Isatuximab in Adult Patients With Cytologic or Molecular Relapsed/Refractory CD38 Positive T-cell Acute Lymphoblastic Leukemia
This important study is investigating a drug called Isatuximab for adults aged 18 and over who have T-cell Acute Lymphoblastic Leukemia (T-ALL). This is a type of blood cancer that affects certain white blood cells. The trial is for patients whose cancer has either returned (relapsed) or hasn't responded well to previous treatments (refractory). It's divided into two main groups. One group is for patients with a detectable amount of cancer cells, and the other is for those who are in remission but still have tiny amounts of cancer cells that can be measured (molecular relapse). The aim is to see if Isatuximab can improve how well current treatments work or act as a treatment to prevent the cancer from returning.
At a glance
What is this study about?
This study is a Phase 2 clinical trial looking into a medicine called Isatuximab for adult patients with a specific type of blood cancer: T-cell Acute Lymphoblastic Leukemia, often shortened to T-ALL. This kind of leukemia affects important infection-fighting cells in your body. We know that current treatments for T-ALL can be very effective, but sometimes the cancer comes back or doesn't respond as well as we'd hope. This trial is trying to find better ways to help those patients.
The trial is exploring two different ways Isatuximab might be useful. For some patients, it's being tested when the cancer has clearly returned or isn't responding to treatment. For others, who are in remission but where very small amounts of cancer cells can still be detected (this is called 'molecular failure' or 'molecular relapse'), the study is trying to see if Isatuximab can help get rid of these tiny amounts and prevent the cancer from coming back.
Essentially, the researchers want to see if adding Isatuximab can make current treatments more effective or provide a new treatment option for patients where the cancer has returned or if it can act as a 'clean-up' treatment to prevent future relapses. This is a common and important step in developing new cancer treatments.
Key takeaways
- This study is for adults with T-ALL that is relapsed or refractory.
- It's testing a drug called Isatuximab, which targets cancer cells.
- The study considers two groups: those with clear cancer activity and those with tiny traces of cancer (MRD+).
- It aims to see if Isatuximab can improve treatment or prevent cancer from coming back.
- Participants must be at least 18 years old and generally well enough for the study.
Who may be eligible?
To be considered for this study, you must be at least 18 years old and have been diagnosed with CD38 positive T-cell Acute Lymphoblastic Leukemia (T-ALL). Your health, overall, needs to be reasonably good; for most patients, this means you can perform most daily activities and only have minor restrictions.
The study is split into two main groups based on your current health situation. The first group is for patients whose T-ALL has unfortunately come back (relapsed) or hasn't responded well to previous treatments. This means your bone marrow still shows a certain amount of cancer cells. This could be if your cancer returned within a year or later after getting better, if it never fully responded, or if it came back after a stem cell transplant.
The second group is for patients who are currently in remission, meaning visible signs of cancer have largely gone, but sensitive tests still show tiny traces of cancer cells (called 'minimal residual disease' or MRD). For this group, you must show no clear signs of cancer in your bone marrow or other parts of your body, but the special blood tests confirm those very small amounts are still present and have been for at least two weeks since your last chemotherapy.
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.
- Are you 18 years old or older?
- Do you have CD38 positive T-cell Acute Lymphoblastic Leukemia (T-ALL)?
- Has your T-ALL either come back/not responded well to treatment, OR are you in remission but still have tiny traces of cancer (MRD positive)?
- Are you generally able to carry out most daily activities?
- Are you able to attend study visits and follow the treatment plan?
What does participation involve?
If you decide to take part in this study, you'll need to sign a consent form, showing you understand what's involved. You'll also need to commit to attending all scheduled appointments, which will involve regular visits to the clinic for assessments. These assessments will include blood tests and possibly bone marrow samples to check how you're responding to the treatment and for safety. You'll receive the study drug, Isatuximab, according to a specific plan outlined by the researchers.
Throughout the study, the medical team will carefully monitor your health and any side effects you might experience. It's important that you're willing and able to follow the treatment schedule and procedures. The total length of your participation would depend on your response to treatment and the study's specific design, but you will be informed about the expected duration at the outset.
Potential risks and benefits
Locations (14)
- University Hospital Augsburg, II. Medizinischen Klinik, Hämatologie, internistische Onkologie und HämostaseologieVerified postcodeAugsburg, Germany· Recruiting
- Charité Berlin, Campus Benjamin Franklin, Department of Hematology, Oncology and Tumorimmunologyt HämatologieVerified postcodeBerlin, Germany· Recruiting
- Klinikum Carl Gustav Carus Dresden, Medizinische Klinik und Poliklinik IVerified postcodeDresden, Germany· Recruiting
- University Hospital Düsseldorf, Department of Hematology, Oncology and Clinical ImmunologyVerified postcodeDüsseldorf, Germany· Recruiting
- University Hospital Erlangen AöR, Department of Medicine 5Verified postcodeErlangen, Germany· Recruiting
- Goethe University Hospital Frankfurt, Department of Medicine, Hematology and OncologyVerified postcodeFrankfurt am Main, Germany· Recruiting
- University Hospital Hamburg-Eppendorf, Department of Medicine IIVerified postcodeHamburg, Germany· Recruiting
- University Hospital Heidelberg, Department V, Hematology, Oncology and RheumatologyVerified postcodeHeidelberg, Germany· Recruiting
- University Hospital Schleswig-Holstein, Campus Kiel, Medical Department IIVerified postcodeKiel, Germany· Recruiting
- University Hospital Leipzig; Klinik für Hämatologie, Zelltherapie, Hämostaseologie und Infektiologie, Bereich Hämatologie und ZelltherapieVerified postcodeLeipzig, Germany· Recruiting
- University Hospital München-Großhadern, Medizinische Klinik und Poliklinik IIIVerified postcodeMünchen, Germany· Recruiting
- University Hospital Münster, Medizinische Klinik A / KMT-ZentrumVerified postcodeMünster, Germany· Recruiting
Common questions
What is T-cell Acute Lymphoblastic Leukemia (T-ALL)?
It's a fast-growing cancer of the blood and bone marrow, affecting a type of white blood cell called T-lymphocytes.
What does 'relapsed/refractory' mean?
It means the cancer has come back after treatment (relapsed) or it hasn't responded well to previous treatments (refractory).
What is Isatuximab?
It's a type of drug that works by targeting specific proteins on cancer cells, helping the body's immune system to attack them.
What is 'MRD positive'?
MRD stands for Minimal Residual Disease. Being 'MRD positive' means that even if you're in remission, very sensitive tests can still detect tiny amounts of cancer cells.
Will I get this drug if I join the study?
Yes, if you meet the eligibility criteria, you would receive Isatuximab as part of the study treatment plan.
How to find out more
Nicola Goekbuget, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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