Nivolumab for Hodgkin Disease

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Fred Hutchinson Cancer Research Center, Seattle, WA
Hodgkin Disease+3 More
Nivolumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether a combination of chemotherapy and immunotherapy may help treat Hodgkin lymphoma.

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Eligible Conditions

  • Hodgkin Disease
  • Refractory Hodgkin Lymphoma
  • Recurrent Hodgkin Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Hodgkin Disease

Study Objectives

This trial is evaluating whether Nivolumab will improve 2 primary outcomes, 7 secondary outcomes, and 2 other outcomes in patients with Hodgkin Disease. Measurement will happen over the course of 1 year after primary outcome is met.

Year 1
Complete response rate autologous stem cell transplantation assessed by Lugano criteria
Year 2
Overall survival of hematopoietic cell transplantation
Year 2
Progression free survival of hematopoietic cell transplantation
Year 2
Relapse/progression event
Year 2
Overall survival
Year 2
Progression free survival
Year 2
Non-relapse mortality
Year 2
Overall response rate
Up to 2 years
Incidence of adverse events assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
Role of PDL1/L2, CD68 on lymphoma specimens
Role of T/B/natural killer cell subsets in the peripheral blood

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Hodgkin Disease

Trial Design

2 Treatment Groups

Cohort A (nivolumab, etoposide, ifosfamide, carboplatin)
1 of 2
Cohort B (nivolumab, etoposide, ifosfamide, carboplatin)
1 of 2
Experimental Treatment

This trial requires 78 total participants across 2 different 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 2 and have already been tested with other people.

Cohort A (nivolumab, etoposide, ifosfamide, carboplatin)Patients receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 14 days for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients with CR or PR receive nivolumab for an additional 6 weeks. Patients with only SD after 6-week nivolumab treatment receive nivolumab for an additional 6 weeks or receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2 every 21 days for 6 weeks per physician/investigator's discretion. Patients with PD after 6-week nivolumab treatment or patients with PR, SD, or PD after 12-week nivolumab treatment receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Cohort B (nivolumab, etoposide, ifosfamide, carboplatin)Patients receive nivolumab IV over 30 minutes on cycle 1 (cycle 1 is 14 days), day 1 in the absence of disease progression or unacceptable toxicity. Beginning in cycle 2, patients receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Etoposide
FDA approved
Ifosfamide
FDA approved
Carboplatin
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

Fred Hutchinson Cancer Research Center - Seattle, WA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. 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.

Mark “yes” if the following statements are true for you:
Patients must have histologically documented or cytologically confirmed Hodgkin lymphoma; confirmation must include CD30 expression
Patients must be either refractory to or relapsed after only induction therapy; patients who do not achieve CR after induction therapy are considered primary refractory and are allowed to enter study
> 40 kg
Absolute neutrophil count (ANC) >= 1500/uL; filgrastim can be given before and during treatment to achieve target ANC >= 1500 uL
Platelet (Plt) >= 75,000/uL
Hemoglobin >= 8.5 g/dl
Platelet transfusion and packed red blood cell transfusion can also be given prior to the start of treatment and treatment to achieve a target plt >= 75,000/uL and hemoglobin of >= 8.5 g/dl, provided that patients have not received growth factors for at least 14 days prior to entering trial
Patients must have measurable disease > 1.5 cm evidenced by computed tomography (CT) scan of the neck/chest/abdomen/pelvis or CT/positron emission tomography (PET) scans
Life expectancy of greater than 3 months
Eastern Cooperative Oncology Group (ECOG) of 0-2

Patient Q&A Section

What are the signs of hodgkin disease?

"Signs of HD may include an enlarged, swollen cervical lymph node. Symptoms may be painless or painful and involve the groin or thighs. Signs of HD typically persist for 3 months or more. HD involves the bone marrow, and causes high levels of white cells.\n" - Anonymous Online Contributor

Unverified Answer

Can hodgkin disease be cured?

"The cure rate is between 10-20%. Early detection and treatment is essential. Treatment is necessary to prevent irreversible deformities, but the main goal of treatment is, most importantly, to control the disease." - Anonymous Online Contributor

Unverified Answer

What causes hodgkin disease?

"When an erythematous mass is of unknown cause, the following differential diagnoses should arise in the differential diagnosis and should be considered: pyoderma gangrenosum (early), bacterial cellulitis (late), and lymphoma (malignant cells)." - Anonymous Online Contributor

Unverified Answer

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

"The incidence of hodgkin disease is rising in the United States. Despite the declining incidence of Hodgkin disease in the United Kingdom, the prevalence of the disease in the United Kingdom is increasing. A study of the incidence of hodgkin disease among the UK population is warranted." - Anonymous Online Contributor

Unverified Answer

What are common treatments for hodgkin disease?

"This preliminary analysis suggests that many patients with Hodgkin's live well with chemotherapy. More research is needed as to the most effective chemotherapy and the long-term effects of treatment, such as the risk of developing second primary cancer and treatment-related side effects such as bone marrow failure, which may lead to secondary death." - Anonymous Online Contributor

Unverified Answer

What is hodgkin disease?

"In children, Hodgkin's disease is a type of highly aggressive (and often fatal) non-Hodgkin lymphoma characterized by the malignancy of B cells affecting the spleen and lymph nodes.\n" - Anonymous Online Contributor

Unverified Answer

What are the latest developments in nivolumab for therapeutic use?

"There are many nivolumab development programs underway and many new immunotherapies are in progress. It’s very exciting for immunotherapy as research is shifting out of the traditional target molecules (e.g. CTLA4 T cell checkpoint inhibitors) and into target tissues and organs and the immune microenvironment." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of hodgkin disease?

"We have found an increased risk of Hodgkin disease amongst children with Down syndrome who had an autoimmune etiology in the absence of Epstein Barr virus (EBV) infection." - Anonymous Online Contributor

Unverified Answer

Is nivolumab typically used in combination with any other treatments?

"Nivolumab seems to be used more frequently in combination with other treatment types. Furthermore, in patients treated with nivolumab and chemotherapy a significant improvement in OS, PFS, and CFS was evident." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of nivolumab?

"Common side effects in this pooled analysis of 2101 patients included: fatigue, insomnia, nausea and/or vomiting, constipation, diarrhea, injection-site reactions, and stomatitis. Less common side effects included upper respiratory tract infections (7/1076 (6.4%)), peripheral edema (1/1076 (0.9%)), bronchospasm (1/1076 (0.9%)), hypertension (1/1076 (0.9%)), and hypothyroidism (1/1076 (0.9%)). Nivolumab monotherapy was associated with an increased rate of infections and infusion-related reactions compared with chemotherapy alone in patients with Hodgkin's lymphoma." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for hodgkin disease?

"The average survival rate for patients with good risk stage III-IHD is 98%; 94% in stage III-IIHL. Survival rate for stage IIHL (70% 5 yr; 72% 10 yr) and IVHL (55% 5 yr; 46% 10 yr) are lower in comparison to these two risk groups." - 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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