Study on Brentuximab Vedotin and Drug Combination for Patients with Peripheral T-cell Lymphoma with Less Than 10% CD30 Expression

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What is this study about?

This clinical trial is focused on studying a type of cancer called Peripheral T-cell Lymphoma (PTCL). The study is investigating a treatment combination that includes several medications: Brentuximab Vedotin, Doxorubicin Hydrochloride, Cyclophosphamide, and Prednisone. These medications are used to treat cancer by targeting and killing cancer cells. The purpose of the study is to evaluate how well this combination works in treating PTCL, especially in cases where the cancer cells have less than 10% of a protein called CD30.

Participants in the study will receive the treatment over a period of six months. The treatment involves receiving the medications through an intravenous infusion, which means the drugs are given directly into a vein, and in the case of prednisone, it is taken orally as a tablet. The study is designed to observe the response of the cancer to the treatment and to monitor any side effects that may occur. The study will also look at how long the treatment keeps the cancer from getting worse and the overall survival of the participants.

The study is open-label, meaning both the researchers and participants know which treatment is being given. It is divided into two groups, or cohorts, to better understand the effects of the treatment. The results will be reviewed by independent experts to ensure accuracy. This study aims to provide valuable information on the effectiveness of this treatment combination for people with PTCL, potentially leading to improved treatment options in the future.

1 initial visit

Upon joining the study, you will have an initial visit with the medical team. During this visit, you will receive detailed information about the study, including the treatment plan and schedule.

You will be asked to provide written consent to participate in the study. If you are unable to provide consent, a legally authorized representative may do so on your behalf.

2 treatment cycle 1

The treatment involves a combination of medications administered in cycles. Each cycle lasts for a specific period, followed by a rest period.

You will receive doxorubicin hydrochloride and cyclophosphamide through an intravenous infusion. This means the medication will be given directly into your vein.

You will also receive brentuximab vedotin through intravenous administration.

Additionally, you will take prednisone tablets orally. The dosage and frequency will be determined by your medical team.

3 subsequent treatment cycles

You will continue to receive the same combination of medications in subsequent cycles. The number of cycles will be determined by your medical team based on your response to the treatment.

Regular monitoring and assessments will be conducted to evaluate your progress and adjust the treatment plan if necessary.

4 follow-up visits

After completing the treatment cycles, you will have follow-up visits with the medical team. These visits are important to monitor your health and the effectiveness of the treatment.

During these visits, additional tests and assessments may be conducted to ensure your well-being.

Who Can Join the Study?

Must be 18 years or older.
Must have a type of cancer called Peripheral T-cell Lymphoma (PTCL), but not a subtype called sALCL.
Must have one of the following PTCL subtypes:
- PTCL – not otherwise specified (PTCL-NOS)
- Angioimmunoblastic T-cell lymphoma (AITL)
- Adult T-cell leukemia/lymphoma (ATLL; acute and lymphoma types only, must be positive for human T cell leukemia virus 1)
- Enteropathy-associated T-cell lymphoma (EATL)
- Hepatosplenic T-cell lymphoma
- Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITCL)
- Indolent T-cell lymphoproliferative disorder (T-LPD) of the gastrointestinal (GI) tract
- Follicular T-cell lymphoma
- Nodal PTCL with T-follicular helper (TFH) phenotype
Must have CD30 expression less than 10% in a tumor sample.
Must have a type of disease that shows up on a scan called PET and can be measured by a CT scan to be at least 1.5 cm.
Must have an ECOG performance status of 2 or less, which means you are able to carry out all self-care but unable to carry out any work activities.
Must have certain blood test results within specific limits:
- Bilirubin level 1.5 times the upper limit of normal or 3 times for those with Gilbert’s disease or liver involvement with lymphoma.
- ALT and AST levels 3 times the upper limit of normal or 5 times for those with liver involvement with lymphoma.
- Serum creatinine level 2 times the upper limit of normal.
- Estimated glomerular filtration rate (eGFR) greater than 45 mL/min/1.73 m².
- Absolute neutrophil count (ANC) of at least 1000/µL unless there is bone marrow involvement with lymphoma.
- Platelet count of at least 50,000/µL unless there is bone marrow involvement with lymphoma.
If HIV-positive, must meet these conditions:
- CD4+ T-cell count of at least 350 cells/µL within 28 days of starting the study.
- No AIDS-defining infections in the past 12 months.
- On stable HIV treatment for at least 4 weeks with a viral load less than 400 copies/mL within 28 days of starting the study.
Males with partners who can become pregnant must agree to use effective birth control during the study and for a certain period after the last dose of treatment.
Females who can become pregnant must have a negative pregnancy test before starting the study and agree to use effective birth control during the study and for a certain period after the last dose of treatment.
Must provide written informed consent to participate in the study. If unable to provide consent, a legally authorized representative can do so, but the participant must provide consent later if able.

Who Cannot Join the Study?

Patients with any other type of cancer besides Peripheral T-cell Lymphoma cannot participate.
Patients who have had another cancer within the last 5 years, except for skin cancer that is not melanoma, cannot participate.
Patients who have received any other treatment for cancer within the last 4 weeks cannot participate.
Patients with uncontrolled or serious infections cannot participate.
Patients with significant heart problems cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have a known allergy to the study medication cannot participate.
Patients who have participated in another clinical trial within the last 4 weeks cannot participate.
Patients with any condition that the study doctors believe would make it unsafe for them to participate cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario De Salamanca	Salamanca	Spain
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hospital Universitario 12 De Octubre	Madrid	Spain
MD Anderson Cancer Center	Madrid	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Universita’ Degli Studi Di Verona	Verona	Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace	Mulhouse	France
Universita Degli Studi Di Brescia	Brescia	Italy
Hospital Costa del Sol	Marbella	Spain
Idlfxjde Cinrvj Dgmzehjovlzrjctvl	L'hospitalet De Llobregat	Spain
Agakbfc Unwny Skdctcajl Ltlajj Dk Bwamknj	Bologna	Italy
Hxhifgwu Dh Lh Sziiu Cqym I Sraz Phx	Barcelona	Spain
Falgmulie Posc Lo Izmlxuhwhykxc Bjbrlpgvg Dok Hsyxfkdz Ueezxnkpykatu Lt Pnf	Madrid	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	28.07.2021
Italy	Not recruiting	28.07.2021
Spain	Not recruiting	28.07.2021

Trial locations

Investigated drugs:

Brentuximab Vedotin is a type of medication used in cancer treatment. It works by attaching to a specific protein found on the surface of some cancer cells. Once attached, it releases a substance that helps to kill these cancer cells. In this trial, it is being used to treat a type of cancer called peripheral T-cell lymphoma.

CHP is a combination of three different chemotherapy drugs used together to treat cancer. These drugs work by stopping the growth of cancer cells, which helps to shrink tumors and slow down the progression of the disease. In this trial, CHP is used alongside brentuximab vedotin to treat peripheral T-cell lymphoma.

Peripheral T-cell Lymphoma – Peripheral T-cell Lymphoma is a type of non-Hodgkin lymphoma that originates from mature T-cells. It involves the abnormal growth of T-cells, which are a type of white blood cell crucial for the immune response. The disease often presents with symptoms such as swollen lymph nodes, fever, and weight loss. As it progresses, it can affect various parts of the body, including the skin, liver, and bone marrow. The disease is characterized by its aggressive nature and can vary significantly in its presentation and progression. It is known for its diverse subtypes, each with unique clinical features.

Trial ID:

2023-509155-14-00

Protocol code:

C5691004 / SGN35-032

NCT ID:

NCT04569032

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Brentuximab Vedotin and Drug Combination for Patients with Peripheral T-cell Lymphoma with Less Than 10% CD30 Expression

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?