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Nivolumab + Chemotherapy for Hodgkin's Lymphoma
Study Summary
This trial is testing nivolumab in combination with ifosfamide, carboplatin, and etoposide to treat patients with Hodgkin lymphoma that has come back and does not respond to treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 541 Patients • NCT02041533Trial Design
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Who is running the clinical trial?
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- I haven't had chemotherapy or radiation in the last 3 weeks and have recovered from any side effects.I am following the required birth control measures.I have never been treated with PD-1 or PD-L1 inhibitors.I do not have any uncontrolled illnesses or active infections.I haven't had or been treated for another cancer in the last 3 years.I have a history of HIV, HCV, or HBV infection.My white blood cell count is high enough for treatment, or I can take medication to increase it.I understand the study's purpose and risks and can give informed consent.I finished treatment for an infection less than 14 days ago.I have not received second-line chemotherapy for Hodgkin lymphoma.I am receiving treatment for an active autoimmune disease.I can take care of myself and am up and about more than half of the day.My liver enzymes are within normal limits and my kidneys work well.I am a man and will use birth control if I'm with a woman who can have children.I have not received a live vaccine within the last 4 weeks.My liver function tests are within the required limits for Hodgkin lymphoma.I have active brain issues or a history of brain cancer spread.I am willing and able to follow all study requirements.My condition did not improve or has worsened after one treatment; I may have had radiation therapy.I weigh more than 40 kg.I am not currently on any experimental treatments or other cancer therapies.I haven't had a heart attack in the last 6 months and don't have severe heart issues.I do not have any severe illnesses that could risk my safety or affect the study's results.I haven't taken steroids or immunosuppressants in the last 14 days.My Hodgkin lymphoma has been confirmed and shows CD30 expression.I have a tumor larger than 1.5 cm confirmed by a CT or PET scan.My cancer did not respond or came back after initial treatment.
- Group 1: Cohort A (nivolumab, etoposide, ifosfamide, carboplatin)
- Group 2: Cohort B (nivolumab, etoposide, ifosfamide, carboplatin)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has the FDA sanctioned Nivolumab for use?
"Given the lack of proof for efficacy, but some evidence in support of safety, Nivolumab was assessed as having a security rating of 2."
What has Nivolumab been historically employed for?
"Nivolumab is an effective therapeutic intervention against malignant melanoma of skin, merkel cell cancer, and leukemia."
Are there opportunities available for individuals to join this research project?
"Unfortunately, no longer are participants being actively sought for this study which was initially posted on April 24th 2017. The information last updated on October 24th 2022. Fortunately, there remain 1723 clinical trials looking to enrol hodgkin disease patients and 2186 studies recruiting for Nivolumab treatment at present."
How extensive is the participant pool for this experiment?
"The recruitment period for this trial has ended. Initially posted on April 24th 2017 and last updated October 24th 2022, the study is no longer accepting enrolment. For those searching for alternative studies, there are 1723 trials actively recruiting hodgkin disease patients and 2186 clinical trials admitting participants with Nivolumab treatment needs."
Has there been any previous research involving Nivolumab?
"Presently, there are 2186 ongoing studies for Nivolumab and 436 of them have reached Phase 3. Most trials are concentrated in Leesburg, Virginia; however, a total of 102786 locations worldwide participate in the research related to this drug."
What objectives are being pursued by this research endeavor?
"The duration of this trial is expected to last up to 2 years and the primary goal will be evaluating the efficacy of autologous stem cell transplantation according to Lugano criteria. Secondary outcomes include overall response rate, relapse/progression event, and overall survival; all evaluated with Kaplan-Meier estimations."
How many healthcare institutions are currently conducting this clinical trial?
"This clinical trial is being conducted at Yale University in New Haven, Connecticut, City of Hope Medical Center in Duarte, California and M D Anderson Cancer Centre in Houston Texas as well as 4 additional institutions."
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