Study of Brentuximab Vedotin Combined with R-DHAP Chemotherapy for Patients with Relapsed or Treatment-Resistant CD30-Positive Diffuse Large B-Cell Lymphoma Who Are Eligible for Stem Cell Transplant

2 1 1 1

What is this study about?

This study focuses on patients with non-Hodgkin lymphoma, specifically Diffuse large B-cell lymphoma that is CD30 positive. The study examines a treatment combining Brentuximab Vedotin with a chemotherapy regimen called R-DHAP in patients whose disease has either not responded to initial treatment or has returned after previous therapy.

The purpose of this research is to determine the best dose and effectiveness of combining Brentuximab Vedotin with R-DHAP chemotherapy as a second-line treatment. The study is divided into two parts. The first part will establish the appropriate dose of the medication combination, while the second part will evaluate how well the treatment works.

During the study, participants will receive Brentuximab Vedotin through intravenous administration along with R-DHAP chemotherapy. The treatment will be given in cycles, and patients who respond well to the treatment may proceed to receive high-dose chemotherapy followed by autologous stem cell transplantation (a procedure where a patient’s own stem cells are used for treatment). The total treatment period may last up to 9 months.

1 Initial treatment phase

You will receive a combination treatment called BV-R-DHAP. This includes brentuximab vedotin (BV) together with other medications

The treatment will be given through an intravenous infusion (directly into your vein)

You will receive three treatment cycles in total

2 Treatment monitoring

After each treatment cycle, your blood counts will be monitored to check recovery

Your doctor will evaluate any side effects that may occur

A PET-CT scan (special imaging test) will be performed after the third treatment cycle to check how well the treatment is working

3 Stem cell collection

After the second or third treatment cycle, stem cells will be collected from your blood

These cells will be stored for later use in the transplant

The collection process aims to gather a specific number of cells needed for successful transplant

4 Transplant preparation

If your disease responds to treatment, you will proceed to autologous stem cell transplantation (ASCT)

ASCT uses your own stem cells that were collected earlier

You will receive high-dose chemotherapy before the transplant

5 Post-transplant phase

Your recovery will be monitored after the transplant

Another PET-CT scan will be performed to check the treatment results

You will continue to be monitored for any side effects

6 Follow-up period

Regular check-ups will continue to monitor your health status

Your progress will be tracked until the study ends in February 2027

The medical team will monitor for any long-term effects of the treatment

Who Can Join the Study?

Must be 18 years or older
Must have CD30 positive DLBCL (a type of lymphoma where more than 1% of cells show a specific marker called CD30)
Must be suitable for high-dose chemotherapy and stem cell transplant
Must have either not responded to first treatment or had the disease return after initial R-CHOP therapy (a combination of cancer medicines)
Must have measurable disease showing:
- At least one abnormal area larger than 1.5 cm on CT scan
- At least one positive area on PET scan
Must have a WHO performance status of 0-2 (ability to perform daily activities)
Must have normal liver function
Must have normal kidney function
Must have adequate bone marrow function
Must have hemoglobin level of at least 8 g/dL (blood count can be supported with transfusions)
Must have recovered from side effects of previous treatments
Must have life expectancy of more than 3 months with treatment
Must be able to provide informed consent
For women who can become pregnant:
- Must have negative pregnancy test
- Must use two effective birth control methods or completely avoid heterosexual intercourse during the study and for 12 months after
For men:
- Must use effective barrier contraception or completely avoid heterosexual intercourse during the study and for 12 months after

Who Cannot Join the Study?

History of severe allergic reactions to any of the study medications
Active or chronic hepatitis B (inflammation of the liver caused by hepatitis B virus)
Active hepatitis C infection
Known HIV infection
Serious heart conditions, including:
- Heart failure
- Irregular heartbeat that is not controlled by medication
- Recent heart attack (within 6 months)
Active uncontrolled infections requiring treatment
Other types of cancer that require treatment (except for successfully treated non-melanoma skin cancer or cervical cancer in situ)
Severe kidney problems (creatinine clearance less than 50 mL/min)
Severe liver problems
Nervous system disorders that could interfere with treatment
Pregnancy or breastfeeding
Unable to use effective contraception during the study and for 12 months after
Mental conditions that could affect ability to follow study requirements
Any condition that the study doctor believes would make participation unsafe

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario De Salamanca	Salamanca	Spain
University Hospital Maastricht	Maastricht	The Netherlands

Other Sites

Site Name	City	Country
Haga Hospital	Hague	The Netherlands
Isala Klinieken Stichting	Zwolle	The Netherlands
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Hospital Clinic De Barcelona	Barcelona	Spain
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
St. Antonius Ziekenhuis	Nieuwegein	The Netherlands
Gasthuiszusters Antwerpen	Antwerp	Belgium
Utdewdzweqqq Mldlqaa Cozpuqo Gdgsqgdbp	Groningen	The Netherlands
Iurdntle Ctrghl Dnjckbwgtkmgbgmbk	L'hospitalet De Llobregat	Spain
Arupbqglr Uah	Amsterdam	The Netherlands
Ejplvrx Ugdiustymvoc Meticgo Citafsv Rxutakkvc (qsmxhmv Mfs	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	07.06.2018
Spain	Not recruiting	07.06.2018
The Netherlands	Not recruiting	07.06.2018

Trial locations

Investigated drugs:

Brentuximab Vedotin

Brentuximab Vedotin is a targeted cancer medication that attaches to a protein called CD30 found on some lymphoma cells. It delivers a substance that kills cancer cells. This medication is being studied in combination with other treatments for patients with diffuse large B-cell lymphoma.

R-DHAP is a combination chemotherapy regimen used as a second-line treatment for lymphoma. It consists of rituximab (R) combined with other chemotherapy medications (DHAP) that work together to kill cancer cells. This is commonly used when the first treatment hasn’t worked or when the cancer has returned.

Rituximab is an antibody therapy that targets specific proteins on B-cell lymphoma cells. It helps your immune system identify and destroy these cancer cells. It’s being used as part of the R-DHAP combination therapy in this study.

Investigated diseases:

Non-Hodgkin Lymphoma (NHL) – A group of blood cancers that develop from lymphocytes (white blood cells) in the lymphatic system. It can occur in many different parts of the body, including lymph nodes, spleen, bone marrow, and other organs. The disease develops when lymphocytes begin to multiply abnormally and collect in certain parts of the body. NHL can grow at different rates and can be classified into various subtypes based on how the cells look under a microscope.

Diffuse Large B-cell Lymphoma (DLBCL) – The most common type of non-Hodgkin lymphoma that specifically affects B lymphocytes. It is characterized by large abnormal lymphocytes that have spread diffusely throughout the lymph node or tissue where they are found. The disease typically develops in lymph nodes but can affect other tissues and organs. DLBCL tends to grow quickly in the lymph nodes, causing them to enlarge.

Trial ID:

2023-510556-22-00

Protocol code:

HO136

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study of Brentuximab Vedotin Combined with R-DHAP Chemotherapy for Patients with Relapsed or Treatment-Resistant CD30-Positive Diffuse Large B-Cell Lymphoma Who Are Eligible for Stem Cell Transplant

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?