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Large B-cell LymphomaPhase 3ARCHEDNCT05820841

Acalabrutinib in Combination With R-miniCHOP in Older Adults With Untreated Diffuse Large B-Cell Lymphoma

A Phase 3 study testing R-miniCHOP + Acalabrutinib and R-miniCHOP in people with Large B-cell Lymphoma and Diffuse Large B Cell Lymphoma, run by Universität des Saarlandes at 17 sites in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to study the addition of Acalabrutinib to standard R-miniCHOP in older adults with DLBCL. The main question it aims to answer is whether progression free survival kann be prolonged with the addition of Acalabrutinib. Read more about this study

Who is it for?
Ages 61 years and older
What is being tested?
R-miniCHOP + Acalabrutinib and R-miniCHOP
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
330 participants
Where
17 sitesGermany
Study dates
7 Jun 2023to Feb 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 61 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed consent
  • Ability to understand the purpose and risks of the study and capable of giving signed informed consent which includes:
  • Compliance with the requirements and restrictions listed in the informed consent form (ICF).
  • Authorization to use protected health information/data [in accordance with the General Data Protection Regulation (GDPR)].
  • Provision of signed and dated, written ICF prior to any mandatory study specific procedures, sampling, and analyses
  • Willing and able to participate in all required evaluations and procedures in this study protocol, including swallowing capsules and tablets without difficulty.
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  • Age/Sex
  • Men and women >80 years of age or >60 up to 80 years of age and ineligible for full dose R-CHOP according to investigator assessment*.
  • We recommend classifying patients aged 61-80 as full-dose R-CHOP ineligible if they fulfill one of the following criteria: ADL <5, IADL <6, CIRS-G ≥1 score = 3, or > 8 score = 2.
  • Male patients who are sexually active with women of childbearing potential (definitions see section 17.8) must agree to use highly effective forms of contraception with the addition of a barrier method (condom) during the study (see section 17.8.1) as well as to the restrictions mentioned in section 9.13.
  • Female patients of childbearing potential (definitions see 17.8) who are sexually active must agree to use highly effective forms of contraception while on the study as well as to the restrictions mentioned in section 9.13.
  • Disease characteristics
  • Histologically proven, previously untreated CD20+ diffuse large B-cell lymphoma (DLBCL) according to the 2017 WHO classification including:
  • diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS)
  • primary cutaneous DLBCL leg type
  • intravascular large B-cell lymphoma
  • EBV+ DLBCL, NOS
  • HHV8+DLBCL, NOS
  • primary mediastinal (thymic) large B-cell lymphoma
  • B-cell lymphoma, with intermediate features between DLBCL and classical Hodgkin lymphoma
  • follicular lymphoma grade 3B
  • high-grade B-cell lymphoma, NOS
  • high-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements
  • T-cell/histiocyte-rich large B-cell lymphoma
  • DLBCL associated with chronic inflammation
  • ALK+ large B-cell lymphoma
  • large B-cell lymphoma with IRF4 rearrangement Please note: patients in whom indolent lymphoma is diagnosed concurrently with the one of the above listed diagnoses can also be included.
  • Disease Stage I with bulk ≥7.5cm, II, III or IV according to Ann Arbor Classification Type of patient and clinical characteristics
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. An ECOG Score of 3 is acceptable only if this is directly attributable to lymphoma.
  • Meet the following laboratory parameters:
  • Absolute neutrophil count (ANC) ≥ 1500 cells/µl or platelet count ≥ 100.000/µl unless directly attributable to lymphoma.
  • Serum AST and ALT ≤3 x upper limit of normal (ULN) unless directly attributable to lymphoma.
  • Total bilirubin ≤1.5 x ULN, unless directly attributable to Gilbert's syndrome or lymphoma.
  • Estimated creatinine clearance of ≥30 mL/min, calculated by Cockcroft-Gault (using actual body weight) (if male, [140-Age] x Mass [kg] / [72 x creatinine mg/dL]; multiply by 0.85 if female), or serum creatinine ≤2.5 x ULN.

Who cannot join

  • Medical conditions
  • Evidence of disease (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension and renal transplant) that, in the investigator's opinion, make it undesirable for the patient to participate in the study or that would jeopardize compliance with the protocol [e.g. a single score of 4 on one single category on the CIRS-G-Score (but not a cumulative score of 4)].
  • Significant cardiovascular disease such as symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of randomization or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or LVEF < 40%. Patients with controlled, asymptomatic atrial fibrillation are allowed to enroll on study.
  • Severe pulmonary dysfunction (CTCAE grade 3 or 4) unless associated with lymphoma.
  • Severe psychiatric or neurologic disease that, in the investigator's opinion, make it undesirable for the patient to participate in the study or that would jeopardize compliance with the protocol.
  • Persistent neuropathy CTCAE grade 3 or 4.
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  • Refractory nausea and vomiting, inability to swallow acalabrutinib, or malabsorption syndrome; chronic severe gastrointestinal disease, gastric restrictions, or bariatric surgery such as gastric bypass; partial or complete bowel obstruction, or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of study treatment.
  • History of prior malignancy that could affect compliance with the protocol or interpretation of results, except for the following:
  • Curatively treated localised basal cell carcinoma or localised squamous cell carcinoma of the skin or carcinoma in situ of the cervix or carcinoma in situ / low risk carcinoma of the prostate requiring only observation, as well as untreated low grade lymphoma except chronic lymphocytic leukemia.
  • Other cancers not specified above that have been curatively treated by surgery and/or radiation therapy from which patient is disease-free for ≥2 years (≥5 years for those treated with chemotherapy) without further treatment or which are not expected to limit survival to < 2 years.
  • Received a live virus vaccination within 28 days of randomization.
  • Known history of infection with HIV.
  • Any active significant infection (e.g., bacterial, viral or fungal) as assessed by the investigator.
  • History of or ongoing confirmed progressive multifocal leukoencephalopathy (PML).
  • Serologic status reflecting active hepatitis B or C infection.
  • Patients who are hepatitis B core antibody (anti-HBc) positive and who are hepatitis B surface antigen (HBsAg) negative will need to have a negative PCR result before randomization and must be willing to undergo DNA PCR testing during the study. Those who are HBsAg-positive or hepatitis B PCR positive will be excluded.
  • Patients who are hepatitis C antibody positive will need to have a negative PCR result before randomization. Those who are hepatitis C PCR positive will be excluded.
  • History of stroke or intracranial hemorrhage within 6 months before randomization.
  • History of clinically relevant bleeding diathesis (e.g., hemophilia, von Willebrand disease).
  • Major surgical procedure within 30 days before randomization. Note: If a patient had major surgery, they must have recovered adequately from any toxicity and/or complications from the intervention before the first dose of study drug.
  • Breastfeeding or pregnant women.
  • Current life-threatening illness, medical condition, organ system dysfunction, social, geographical or economic condition which, in the Investigator's opinion, could compromise the patient's safety or put the study at risk.
  • Diagnosis of primary central nervous system lymphoma or secondary central nervous system or meningeal involvement by lymphoma
  • Diagnosis of Richter's Transformation/transformed CLL Prior/Concomitant therapy
  • Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists. Patients using therapeutic low molecule weight heparin, direct oral anticoagulants or low dose aspirin will be eligible. Switching from vitamin K antagonists to one of the allowed anticoagulants above prior to trial entry is permitted.
  • Requires treatment with a strong cytochrome P450 3A (CYP3A) inhibitor or inducer. The use of strong CYP3A inhibitors within 1 week or strong CYP3A inducers within 3 weeks of the first dose of study drug is prohibited. See details in section 9.12.1.
  • Prior exposure to a BTK inhibitor.
  • Prior anthracycline use ≥300 mg/m2.
  • Already initiated lymphoma therapy except for steroid (max. total dose of 1000mg), vincristine (max. 1 mg once) or rituximab (max. 375mg/m2) prephase.
  • Concurrent participation in another therapeutic clinical trial.
  • Requires treatment with proton-pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Patients receiving proton pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrolment into this study.
  • Received any investigational drug within 30 days or 5 half-lives (whichever is shorter) before first dose of study drug.

Trial locations and contacts

17 sites in 1 country. Contact the study team or a site near you to ask about taking part.

17 sites in 1 country

Germany17 sites, 17 recruiting

  • MVZ am Klinikum Aschaffenburg

    Aschaffenburg

    Manfred Welslau, MD, +4960214527391, nicole.semmler-lins@mvz-klinikum-ab.de

    Not yet recruiting

  • Helios Klinikum Emil von Behring

    Berlin

    Börge Arndt, MD, +4930810262506, isabel.fuhrmann@helios-gesundheit.de

    Recruiting

  • Onkologische Schwerpunktpraxis Kurfürstendamm

    Berlin

    Kristina LErch, MD, +49308877425741, studien@onkologie-kurfuerstendamm.de

    Not yet recruiting

  • Gemeinschaftspraxis Mohm/Prange-Krex

    Dresden

    Thomas Illmer, MD, +493514400022, s.richter@gokos-dresden.de

    Not yet recruiting

  • Universitätsklinikum Gießen und Marburg, Standort Gießen

    Giessen

    Mathias Rummel, Prof MD, +4964198542603, juergen.barth@innere.med.uni-giessen.de

    Recruiting

  • Universitätsmedizin Greifswald

    Greifswald

    Christian Andreas Schmidt, Prof. MD, +4938348622006, onkologie@med.uni-greifswald.de

    Recruiting

  • Universitätsmedizin Halle (Saale)

    Halle

    Franziska Brunner, MD, +493455571386, innere4.studienzentrale@uk-halle.de

    Recruiting

  • Saarland University Medical Center

    Homburg, Saarland, 66421

    Konstantinos Christofyllakis, MD MSc, +4968411615358, konstantinos.christofyllakis@uks.eu

    Recruiting

  • Städtisches Klinikum Karlsruhe

    Karlsruhe

    Martin Bentz, Prof. MD, +49721 974-3001, Onkologie@klinikum-karlsruhe.de

    Recruiting

  • Johannes Wesling Klinikum

    Minden

    Kai Wille, MD, +496519472571, haematologie-minden@muehlenkreiskliniken.de

    Not yet recruiting

  • Rheinland Klinikum-Lukaskrankenhaus Neuss

    Neuss

    Ulf Reinhart, MD, +49 2131888 2701, Silvia.Jacquemin-Fink@rheinlandklinikum.de

    Not yet recruiting

  • Brüderkrankenhaus St. Josef

    Paderborn

    Tobias Gaska, MD, +495251 7021425, m.gauding@bk-paderborn.de

    Not yet recruiting

  • CaritasKlinikum Saarbrücken St. Theresia

    Saarbrücken

    Julian Topaly, MD, PD, +49814061345, u.schilling@caritasklinikum.de

    Recruiting

  • Klinikum Mutterhaus der Borromäerinnen

    Trier

    Rolf Mahlberg, MD, +496519472795, studienzentrale@mutterhaus.de

    Recruiting

  • Krankenhaus der Barmherzigen Brüder Trier

    Trier

    Heinz Kirchen, MD, +496512081921, i.kohl@bbtgruppe.de

    Not yet recruiting

  • Bundeswehrkrankenhaus Ulm

    Ulm

    Hanno Witte, MD, +49 731 1710-2901, BwKrhsUlmInnere@bundeswehr.org

    Not yet recruiting

  • Universitätsklinikum Ulm

    Ulm

    Andreas Viardot, Prof. MD, +4973150045901, Cto.Coordination@uniklinik-ulm.de

    Recruiting

Other trials in Germany

About this study

Official title: A Randomized, Open-label, Phase 3 Study of Acalabrutinib in Combination With Rituximab and Reduced Dose CHOP (R-miniCHOP) in OldEr Adults With Untreated Diffuse Large B-Cell Lymphoma

The goal of this clinical trial is to study the addition of Acalabrutinib to standard R-miniCHOP in older adults with DLBCL. The main question it aims to answer is whether progression free survival kann be prolonged with the addition of Acalabrutinib.

Participants will be randomised to receive either R-miniCHOP alone or R-miniCHOP with Acalabrutinib.

Being tested
R-miniCHOP + Acalabrutinib, R-miniCHOP
Keywords
Diffuse large B cell lymphoma, Older adults, Geriatric, Large B cell lymphoma, Aggressive B cell lymphoma, Acalabrutinib, R-miniCHOP, R-mini-CHOP, BTK inhibitor
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • R-miniCHOP + AcalabrutinibDrug

    • Rituximab i.v.: 375 mg/m2 (D0)
    • Cyclophosphamide i.v.: 400 mg/m² (D1)
    • Doxorubicin i.v.: 25 mg/m² (D1)
    • Vincristine i.v.: 1 mg (D1)
    • Prednisolone p.o.: 40 mg/m² (D1 to D5)
    • Acalabrutinib 100 mg p.o. twice daily starting from D1 of first R-miniCHOP cycle continuously to D21 of cycle 8.

    Cycles repeated every 3 weeks

  • R-miniCHOPDrug

    • Rituximab i.v.: 375 mg/m2 (D0)
    • Cyclophosphamide i.v.: 400 mg/m² (D1)
    • Doxorubicin i.v.: 25 mg/m² (D1)
    • Vincristine i.v.: 1 mg (D1)
    • Prednisolone p.o.: 40 mg/m² (D1 to D5).

    Cycles repeated every 3 weeks

Study groups in NCT05820841
Study groupRoleWhat they receive
Standard armActive comparator6x R-miniCHOP + 2x Rituximab.
Receives: Drug: R-miniCHOP
Experimental armExperimental6x R-miniCHOP + 2x Rituximab + Acalabrutinib.
Receives: Drug: R-miniCHOP + Acalabrutinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS) investigator assessed

    PFS, defined by the time between the day of randomization until one of the following events occurs, whichever comes first: Disease progression (PD), relapse after complete remission (CR) or death due to any cause, as per Lugano Classification of 2014. Patients who have not experienced an event at the time of analysis will be censored at the most recent date of disease assessment.

    Measured: Up to 5 years

Secondary outcomes (16)

  1. Overall survival (OS)

    OS, defined by the time between the day of randomization until death due to any cause. Patients who have not experienced an event at the time of analysis will be censored at the date when the patient was last known to be alive.

    Measured: Up to 5 years

  2. PFS based on blinded independent central review (BICR)

    Measured: Up to 5 years

  3. Event-free survival (EFS)

    EFS, defined by the time between the day of randomization until one of the following events occurs, whichever comes first: Progressive disease (PD), relapse after complete remission (CR), initiation of subsequent systemic anti-lymphoma treatment and/or irradiation or death due to any cause, as per Lugano Classification of 2014.

    Measured: Up to 5 years

  4. PFS according to Cell of Origin as per immunohistochemistry

    Measured: Up to 5 years

  5. OS according to Cell of Origin as per immunohistochemistry

    Measured: Up to 5 years

  6. EFS according to Cell of Origin as per immunohistochemistry

    Measured: Up to 5 years

  7. PFS according to molecular genotype

    Measured: Up to 5 years

  8. OS according to molecular genotype

    Measured: Up to 5 years

  9. EFS according to molecular genotype

    Measured: Up to 5 years

  10. Complete (CR) partial (PR) and overall (ORR) remission rates

    Measured: Up to 5 years

  11. Duration of Response (DoR)

    Measured: Up to 5 years

  12. Progression rate, relapse rate and central nervous system (CNS) relapse rate

    Measured: Up to 5 years

  13. Adverse events (AEs), Serious AEs, AEs of special interest, events of clinical interest, AEs leading to study treatment discontinuation or dose modification.

    Measured: Up to 5 years

  14. Rate of secondary malignancies

    Measured: Up to 5 years

  15. Treatment-related death rate

    Measured: Up to 5 years

  16. Dose intensity of miniCHOP, rituximab and acalabrutinib.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2023
  2. Study start7 Jun 2023
  3. Primary completionFeb 2029 (estimated)
  4. Study completionFeb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
330 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05820841
Sponsor's protocol ID
ARCHED / GLA 2022-1
Other IDs
U1111-1284-7084, 2022-501187-18-00
Acronym
ARCHED
Status last verified
Jun 2026
First submitted
8 Mar 2023
Last updated
29 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing R-miniCHOP + Acalabrutinib and R-miniCHOP in people with Large B-cell Lymphoma and Diffuse Large B Cell Lymphoma, run by Universität des Saarlandes at 17 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 34 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) investigator assessed (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05820841.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.

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