RecruitingPHASE3INTERVENTIONAL

To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL

This research study is for people with Peripheral T-Cell Lymphoma (PTCL), a type of blood cancer, who haven't had treatment yet. It's happening in two parts. The first part helps doctors find the safest and most effective dose of two new drug combinations called Bel-CHOP and Fol-COP. These combinations add either Belinostat or Pralatrexate to the existing CHOP or COP treatments. The second part of the study will then compare these new drug combinations against the standard CHOP treatment. The main goal is to see if people taking the new combinations live longer without their cancer getting worse, compared to those on CHOP alone. Patients will receive treatment for up to six cycles.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Acrotech Biopharma Inc.

Enrolment target

504

Start

04 Oct 2023

Estimated completion

01 Nov 2030

Peripheral T Cell Lymphoma

What is this study about?

This study is looking into better ways to treat a type of blood cancer called Peripheral T-Cell Lymphoma (PTCL). PTCL affects certain white blood cells in your body. If you've recently been diagnosed and haven't started treatment yet, this study might be for you. The aim is to see if combining existing treatments with new medicines can be more effective and safe than the current standard treatment.

The study has two main steps. The first step involves a small number of patients and helps doctors work out the best and safest dose of the new drug combinations. Think of it like a test run to make sure they get the settings right before the main event. Once the best doses are found, the study moves on to the second, larger step.

In the second step, more patients will join, and they'll be split into three groups by chance. One group will get the standard treatment called CHOP. The other two groups will receive one of the new combinations (either Bel-CHOP or Fol-COP). Doctors will closely compare how well these different treatments work and if they cause any side effects. The main thing they'll be looking at is how long patients live without their cancer getting worse.

Key takeaways

This study is for newly diagnosed Peripheral T-Cell Lymphoma (PTCL) patients.
It compares new drug combinations with standard treatment.
The first part finds the best dose; the second compares effectiveness and safety.
Treatment will involve up to 6 cycles given every 21 days.
You will be randomly assigned to a treatment group.
Regular check-ups and monitoring will be part of the study.

Who may be eligible?

This study is for adults aged 18 or over who have been newly diagnosed with Peripheral T-Cell Lymphoma (PTCL) and haven't had any treatment for it yet. Your doctor will need to confirm the specific type of PTCL you have.

To be considered, your cancer needs to be measurable, meaning doctors can see and track it. You also need to be generally well enough to take part; this is checked using a standard score called ECOG. Your blood test results, which show how your liver, kidneys, and blood cells are working, also need to be within a certain range.

Some specific types of PTCL are included, but if you have a certain type called ALCL, you're only eligible if a particular drug, Brentuximab Vedotin, isn't usually available in your country, or if you can't take it for medical reasons. Your doctor will be able to check all these details for you.

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.

Have I been newly diagnosed with Peripheral T-Cell Lymphoma (PTCL)?
Have I received no previous treatment for my PTCL?
Am I generally well enough to participate in a clinical study? (Your doctor can check your ECOG score).
Are my blood tests for liver, kidney, and blood cell function within normal limits?
Is my PTCL type one of those included in the study, and is it measurable?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the first stage involves helping doctors find the best dose of the new treatments. If you're in the second stage, you'll be assigned by chance to one of three treatment groups: either the standard CHOP treatment or one of the two new combinations (Bel-CHOP or Fol-COP). You won't be able to choose which group you're in.

For any of the treatments, you'll receive medication through a drip into your vein. This will happen in cycles, typically every 21 days for up to six cycles in total. Throughout the study, you'll have regular hospital visits for check-ups, blood tests, and scans to monitor your health and how the treatment is working. Doctors will also carefully record any side effects you experience. The exact number of visits and tests will depend on your treatment schedule.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to new and innovative treatments that aren't widely available yet, which might be more effective than standard care. However, new treatments also come with potential risks, including unknown side effects or that the new treatment might not work as well as expected. All treatments, including standard ones, carry risks and side effects. You will be closely monitored for any issues. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (69)

University of California, San Francisco Fresno
Verified postcode
Clovis, United States· Recruiting
University of California, Los Angeles Hem/ Onc Clinical Research Unit, Suite 600
Verified postcode
Santa Monica, United States· Recruiting
University of Colorado School of Medicine
Verified postcode
Aurora, United States· Recruiting
Moffitt Malignant Hematology & Cellular Therapy at Memorial Healthcare System Memorial Cancer Institute
Verified postcode
Pembroke Pines, United States· Recruiting
Norton Cancer Institute
Verified postcode
Louisville, United States· Recruiting
Henry Ford Health System
Verified postcode
Detroit, United States· Recruiting
Rutgers Cancer Institute of New Jersey
Verified postcode
New Brunswick, United States· Recruiting
Valley Cancer Associates
Verified postcode
Harlingen, United States· Withdrawn
Houston Methodist Hospital
Verified postcode
Houston, United States· Recruiting
University of Texas, MD Anderson Cancer Center
Verified postcode
Houston, United States· Recruiting
Baylor Scott & White Medical Center - Temple
Verified postcode
Temple, United States· Recruiting
The Ottawa Hospital
Verified postcode
Ottawa, Canada· Recruiting

Common questions

What is Peripheral T-Cell Lymphoma (PTCL)?

PTCL is a type of blood cancer that affects certain white blood cells in your body.

What is the purpose of this study?

The study aims to find out if new drug combinations (Bel-CHOP or Fol-COP) are safer and more effective for PTCL than the current standard treatment (CHOP).

How long will the treatment last?

Patients will receive up to 6 cycles of treatment, with each cycle typically lasting 21 days.

Will I get to choose my treatment?

No, you'll be randomly assigned to one of the treatment groups, meaning you won't choose which treatment you receive.

Can I leave the study at any time?

Yes, you have the right to leave the study at any point, and this won't affect your future medical care.

How to find out more

Uma Srinivas Atmuri, MPharm, MS

uatmuri@acrotechbiopharma.com 732-917-2420 Official trial record

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