Study Comparing Polatuzumab Vedotin with Rituximab, Ifosfamide, Carboplatin, and Etoposide for Adults with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called Diffuse Large B-Cell Lymphoma (DLBCL), which is a form of non-Hodgkin lymphoma. The study is investigating a treatment approach for patients whose DLBCL has either returned after treatment or did not respond to initial treatment. The treatment being tested combines several medications: Polatuzumab vedotin, Rituximab, Ifosfamide, Carboplatin, and Etoposide. These medications are given together in a regimen known as Pola-R-ICE. The study aims to compare the effectiveness of this combination with a similar regimen that does not include Polatuzumab vedotin, known as R-ICE.

The purpose of the study is to determine if adding Polatuzumab vedotin to the R-ICE regimen improves the time patients remain free from cancer events, which is referred to as event-free survival. Participants in the study will receive the treatment through an intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein. The study will follow participants over a period to monitor their response to the treatment and any side effects they may experience.

Throughout the study, researchers will collect information on various outcomes, such as how long patients remain free from cancer progression, the overall response to the treatment, and any side effects. The study will also look at the quality of life of participants during and after treatment. This research is important for understanding whether the addition of Polatuzumab vedotin can provide better outcomes for patients with relapsed or refractory DLBCL compared to the standard R-ICE treatment alone.

1 joining the study

Upon joining the study, the patient will be informed about the trial and will sign a consent form. This step ensures understanding and agreement to participate in the study.

2 initial assessment

The patient will undergo an initial assessment to confirm eligibility. This includes a review of medical history, a physical examination, and necessary laboratory tests.

3 treatment phase

The treatment phase involves receiving medications through intravenous infusion. The medications include polatuzumab vedotin, rituximab, ifosfamide, carboplatin, and etoposide.

The treatment is administered in cycles. Each cycle lasts for a specific period, followed by a rest period. The exact duration and frequency of the cycles will be explained by the healthcare provider.

4 monitoring and follow-up

Throughout the study, the patient’s health and response to treatment will be closely monitored. This includes regular check-ups, blood tests, and imaging studies to assess the effectiveness of the treatment.

The patient will be observed for any side effects or adverse reactions to the medications.

5 end of treatment evaluation

At the end of the treatment phase, a comprehensive evaluation will be conducted to determine the patient’s response to the therapy.

This evaluation will include a final set of tests and assessments to measure the outcomes of the treatment.

6 long-term follow-up

After completing the study, the patient may be asked to participate in long-term follow-up visits. These visits help in understanding the long-term effects and benefits of the treatment.

Who Can Join the Study?

The informed consent form must be signed before any study-specific tests or procedures are done. This means you agree to participate and understand what the study involves.
Have adequate blood function, which means:
- Hemoglobin (a protein in red blood cells) should be at least 8 g/dL. If low due to the disease, it should increase to at least 8 g/dL with transfusions.
- Absolute neutrophil count (ANC), a type of white blood cell, should be at least 1.0 x 10⁹/L, or at least 0.5 x 10⁹/L if low due to the disease and before taking steroids.
- Platelet count, which helps with blood clotting, should be at least 75 x 10⁹/L, or at least 50 x 10⁹/L if low due to the disease.
Women who can have children must have a negative pregnancy test within 7 days before starting the study medication.
Women who can have children must agree to either not have heterosexual intercourse or use birth control, and agree not to donate eggs.
Men must agree to either not have heterosexual intercourse or use birth control, and agree not to donate sperm.
Be an adult male or female, at least 18 years old (or 16 years old in the UK).
Be able to understand and follow instructions related to the study.
Belong to a risk group with specific types of aggressive B-cell non-Hodgkin lymphoma, confirmed by a biopsy. This includes:
- DLBCL not otherwise specified (NOS)
- T-cell/histiocyte-rich large B-cell lymphoma
- Primary cutaneous DLBCL, leg type
- Epstein-Barr virus (EBV)-positive DLBCL, NOS
- DLBCL associated with chronic inflammation
- Primary mediastinal (thymic) large B-cell lymphoma
- High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
- High-grade B-cell lymphoma, NOS
Have a Performance Status of ECOG 0-2 at the time of randomization, or ECOG 3 at screening if it is related to DLBCL and improves to ECOG 2 or less with a 7-day steroid treatment during screening. ECOG is a scale to assess how the disease affects daily living abilities.
Provide information on all 5 International Prognostic Index (IPI) factors, which help predict the outcome of the disease.
Have staging done using PET-CT based on Lugano criteria 2014, with PET-positive lesions. This is a way to see how far the disease has spread.
Must have received adequate first-line therapy, including:
- An anti-CD20 monoclonal antibody, unless the tumor is CD20 negative.
- A chemotherapy regimen containing anthracycline, a type of cancer drug.
Have the intent to proceed to high-dose therapy (HDT) and stem cell transplantation (SCT) if there is a response to second-line therapy.

Who Cannot Join the Study?

Patients who are not adults cannot participate. This means only individuals who are 18 years or older are eligible.
Patients who do not have a type of cancer called DLBCL (Diffuse Large B-Cell Lymphoma) that has either come back after treatment or has not responded to treatment cannot participate.
Patients who are not able to understand or agree to the study requirements cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have other serious health conditions that might interfere with the study cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have had certain treatments recently that might affect the study cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medical University Of Vienna	Vienna	Austria
University Hospital Jena KöR	Jena	Germany
Universitaetsmedizin Goettingen	Goettingen	Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Hospital Universitario De Salamanca	Salamanca	Spain
Rostock University Medical Center	Rostock	Germany
Medical University Of Graz	Graz	Austria
Technische Universitaet Dresden	Dresden	Germany
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Klinikum Oldenburg AöR	Oldenburg In Holstein	Germany
Staedtisches Klinikum Braunschweig gGmbH	Brunswick	Germany
Universitaetsklinikum Aachen AöR	Aachen	Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH	Ludwigshafen Am Rhein	Germany
Hospital Universitario 12 De Octubre	Madrid	Spain
Klinikum Wels-Grieskirchen GmbH	Wels	Austria
SCRI CCCIT Ges.m.b.H.	Salzburg	Austria
El Hospital Universitario De Gran Canaria Dr. Negrin	Las Palmas De Gran Canaria	Spain
HELIOS Klinikum Berlin-Buch GmbH	Berlin	Germany
Virgen del Rocío University Hospital	Sevilla	Spain
Klinikum Der Landeshauptstadt Stuttgart gKAöR	Stuttgart	Germany
Hospital Clinic De Barcelona	Barcelona	Spain
Universitaetsklinikum Magdeburg AöR	Magdeburg	Germany
Philipps-Universitaet Marburg	Marburg	Germany
Marien Hospital Duesseldorf GmbH	Duesseldorf	Germany
Westpfalz-Klinikum GmbH	Kaiserslautern	Germany
Klinikum Chemnitz gGmbH	Chemnitz	Germany
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse	Vienna	Austria
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Helios Universitaetsklinikum Wuppertal	Wuppertal	Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Servei De Salut De Les Illes Balears	Palma	Spain
Uktpvhehcr Mxrrzsh Caozdh Hegidutokbnfeayio	Hamburg	Germany
Opckpjjtfrzbts Lkdl Gjwr	Linz	Austria
Hdkftorb Ubpqjgzkvwpgz Mneguun Dq Vinnqgmgmi	Santander	Spain
Iyhsmqje Cggxqs Dnocfhcpsdwecotay	L'hospitalet De Llobregat	Spain
Crnwgggd Huxyoanngkmm Urvtrmcrkenjs Da Vivp	Vigo	Spain
Ucobxrfyjinkbxlpqmqsv Mrbhwgse Anp	Munster	Germany
Hsqxjrzh Utquaihiabudx Dcpntsqv	Donostia / San Sebastian	Spain
Gmbuon Ucqjjlqiee Frhitivzc	Frankfurt	Germany
Fwegudlex Psaf Lc Ibmxouyqalhrd Bpuphdkim Dsz Hyjxjhyd Ugrkhulxpoufk La Pyr	Madrid	Spain
Jwaoemes Ksesqb Ujwckrkxvm	Linz	Austria
Hasjvtpq Vvqx dpxkcwrc	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	30.04.2021
Germany	Not recruiting	30.04.2021
Spain	Not recruiting	30.04.2021

Trial locations

Investigated drugs:

Polatuzumab Vedotin is a medication used in this trial as part of a combination therapy. It is an antibody-drug conjugate that targets cancer cells, specifically in patients with diffuse large B-cell lymphoma (DLBCL). It works by delivering a toxic substance directly to the cancer cells, helping to destroy them while minimizing damage to normal cells.

Rituximab is a medication that is part of the combination therapy used in this trial. It is a monoclonal antibody that targets a specific protein on the surface of certain cancer cells. By binding to this protein, rituximab helps the immune system to identify and destroy these cancer cells.

Ifosfamide is a chemotherapy drug included in the treatment regimen. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing. This helps to slow down or stop the progression of the cancer.

Carboplatin is another chemotherapy medication used in the trial. It damages the DNA of cancer cells, which can lead to cell death. This helps to reduce the number of cancer cells in the body and slow the spread of the disease.

Etoposide is a chemotherapy drug that is part of the treatment combination. It works by inhibiting an enzyme that is necessary for cancer cells to divide and grow. By doing so, etoposide helps to stop the proliferation of cancer cells.

Diffuse Large B-Cell Lymphoma (DLBCL) – This is a type of non-Hodgkin lymphoma, which is a cancer that originates in the lymphatic system. DLBCL is characterized by the rapid growth of large B-cells in the lymph nodes, spleen, liver, bone marrow, or other organs. It often presents as a rapidly enlarging mass, typically in the neck, abdomen, or mediastinum. The disease can progress quickly, requiring prompt medical attention. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. DLBCL can be classified as relapsed or refractory when it does not respond to initial treatment or returns after treatment.

Trial ID:

2023-508259-38-00

Protocol code:

MO40599/GLA 2017-R2

NCT ID:

NCT04833114

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Polatuzumab Vedotin with Rituximab, Ifosfamide, Carboplatin, and Etoposide for Adults with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?