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RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study of BGB-11417 in Participants With Myeloid Malignancies

This research is investigating a new drug called BGB-11417 for adults with certain types of blood cancer. These include acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS), as well as a related condition called myelodysplastic/myeloproliferative neoplasm (MDS/MPN). The main goals are to check how safe the drug is, how well people tolerate it, and to find the best dose to use in future studies. The researchers also want to see if BGB-11417 can help treat these cancers, either by itself or when given alongside another common cancer drug called azacitidine. This study is in the early stages (Phase 1 and Phase 2), meaning it's one of the first times this drug is being tested in a larger group of people.

At a glance

Status
Recruiting
Phase
PHASE1, PHASE2
Sponsor
BeiGene
Enrolment target
260
Start
24 May 2021
Estimated completion
08 Feb 2028

What is this study about?

This study is about exploring a new medication, BGB-11417, for conditions that affect the blood and bone marrow, specifically acute myeloid leukaemia (AML), myelodysplastic syndromes (MDS), and a related condition called myelodysplastic/myeloproliferative neoplasm (MDS/MPN). These conditions involve problems with how your body makes blood cells.

The main aim of this research is to understand how safe BGB-11417 is and how well people tolerate it. When treatments are new, it's really important to find out if they cause any unwanted side effects. The study will also help doctors work out the best amount of the drug to give. On top of that, they want to see if this new drug can help treat these conditions, either by itself or when combined with a medicine often used for these cancers, called azacitidine.

This kind of research is vital because it helps doctors find new and potentially better ways to treat serious illnesses like blood cancers. By taking part, you could contribute to medical knowledge that could help future patients. The study is split into two parts (Phase 1 and Phase 2), which means it's a careful step-by-step process to gather information about this new potential treatment.

Key takeaways

  • This study is testing a new drug (BGB-11417) for certain blood cancers.
  • It aims to find out if the drug is safe, the best dose, and if it helps patients.
  • The drug might be given alone or with another treatment, azacitidine.
  • It’s for adults diagnosed with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS).
  • Participation involves regular hospital visits for check-ups and monitoring.
  • You can stop participating at any time if you change your mind.

Who may be eligible?

To join this study, doctors will check if you meet certain requirements. You must have a confirmed diagnosis of acute myeloid leukaemia (AML, but not a specific type called acute promyelocytic leukaemia), myelodysplastic syndromes (MDS), or myelodysplastic/myeloproliferative neoplasm (MDS/MPN). You also need to be generally well enough to take part, as measured by a common health check. Your organs, like your kidneys and liver, need to be working well enough, and doctors will assess that you are expected to live for more than 12 weeks.

There are also some reasons why you might not be able to join. For example, if you have acute promyelocytic leukaemia, or if your cancer has spread to your brain or spinal cord. If you've had certain other cancers recently, or if you have specific blood conditions like myelofibrosis that aren't the focus of this study, you wouldn't be able to participate. Also, if you've previously been treated with a similar type of drug to BGB-11417, called a B-cell lymphoma-2 inhibitor, you wouldn't be eligible.

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. Do I have a confirmed diagnosis of AML (not acute promyelocytic type), MDS, or MDS/MPN?
  2. Am I generally well enough to take part in a study?
  3. Are my kidneys and liver working well enough?
  4. Have I avoided certain types of previous cancer treatments related to this drug?
  5. Don't I have other specific blood cancers, like myelofibrosis, that are not the focus of this study?
  6. Do I not have leukaemia in my brain or spinal cord?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study drug, BGB-11417, which might be given alone or with azacitidine. You would have regular visits to the hospital or clinic for various checks and tests. These tests could include blood tests, health assessments, and scans to monitor your health and how the treatment is working. Doctors and nurses will explain how often these visits will be. The study will continue for a period, and you will be followed up to see how you are doing after treatment. The exact total duration often depends on how the treatment is affecting you and generally can last for several months or longer.

Potential risks and benefits

Taking part in a study like this offers potential benefits, such as access to a new treatment that isn't widely available yet, which might help your condition. You'll also receive close medical attention and monitoring. However, there are also potential risks; the new drug might cause side effects that are currently unknown or more severe than expected. All treatments, including those in studies, carry risks. You will be given full details of known side effects, and your health will be carefully monitored throughout. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (46)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • City of Hope National Medical Center
    Verified postcode
    Duarte, United States· Terminated
  • Tampa General Hospital
    Verified postcode
    Tampa, United States· Recruiting
  • Upmc Hillman Cancer Center(Univ of Pittsburgh)
    Verified postcode
    Pittsburgh, United States· Recruiting
  • Md Anderson Cancer Center
    Verified postcode
    Houston, United States· Recruiting
  • Medical College of Wisconsin
    Verified postcode
    Milwaukee, United States· Recruiting
  • Concord Repatriation General Hospital
    Verified postcode
    Concord, Australia· Recruiting
  • St George Hospital
    Verified postcode
    Kogarah, Australia· Recruiting
  • Orange Health Hospital
    Verified postcode
    Orange, Australia· Recruiting
  • Gold Coast University Hospital
    Verified postcode
    Southport, Australia· Recruiting
  • Monash Health
    Verified postcode
    Clayton, Australia· Recruiting
  • St Vincents Hospital Melbourne
    Verified postcode
    Fitzroy, Australia· Recruiting
  • Austin Health
    Verified postcode
    Heidelberg, Australia· Recruiting

Common questions

What is AML/MDS?

AML (Acute Myeloid Leukaemia) and MDS (Myelodysplastic Syndromes) are types of blood disorders where your bone marrow doesn't produce healthy blood cells properly.

What is BGB-11417?

BGB-11417 is a new drug being tested in this study. Researchers want to see if it can help treat these blood conditions.

What does 'monotherapy and in combination' mean?

It means some people might get BGB-11417 on its own (monotherapy), while others might get it along with another drug called azacitidine (in combination).

Will I know if I'm getting the new drug or the old one?

In this type of study, you'll be receiving the new drug (BGB-11417) either alone or with azacitidine. This isn't a placebo-controlled study.

How long will the study last?

The study's full duration isn't specified, but participation involves ongoing treatment and follow-up, which can last for several months or longer, depending on your individual response.

How to find out more

BeiGene

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

Interested in taking part?

Register your interest

Share your details and the research team for "A Study of BGB-11417 in Participants With Myeloid Malignanci…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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