The overall 5-year survival for patients with Stage IV HD was 36%. The 5-year OS for patients treated with a standard therapy protocol was 35%. Although this was not statistically significant in univariate analysis, the results of this retrospective study do not support the use of current standard therapy protocols to treat this disease.

Anonymous Patient Answer

What are common treatments for hodgkin disease?

Treatment options for Hodgkin's disease are dependent on the extent, type, and location of the disease in the body. Patients receiving corticotherapy have poorer 5-year overall and progression-free survival compared to patients without corticotherapy. There is no clear evidence that cranially administered radiotherapy improves survival compared to the risks and side-effect profile of corticotherapy. Radiation therapy is associated with a markedly low incidence of severe acute (and often serious) GI toxicity when used as a palliative treatment option for patients with high-risk disease in the neck or mediastinum. Chemotherapy can be used alone or in combination with chemotherapy or radiotherapy.

Anonymous Patient Answer

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

Around 1,200,000 people will be diagnosed with Hodgkin disease each year, making it the sixth-most common cancer in American men. Of new cases of Hodgkin disease 10,100 people succumb to the disease each year, making it the most common cause of cancer-related death among young adults in the United States.

Anonymous Patient Answer

What is hodgkin disease?

The common name 'Hodgkin disease' implies two things—it is synonymous with Hodgkin lymphoma and a form of non-Hodgkin lymphoma (NHL). The disease is most prevalent in young men and has low cure rates with current treatment.

Anonymous Patient Answer

What is the average age someone gets hodgkin disease?

The average age a person gets diagnosed with Hodgkin disease is 39 years, but the age of diagnosis varies depending on the location and racial ancestry among other factors.

Anonymous Patient Answer

How quickly does hodgkin disease spread?

If a patient has a history of lymph node cancer or the development of a second malignancy within the past 10 years, prompt examination to look for involvement of the primary site should be undertaken. If a patient has a new noncontiguous primary neoplasm with symptoms of a mass or extracutaneous nodules, then a biopsy from the site of the new neoplasm should be conducted. Patients with symptomatic LDH-HOD seem to have an acceptable 3 year overall survival of 96%.

Anonymous Patient Answer

Who should consider clinical trials for hodgkin disease?

All patients with HD should consider enrolling in clinical trials. Patients who have a prolonged course of therapy with high-dose CHOP chemotherapy are particularly likely to benefit; this group might also be eligible for trials involving a new and nontoxic induction regimen.

Anonymous Patient Answer

What is the survival rate for hodgkin disease?

Patients with HD have variable survival rates according to racial, age, and T stage. There is also variation in the use of chemotherapy according to the characteristics of the patient, including the presence of extrapleural disease and the extent of disease at the time of diagnosis.

Anonymous Patient Answer

How serious can hodgkin disease be?

Despite several years of treatment, about half the people with metastatic non-bulky disease had a sustained response to treatment. The majority of patients had minimal symptoms for some years after diagnosis. Most patients were satisfied or very satisfied with their treatment. [There is a range of hodgkins disease treatments, including surgery, chemotherapy, and radiotherapy; about 10% of people have no or very little symptoms or complications, according to a survey in the Netherlands, 2013. (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC39073326/fulltext.htm)].

Anonymous Patient Answer

Have there been any new discoveries for treating hodgkin disease?

There have not been any dramatic advancements for treating hodgkin disease compared to today. Treatment is still a complex and expensive process so even if there were a new way of treating this disease, only a few people would probably benefit from the treatment. Current treatment is still very effective and affordable so it’s crucial for doctors to work hard to continue studying this disease.

Anonymous Patient Answer
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