Study on Acalabrutinib with Rituximab and Drug Combination for Older Adults with Untreated Diffuse Large B-Cell Lymphoma

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What is this study about?

This clinical trial is focused on studying the effectiveness of a treatment for , a type of cancer that affects the white blood cells. The study involves a combination of medications, including , , and a reduced dose of a chemotherapy regimen known as R-miniCHOP. R-miniCHOP includes several drugs: , , , , and . The purpose of the study is to determine if adding acalabrutinib to the R-miniCHOP treatment can help patients live longer without the disease getting worse, compared to using R-miniCHOP alone.

Participants in the study will receive either the combination of acalabrutinib with R-miniCHOP or R-miniCHOP alone. The study is designed for older adults who have not been treated for DLBCL before. The treatment will be administered over a period of time, with regular check-ups to monitor the patient’s health and the progression of the disease. Some patients may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatment.

The study aims to provide valuable information on whether the addition of acalabrutinib can improve outcomes for patients with DLBCL. The results will help doctors understand if this combination of treatments is more effective than the standard R-miniCHOP therapy. This research is important for developing better treatment options for patients with this type of lymphoma.

1 joining the study

Upon joining the study, you will be randomly assigned to one of two groups. One group will receive the combination of acalabrutinib with R-miniCHOP, and the other group will receive R-miniCHOP alone. This is to compare the effectiveness of the treatments.

2 treatment phase

During the treatment phase, you will receive a combination of medications. These include doxorubicin, prednisone, cyclophosphamide, acalabrutinib, rituximab, vincristine sulfate, prednisolone, and pegfilgrastim. The medications will be administered either orally or through an intravenous (IV) line, depending on the specific drug.

The treatment is given in cycles. Each cycle lasts for a specific period, and the exact duration and frequency of each medication will be explained to you by the medical team. It is important to follow the schedule provided to ensure the best possible outcome.

3 monitoring and assessments

Throughout the trial, regular monitoring and assessments will be conducted to evaluate your response to the treatment. This includes physical examinations, blood tests, and imaging studies. These assessments help in understanding how the treatment is affecting your condition and in making any necessary adjustments.

4 end of treatment

At the end of the treatment phase, a final set of assessments will be conducted to determine the overall response to the therapy. This will include evaluating the progression of the disease and any side effects experienced during the trial.

5 follow-up

After completing the treatment, follow-up visits will be scheduled to monitor your health and any long-term effects of the treatment. These visits are crucial for ensuring your well-being and for gathering data on the long-term effectiveness of the treatment.

Who Can Join the Study?

  • Ability to understand the purpose and risks of the study and capable of giving signed informed consent.
  • Meet specific laboratory test results:
    • Absolute neutrophil count (ANC) of at least 1500 cells/µl or platelet count of at least 100,000/µl, unless the lymphoma is causing lower counts.
    • Serum AST and ALT levels no more than 3 times the upper limit of normal, unless the lymphoma is causing higher levels.
    • Total bilirubin no more than 1.5 times the upper limit of normal, unless due to Gilbert’s syndrome or lymphoma.
    • Estimated creatinine clearance of at least 30 mL/min, or serum creatinine no more than 2.5 times the upper limit of normal.
  • Provide signed and dated written consent before any study-specific procedures.
  • Willing and able to participate in all required evaluations and procedures, including swallowing capsules and tablets without difficulty.
  • Men and women over 80 years old, or over 60 up to 80 years old and not eligible for full-dose R-CHOP treatment.
  • Sexually active male patients must agree to use highly effective contraception with a condom during the study.
  • Sexually active female patients must agree to use highly effective contraception during the study.
  • Have a confirmed diagnosis of CD20+ diffuse large B-cell lymphoma (DLBCL) or related types, as specified in the study.
  • Disease stage I with a large tumor (at least 7.5 cm), or stage II, III, or IV according to the Ann Arbor Classification.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. A score of 3 is acceptable only if it is directly due to lymphoma.

Who Cannot Join the Study?

  • Patients with any other type of cancer that is not one of the specific types of large B-cell lymphoma listed in the study.
  • Patients who have already received treatment for diffuse large B-cell lymphoma (DLBCL).
  • Patients who are younger than 60 years old and are eligible for full-dose R-CHOP treatment.
  • Patients who are unable to take the study medication due to allergies or other medical reasons.
  • Patients who are pregnant or breastfeeding.
  • Patients with severe heart problems or uncontrolled medical conditions.
  • Patients who have an active infection that requires treatment.
  • Patients who have a history of other serious diseases that might interfere with the study.
  • Patients who are participating in another clinical trial at the same time.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Klinikum Der Landeshauptstadt Stuttgart gKAöR Stuttgart Germany
Universitaetsklinikum Aachen AöR Aachen Germany
Klinikum St Marien Amberg Amberg Germany
Klinikum Esslingen GmbH Esslingen Am Neckar Germany
Kliniken Suedostbayern AG Traunstein Germany
Medizinisches Versorgungszentrum des Bruederkrankenhauses St. Josef Paderborn gGmbH Paderborn Germany
Klinikum Frankfurt (Oder) GmbH Frankfurt (oder) Germany
Klinikum Nuernberg Nürnberg Germany
Caritas Traegergesellschaft Saarbruecken mbH (CTS) Saarbrücken Germany
Gesellschaft Zur Forderung Des Wissenschaftlich Medizinischen Erkenntnisgewinns In Der Hamatologie Und Oncologie Munster Germany
University General Hospital Of Ioannina Ioannina Greece
SLK-Kliniken Heilbronn GmbH Heilbronn Germany
Klinikum Suedstadt Rostock Rostock Germany
Saarland University Hospital Homburg Germany
Westpfalz-Klinikum GmbH Kaiserslautern Germany
Klinikum Chemnitz gGmbH Chemnitz Germany
Vincentius-Diakonissen-Kliniken gAG Karlsruhe Germany
Diako Ev. Diakonie-Krankenhaus gGmbH Bremen Germany
Kliniken der Stadt Koeln gGmbH Cologne Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
General University Hospital Of Patras Patras Greece
Justus-Liebig-Universitaet Giessen Giessen Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Staedtisches Klinikum Karlsruhe gGmbH Karlsruhe Germany
Barmherzige Brueder Trier gGmbH Trier Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Klinikum Mutterhaus der Borromaeerinnen gGmbH Trier Germany
Klinikum Magdeburg gGmbH Magdeburg Germany
Rheinland Klinikum Neuss GmbH Neuss Germany
HELIOS Klinikum Emil von Behring GmbH Berlin Germany
Diakonie in Suedwestfalen gGmbH Siegen Germany
Sozialstiftung Bamberg Medizinisches Versorgungszentrum am Bruderwald gGmbH Bamberg Germany
Muehlenkreiskliniken AöR Minden Germany
Petrus-Krankenhaus Wuppertal Germany
OncoResearch Lerchenfeld GmbH Hamburg Germany
Bundeswehrkrankenhaus Ulm Ulm Germany
Klinikum Barnim GmbH Werner Forbmann Krankenhaus Eberswalde Germany
Onkologische Schwerpunktpraxis Kurfuerstendamm Berlin Germany
University Hospital of Alexandroupolis Alexandroupoli Greece
Uknvgwftwdnjguinpodco Efzpl Agn Essen Germany
Mnfouohauarotyvup Kezpjtgv Sxn Evgfjiyfo Saarlouis Germany
Tdlgnbcmau Cqrkvg Hfhzklmy Thessaloniki Greece
Lbgvl Gxgmsdu Hxzxyrij Od Azpvco Athens Greece
Kbxfyuvw Ruuxib Rheine Germany
Sgp Bzgmvyof Kdsfyhfbhoq Gzbr Hildesheim Germany
Cvzzdrw fue Hgzhznbtiir uuj Ofejriafc ay Bgsebxodqkqthugtwrbfs Frankfurt Germany
Pbkivjyj Wwsydopkr Wolfsburg Germany
Ubfpwadmlqowjkcbccaqk Mnlyovhv Avq Munster Germany
Kfvmwpwh Bultwhpe Grzq Bayreuth Germany
Kwmwuywg dbl Ufydpxsjrkrp Mdpyolvf Ajs Munich Germany
Mjsncggzcgvxgvcoqcvtyusach Hxuqrgsyravrgdqt Halle (Saale) Germany
Uboppvxlbybdqrvpjgree Ancydoep Augsburg Germany
Kywdqksq Oqzlkv gslhawqhbrbzqu kvfgsmnsi Aaslhnz dgu oxxltowahfufi Rtoqag Aalen Germany
Uqsizxzcyl Guemwbf Hmraujrb Amfivba Athens Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
15.04.2023
Greece Greece
Recruiting
15.04.2023

Trial locations

Acalabrutinib is a medication that works by blocking a specific protein in the body that helps cancer cells grow. It is used in this trial to see if it can help stop the progression of a type of cancer called diffuse large B-cell lymphoma when used together with other cancer treatments.

Rituximab is a medication that targets and attaches to a specific protein found on the surface of certain cancer cells. By doing this, it helps the body’s immune system to destroy these cancer cells. In this trial, it is used as part of a combination treatment to help fight the cancer more effectively.

CHOP is a combination of four different chemotherapy drugs that work together to kill cancer cells. Each drug in the CHOP regimen attacks the cancer cells in a different way, making it harder for the cancer to survive and grow. In this trial, a reduced dose of CHOP, called R-miniCHOP, is used to treat older adults with a specific type of lymphoma.

Diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS) – This is a type of non-Hodgkin lymphoma characterized by large B-cells that grow rapidly. It typically starts in lymph nodes but can also affect other organs. The disease progresses quickly, with symptoms such as swollen lymph nodes, fever, and weight loss. It can spread to other parts of the body, including the bone marrow and central nervous system.

Primary cutaneous diffuse large B-cell lymphoma, leg type – This lymphoma primarily affects the skin, particularly on the legs. It presents as rapidly growing tumors or nodules on the skin. The disease progresses with the potential to spread to other areas of the skin and sometimes to internal organs. It is characterized by large B-cells in the skin tissue.

Intravascular large B-cell lymphoma – This rare lymphoma involves the growth of large B-cells within the blood vessels. It often affects the skin and central nervous system, leading to symptoms like skin lesions and neurological issues. The disease progresses as these cells obstruct blood flow, causing organ dysfunction. It can be challenging to diagnose due to its non-specific symptoms.

Epstein-Barr virus-positive diffuse large B-cell lymphoma not otherwise specified (EBV+ DLBCL NOS) – This lymphoma is associated with the Epstein-Barr virus and involves large B-cells. It typically affects older adults and can present with symptoms like swollen lymph nodes and fever. The disease progresses with the potential to involve multiple organs. It is characterized by the presence of EBV in the tumor cells.

Human herpesvirus 8-positive diffuse large B-cell lymphoma not otherwise specified (HHV8+ DLBCL NOS) – This lymphoma is linked to human herpesvirus 8 and involves large B-cells. It often occurs in individuals with compromised immune systems. The disease progresses with symptoms such as lymph node enlargement and systemic involvement. It is characterized by the presence of HHV8 in the tumor cells.

Primary mediastinal (thymic) large B-cell lymphoma – This type of lymphoma originates in the thymus, located in the mediastinum. It presents with symptoms like chest pain, cough, and breathing difficulties. The disease progresses as the tumor grows and may spread to nearby structures. It is characterized by large B-cells in the thymic tissue.

B-cell lymphoma, with intermediate features between diffuse large B-cell lymphoma and classical Hodgkin lymphoma – This lymphoma exhibits characteristics of both DLBCL and Hodgkin lymphoma. It presents with symptoms like swollen lymph nodes and fever. The disease progresses with the potential to involve multiple lymph node regions. It is characterized by a mix of cell types found in both DLBCL and Hodgkin lymphoma.

Follicular lymphoma grade 3B – This is a type of non-Hodgkin lymphoma with large B-cells arranged in follicular patterns. It presents with symptoms like painless lymph node swelling. The disease progresses with the potential to transform into a more aggressive form. It is characterized by a high number of large cells in the lymph nodes.

High-grade B-cell lymphoma not otherwise specified (NOS) – This aggressive lymphoma involves large B-cells and presents with rapidly growing lymph nodes. It can affect various organs and tissues. The disease progresses quickly, often requiring prompt medical attention. It is characterized by high-grade features in the tumor cells.

High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements – This lymphoma is marked by genetic changes involving MYC, BCL2, and/or BCL6 genes. It presents with aggressive growth and symptoms like swollen lymph nodes and fever. The disease progresses rapidly, often involving multiple organs. It is characterized by specific genetic rearrangements in the tumor cells.

T-cell/histiocyte-rich large B-cell lymphoma – This rare lymphoma involves large B-cells with a significant number of T-cells and histiocytes. It presents with symptoms like lymph node enlargement and systemic symptoms. The disease progresses with the potential to affect various organs. It is characterized by a unique cellular composition in the tumor.

Diffuse large B-cell lymphoma associated with chronic inflammation – This lymphoma occurs in areas of long-standing inflammation. It presents with symptoms like swelling and pain in the affected area. The disease progresses as the lymphoma cells grow in the inflamed tissue. It is characterized by the presence of large B-cells in chronically inflamed areas.

Anaplastic lymphoma kinase-positive large B-cell lymphoma (ALK+ large B-cell lymphoma) – This rare lymphoma involves large B-cells with ALK gene rearrangements. It presents with symptoms like swollen lymph nodes and systemic symptoms. The disease progresses with the potential to spread to other organs. It is characterized by the presence of ALK protein in the tumor cells.

Large B-cell lymphoma with IRF4 rearrangement – This lymphoma involves large B-cells with genetic changes in the IRF4 gene. It presents with symptoms like lymph node enlargement and systemic symptoms. The disease progresses with the potential to affect various organs. It is characterized by specific genetic rearrangements in the tumor cells.

Trial ID:
2022-501187-18-00
Protocol code:
ARCHED/GLA 2022-1
Trial Phase:
Therapeutic confirmatory (Phase III)

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