All studies
Active not recruitingPHASE1, PHASE2INTERVENTIONAL

A(B)VD Followed by Nivolumab as Frontline Therapy for Higher Risk Patients With Classical Hodgkin Lymphoma (HL)

This clinical trial is designed to find better ways to treat Hodgkin lymphoma, specifically for patients who are considered to have a higher risk. Researchers are testing a new drug called Nivolumab alongside the usual treatment, ABVD (a combination of doxorubicin, bleomycin, vinblastine, and dacarbazine). The study is in two parts: first, to see if adding Nivolumab to ABVD is safe and what effects it has, and then to see if this new combination improves the chance of a cure for patients whose cancer hasn't fully responded after the first two cycles of standard ABVD, as shown on a special type of scan called a PET scan. This trial aims to give more people with Hodgkin lymphoma a better outcome.

At a glance

Status
Active not recruiting
Phase
PHASE1, PHASE2
Sponsor
Memorial Sloan Kettering Cancer Center
Enrolment target
82
Start
25 Jan 2017
Estimated completion
01 Jan 2027

What is this study about?

Hodgkin lymphoma is a type of cancer that affects your immune system. Doctors are always looking for better ways to treat it, especially for people whose cancer is more advanced or doesn't respond as well to initial treatments. This study is exploring a new approach that combines a standard treatment, called ABVD, with a newer drug named Nivolumab. ABVD is a well-known combination of chemotherapy drugs.

Nivolumab is a type of medicine called an immunotherapy. Immunotherapy works by helping your body's own immune system fight the cancer. The idea is that by adding Nivolumab to the existing ABVD treatment, it might boost the immune response and lead to a more effective way to get rid of the cancer and prevent it from coming back.

This trial has two main parts. The first part, called Phase 1, was primarily about making sure that combining Nivolumab with ABVD is safe and to understand any side effects. Now, the study is in Phase 2. This part focuses on whether adding Nivolumab actually improves the chances of cure for people with advanced Hodgkin lymphoma, especially if their cancer hasn't completely cleared up after the first two rounds of standard ABVD treatment, which doctors check using a special scan called a PET scan. Essentially, they want to see if this new combination can offer a better outcome for patients.

Key takeaways

  • This study combines standard chemotherapy (ABVD) with a new immune drug (Nivolumab).
  • It aims to improve cure rates for higher-risk Hodgkin lymphoma.
  • Your treatment path might depend on a PET scan after your first two chemotherapy cycles.
  • Nivolumab helps your immune system fight cancer.
  • The study is for people with untreated classical Hodgkin lymphoma, aged 18 or over.
  • Participation involves close monitoring with tests and scans.

Who may be eligible?

This study is looking for adults who have classical Hodgkin lymphoma that hasn't been treated yet. For younger patients (under 60 years old), the cancer needs to be in stages III or IV, meaning it's more widespread in the body. If you are 60 years old or older, you might be eligible regardless of the stage of your cancer.

To be considered, doctors need to confirm your diagnosis of classical Hodgkin lymphoma, and special scans (FDG-PET/CT) must show that the cancer cells are active. For some patients, especially those joining from certain hospitals (like MSK), you can join anytime during your first two cycles of ABVD treatment. However, if you're joining from other hospitals and are under 60, you'll generally need to have had a PET scan after your first two cycles of ABVD that shows your cancer hasn't completely responded to the initial treatment.

Women who could become pregnant will need to have negative pregnancy tests before starting the study drugs and use reliable birth control methods throughout the study. This is to ensure safety as some medicines can affect an unborn baby. Your medical team will thoroughly review all criteria to see if this study is suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. I have classical Hodgkin lymphoma that hasn't been treated yet.
  2. I am 18 years old or older.
  3. If I am under 60, my cancer is in stage III or IV.
  4. My cancer is confirmed by a biopsy and shows up on a PET scan.
  5. If I am a woman who could become pregnant, I am willing to use reliable birth control during the study.
Answer every question to see your result.

What does participation involve?

If you take part in this study, you'll start with two cycles of standard ABVD chemotherapy. After these two cycles, you'll have a special scan called a PET scan. What happens next depends on the results of that scan. If your scan shows the cancer is still active, you will receive four more cycles of treatment, which will include a combination of three chemotherapy drugs (AVD) plus the new drug, Nivolumab. If your scan shows the cancer has responded well, you'll continue with standard treatment (AVD or ABVD) without Nivolumab.

Throughout the study, you'll have regular appointments with your doctors, nurses, and the research team. These visits will include physical exams, blood tests, and imaging scans (like PET scans) to monitor your health, how the treatment is working, and to check for any side effects. The exact number and frequency of visits will be explained by the study team, but you can expect to be monitored closely during and after your treatment on the study.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to a new treatment (Nivolumab) that might improve your chances of a cure compared to standard treatment alone, especially if your cancer is harder to treat. However, there are also potential risks. Like all medications, Nivolumab and the chemotherapy drugs can have side effects, which can vary from mild to serious. These will be fully explained to you before you decide to join. The research team will closely monitor you for any side effects and will provide support. You are always in control of your participation; you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (10)

  • Karmanos Cancer Institute
    Verified postcode
    Detroit, United States
  • Memorial Sloan Kettering Basking Ridge
    Verified postcode
    Basking Ridge, United States
  • Hackensack Meridian Health
    Verified postcode
    Hackensack, United States
  • Memorial Sloan Kettering Monmouth
    Verified postcode
    Middletown, United States
  • Memorial Sloan Kettering Bergen
    Verified postcode
    Montvale, United States
  • Memorial Sloan Kettering Commack
    Verified postcode
    Commack, United States
  • Memorial Sloan Kettering Westchester
    Verified postcode
    Harrison, United States
  • Memorial Sloan Kettering Cancer Center
    Verified postcode
    New York, United States
  • Memorial Sloan Kettering Nassau
    Verified postcode
    Uniondale, United States
  • BC Cancer (Data Collection Only)
    Verified postcode
    Vancouver, Canada

Common questions

What is Hodgkin lymphoma?

Hodgkin lymphoma is a type of cancer that affects your body's immune system, specifically white blood cells called lymphocytes.

What is ABVD?

ABVD is a common combination of four chemotherapy drugs used to treat Hodgkin lymphoma.

What is Nivolumab?

Nivolumab is a newer type of drug called an immunotherapy. It helps your body's own immune system fight the cancer.

What is a PET scan?

A PET scan is a special imaging test that helps doctors see where cancer cells are active in your body and how they respond to treatment.

What does 'higher risk' Hodgkin lymphoma mean?

This usually means the Hodgkin lymphoma is more advanced (like stages III or IV) or has other features that suggest it might be harder to treat with standard therapies alone.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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