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A Study of DR-01 in Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas

This research study is looking at a new treatment called DR-01 for adults with specific blood cancers, known as Large Granular Lymphocytic Leukemia (LGLL) or different kinds of cytotoxic lymphomas. This is one of the first times DR-01 is being given to people, and its main goals are to check if it's safe and how well people tolerate it. Researchers will also look at how the body handles the medicine and if it shows any signs of shrinking the cancers. The study involves different stages, starting with a focus on safety and then moving on to see its effects on the illness. It's open to men and women over 18 years old.

At a glance

What is this study about?

This study is investigating a new medicine, called DR-01, for adults who have been diagnosed with certain types of blood cancers. These cancers include Large Granular Lymphocytic Leukemia (LGLL) and a group of conditions called 'cytotoxic lymphomas'. You might be familiar with some of the more specific names like Hepatosplenic T-cell Lymphoma or Aggressive NK Cell Leukemia, among others. The main aim of this research is to see if DR-01 is a safe treatment and how well people tolerate it. \n\nThe study is divided into two main parts. The first part, called Phase 1, focuses on carefully checking the safety of DR-01 and finding the right dose. Once a safe dose is established, the study moves into Phase 2, where researchers will further look at how well the medicine works against these cancers and how the body processes it. \n\nBeing a 'first-in-human' study means this is one of the first times this drug is being given to people. This kind of research is really important because it helps scientists understand more about how new potential treatments work and whether they could become future options for patients. Remember, this study is about gathering information, and participation is always your choice.

Key takeaways

  • It's a study testing a new medicine (DR-01) for certain blood cancers.
  • The primary goals are to check safety and how well people tolerate the medicine.
  • It's for adults with Large Granular Lymphocytic Leukemia (LGLL) or cytotoxic lymphomas.
  • You must have tried at least one previous treatment for your cancer.
  • Regular clinic visits, blood tests, and scans will be part of participation.
  • You can stop participating at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old and fully understand what the study involves before agreeing to take part. It's also important that your main organs, like your kidneys and liver, are working properly, and your blood clotting is normal. \n\nIf you are a woman who could become pregnant, you'll need to use a very effective method of contraception throughout the study and for 12 months after your last dose of DR-01. Men taking part will also need to use an effective method of contraception. \n\nFor those with LGLL, you must have tried at least one other treatment before. If you have a cytotoxic lymphoma, you must have also tried at least one past treatment. Additionally, for people with cytotoxic lymphomas, the study will need either a tissue sample taken after your last treatment, or you must be willing to have a new biopsy (a small tissue sample taken for examination). Your diagnosis must also be officially confirmed by a specialist.

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. Are you 18 years old or older?
  2. Do you understand what the study involves and agree to sign a consent form?
  3. Are your major organs (like kidneys, liver) working well?
  4. Have you already tried at least one different treatment for your cancer?
  5. Are you willing to use contraception during and after the study (if applicable)?
  6. If you have a cytotoxic lymphoma, is a recent tissue sample available, or are you willing to have a new biopsy?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given the study medicine, DR-01. The amount of DR-01 you receive will be carefully monitored, especially in the early stages of the study, to find the safest and most effective dose. \n\nThroughout your time in the study, you'll have regular visits to the clinic. During these visits, the research team will perform various tests and checks. These will likely include blood tests, physical examinations, and scans (like CT or PET scans) to see how your body is reacting to the medicine and how your cancer might be changing. You might also have additional biopsies if required for follow-up. \n\nThe research team will provide specific details on how often these visits will be, what each visit will involve, and how long you are expected to be in the study overall. You'll also have a follow-up period after your last dose of DR-01 to monitor your health.

Potential risks and benefits

Taking part in any clinical study comes with potential benefits and risks. A potential benefit of joining this study is that you might have access to a new experimental medicine, DR-01, that is not yet available to the general public. While there's no guarantee, this treatment could potentially help with your condition. However, because DR-01 is a new medicine, there might be side effects or risks that we don't fully know about yet. The study team will explain all known or expected risks to you, and you'll be closely monitored for any reactions. You are always in control and have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (37)

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  • Dren Investigational Site 1
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  • Dren Investigational Site 2
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  • Dren Investigational Site 2
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    Pittsburgh, United States· Recruiting
  • Dren Investigational Site
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    Houston, United States· Recruiting

Common questions

What is DR-01?

DR-01 is a new medicine being tested in this study for specific types of blood cancers. It's currently in the research stage and not yet a widely approved treatment.

What kind of cancers is this study for?

This study is for adults with Large Granular Lymphocytic Leukemia (LGLL) or certain types of cytotoxic lymphomas, which are blood cancers.

Is this a new treatment?

Yes, this is a 'first-in-human' study, meaning DR-01 is being given to people for the first time. Researchers want to learn about its safety and effects.

Will I get better if I join?

We cannot guarantee that you will get better. The study aims to find out if DR-01 is safe and if it shows signs of helping with these cancers.

Can I leave the study if I change my mind?

Yes, you have the right to leave the study at any time, for any reason, without affecting your medical care.

How to find out more

Dren Central Contact

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 DR-01 in Subjects With Large Granular Lymphocytic…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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