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RecruitingPHASE1, PHASE2INTERVENTIONAL

Safety and Efficacy of KRT-232 in Combination With Acalabrutinib in Subjects With R/R DLBCL or R/R CLL

This research study is looking at a new combination of two medicines, KRT-232 and acalabrutinib, for adults with specific blood cancers. These include Diffuse Large B-Cell Lymphoma (DLBCL) or Chronic Lymphocytic Leukaemia (CLL). The study is for people whose cancer has either returned after treatment (relapsed) or didn't respond to previous treatments (refractory). The main goal is to find out if this new combination is safe and effective in treating these conditions. It's an important step in finding better ways to help people with these types of cancer, especially when standard treatments haven't worked.

At a glance

Status
Recruiting
Phase
PHASE1, PHASE2
Sponsor
Kartos Therapeutics, Inc.
Enrolment target
84
Start
23 Feb 2021
Estimated completion
01 Mar 2024

What is this study about?

This study is investigating two medications, KRT-232 and acalabrutinib, when given together. The aim is to see how well they work and if they are safe for adults living with certain types of blood cancer. Specifically, the study is for people who have Diffuse Large B-Cell Lymphoma (DLBCL) or Chronic Lymphocytic Leukaemia (CLL).

You might be interested in this study if your cancer has come back after previous treatments, or if your previous treatments haven't worked as expected. The researchers are particularly interested in finding new options for people in this situation. KRT-232 is a new type of drug that works in a different way, and acalabrutinib is a medicine already used for some blood cancers.

By combining these two drugs, doctors hope to find a more effective way to treat these cancers. This research is important because it could lead to new treatment choices for people who need them most. It's part of an ongoing effort to improve outcomes and quality of life for those affected by DLBCL and CLL.

Key takeaways

  • This study is for adults with specific blood cancers (DLBCL or CLL) that have come back or not responded to previous treatments.
  • It's testing a combination of two oral medicines: KRT-232 and acalabrutinib.
  • The main goals are to see if this new combination is safe and effective.
  • You'll have regular hospital visits for monitoring and tests if you join.
  • You cannot join if you've had similar types of drugs before.

Who may be eligible?

To join this study, you must be an adult aged 18 or over. For those with Diffuse Large B-Cell Lymphoma (DLBCL), your cancer must have come back or not responded after at least two other treatments. If you can't have a stem cell transplant, you might be able to join after just one previous treatment. For those with Chronic Lymphocytic Leukaemia (CLL), your cancer must have come back or not responded after at least one previous treatment.

Crucially, your specific type of cancer cells must have a normal 'TP53' gene. This is something your doctor can check. You also need to be generally well enough to take part, as measured by a health score called ECOG (this usually means you can carry out most daily activities). Your liver, kidney, and blood functions must also be healthy enough.

However, you cannot take part if you have previously been treated with certain types of cancer medicines. This includes any medicine that works like KRT-232 (an MDM2 inhibitor) or any medicine like acalabrutinib (a BTK inhibitor).

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 have Diffuse Large B-Cell Lymphoma or Chronic Lymphocytic Leukaemia?
  3. Has your cancer come back or not responded to previous treatments?
  4. Have you NOT taken an 'MDM2 inhibitor' or 'BTK inhibitor' medication before?
  5. Are you generally well enough for daily activities?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive two study medications, KRT-232 and acalabrutinib. Both of these are taken by mouth. You will have regular appointments at the hospital or clinic, where the study team will monitor your health closely. This will involve physical examinations, blood tests, and scans to see how your body is reacting to the treatment and if your cancer is responding.

The number of visits and tests might be more frequent at the beginning of the study. You will continue to take the medication and have regular check-ups as long as the treatment is helping you and you are not experiencing significant side effects. After you stop taking the study medication, there will be follow-up appointments to monitor your long-term health. The total duration of your participation, including follow-up, will depend on your individual response and how long you remain on treatment.

Potential risks and benefits

Taking part in a study like this might offer a chance to try a new treatment combination that isn't widely available yet, which could potentially help if other treatments haven't worked for you. However, as with any medication, there are potential side effects, and the combination of these two drugs might cause new or different ones. The study team will explain these in detail and monitor you closely for any issues. You are free to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (45)

  • Goshen Center for Cancer Care
    Verified postcode
    Goshen, United States· Recruiting
  • University of Cincinnati
    Verified postcode
    Cincinnati, United States· Recruiting
  • The Ohio State University Comprehensive Cancer Center
    Verified postcode
    Columbus, United States· Recruiting
  • UT Southwestern Medical Center
    Verified postcode
    Dallas, United States· Recruiting
  • Royal Adelaide Hospital
    Verified postcode
    Adelaide, Australia· Recruiting
  • Eastern Health - Box Hill Hospital
    Verified postcode
    Box Hill, Australia· Recruiting
  • Barwon Health
    Verified postcode
    Geelong, Australia· Recruiting
  • Royal Perth Hospital
    Verified postcode
    Perth, Australia· Recruiting
  • Antwerp University Hospital (UZA)
    Verified postcode
    Edegem, Belgium· Recruiting
  • Jessa Ziekenhuis
    Verified postcode
    Hasselt, Belgium· Recruiting
  • University Hospital (UZ) Leuven
    Verified postcode
    Leuven, Belgium· Recruiting
  • Fakultni Nemocnice Hradec Kralove
    Verified postcode
    Nový Hradec Králové, Czechia· Recruiting

Common questions

What kind of cancers is this study for?

This study is for adults with specific types of blood cancer: Diffuse Large B-Cell Lymphoma (DLBCL) or Chronic Lymphocytic Leukaemia (CLL).

What if my cancer has been treated before?

This study is specifically for people whose cancer has returned or didn't respond to previous treatments.

What medicines are being tested?

The study is testing a combination of two medicines called KRT-232 and acalabrutinib.

How do I know if I can join the study?

Your doctor will need to check several things, including your specific cancer type, previous treatments, and general health, to see if you meet the study's requirements.

Will I have to go to the hospital often?

Yes, if you join, you will have regular visits to the clinic or hospital for check-ups, tests, and to get your medication.

How to find out more

John Mei

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 "Safety and Efficacy of KRT-232 in Combination With Acalabrut…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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