RecruitingPHASE2, PHASE3INTERVENTIONAL

Therapy Optimisation for the Treatment of Hairy Cell Leukemia

This study is looking at a new way to give a treatment called cladribine for people with hairy cell leukemia. Instead of an IV drip, it's given as an injection just under the skin. We want to see how effective this method is at treating the leukemia and if it causes any side effects. This trial is for adult patients who have recently been diagnosed with hairy cell leukemia and haven't had much treatment before, or only early interferon therapy. Doctors will check how well the treatment worked four months later. If the leukemia hasn't responded as well as hoped, some patients might receive a second round of the medicine. The goal is to find the best way to use cladribine to help patients with this rare type of blood cancer.

At a glance

Status

Recruiting

Phase

PHASE2, PHASE3

Sponsor

University of Giessen

Enrolment target

210

Start

01 May 2004

Estimated completion

01 Dec 2027

Hairy Cell Leukemia

What is this study about?

This clinical trial is designed to investigate a treatment called cladribine for a rare type of blood cancer called hairy cell leukemia. Currently, cladribine is a well-known and effective treatment for this condition. However, it's usually given through a drip into a vein. This study is exploring a different approach: giving cladribine as an injection just under the skin (subcutaneously). This could potentially make the treatment easier and more convenient for patients.

The main goals of this study are to see how effective this new injection method is at getting rid of the leukemia cells and to identify any side effects that might occur. The researchers will be closely monitoring patients and checking their progress, particularly four months after the main treatment. By doing this, they hope to improve how cladribine is given and ensure patients get the best possible care.

The study also aims to understand what happens if the first round of treatment doesn't fully clear the leukemia. For some patients, if there are still signs of the disease or if they don't achieve full remission, the study will test if a second round of cladribine injections would be beneficial. This approach helps doctors fine-tune treatment plans, ensuring that patients with hairy cell leukemia receive the most appropriate and effective care tailored to their individual response.

Key takeaways

This study evaluates cladribine for hairy cell leukemia given as an injection under the skin.
It's for adults with newly diagnosed or minimally pre-treated hairy cell leukemia.
The study assesses how well the treatment works and any side effects.
Potential for a second round of injections if the first response isn't optimal.
Participation involves one or possibly two cycles of injections and follow-up checks.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) with hairy cell leukemia that has been confirmed by medical tests. Your general health should be good enough to take part, as assessed by the research team. Crucially, you should not have had much treatment for hairy cell leukemia before, although some early treatments like Interferon or removal of your spleen are usually fine.

There are also some reasons why you wouldn't be able to join. For example, if your hairy cell leukemia is a different, very rare type called 'hairy cell leukemia variant'. You also can't have had certain strong chemotherapy drugs in the past or be taking specific steroid medications concurrently. The study also cannot include pregnant or breastfeeding women. Additionally, if you have severe heart, lung, liver, or kidney problems, certain infections like HIV or active Hepatitis, or another serious cancer, you would not be eligible to participate.

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?
Have you been diagnosed with hairy cell leukemia?
Have you had no previous strong chemotherapy for hairy cell leukemia (interferon allowed)?
Are you generally in good health, without severe heart, lung, liver, or kidney problems?
Are you not pregnant or breastfeeding?
Do you not have an active HIV infection or Hepatitis?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll receive a type of chemotherapy called cladribine as an injection under your skin. The main treatment will involve one cycle of these injections. Approximately four months after this treatment, doctors will thoroughly check your health and how well the treatment has worked. This will likely involve blood tests and possibly a bone marrow check. If the leukemia hasn't responded as perfectly as hoped, you might be offered a second cycle of the cladribine injections. The total time you'll be actively involved in assessments and receiving treatment will depend on your response, but the main evaluation is at four months.

Potential risks and benefits

Taking part in this study could offer you the benefit of receiving a standard, effective treatment (cladribine) for hairy cell leukemia in a potentially more convenient way (subcutaneous injection). Researchers will closely monitor your health, providing thorough care. However, all medical treatments carry risks. Cladribine can cause side effects, including a weakened immune system, tiredness, and potential effects on blood counts. The research team will explain all known side effects in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (76)

Community based hemato-oncology medical office
Verified postcode
Ansbach, Germany· Recruiting
Community based hemato-oncology medical office
Verified postcode
Aschaffenburg, Germany· Recruiting
Rhön-Saale-Klinik gGmbH
Verified postcode
Bad Neustadt an der Saale, Germany· Recruiting
Community based hemato-oncology medical office
Verified postcode
Berlin, Germany· Recruiting
Charité - Universitätsmedizin Berlin
Verified postcode
Berlin, Germany· Recruiting
Community based hemato-oncology medical office
Verified postcode
Bremen, Germany· Recruiting
Community based hemato-oncology medical office
Verified postcode
Celle, Germany· Recruiting
Community based hemato-oncology medical office
Verified postcode
Cottbus, Germany· Recruiting
Community based hemato-oncology medical office
Verified postcode
Darmstadt, Germany· Recruiting
Community based hemato-oncology medical office
Verified postcode
Dresden, Germany· Recruiting
Community based hemato-oncology medical office
Verified postcode
Duisburg, Germany· Recruiting
Klinik Duisburg-West
Verified postcode
Duisburg, Germany· Recruiting

Common questions

What is hairy cell leukemia?

It's a rare type of cancer that affects your blood and bone marrow, where your body makes blood cells.

What is cladribine?

Cladribine is a medicine used to treat hairy cell leukemia, often given through a drip, but this study is testing it as a simple injection.

Why are they giving it as an injection instead of a drip?

The study wants to see if giving it as an injection under the skin is just as effective and perhaps more convenient for patients than an IV drip.

What happens if the first treatment doesn't work perfectly?

The study will also look at whether a second round of the cladribine injections helps if the first treatment didn't fully clear the leukemia.

Can I stop being in the study if I change my mind?

Yes, you can choose to leave the study at any time, and it won't affect your medical care.

How to find out more

Mathias J Rummel, Prof PhD

mathias.rummel@innere.med.uni-giessen.de +4964198542 Official trial record

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