Actively Recruiting
Acalabrutinib in Combination With R-miniCHOP in Older Adults With Untreated Diffuse Large B-Cell Lymphoma
Led by Universität des Saarlandes · Updated on 2023-08-31
330
Participants Needed
17
Research Sites
286 weeks
Total Duration
On this page
Sponsors
U
Universität des Saarlandes
Lead Sponsor
U
University of Leipzig
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Acalabrutinib in Combination With R-miniCHOP in Older Adults With Untreated Diffuse Large B-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided signed informed consent and understand the study purpose and risks
- Willing and able to participate in all study evaluations and procedures, including swallowing capsules and tablets
- Men and women over 80 years old, or aged 61 to 80 and ineligible for full dose R-CHOP based on investigator assessment
- Male patients sexually active with women of childbearing potential must agree to use effective contraception and barrier methods during the study
- Female patients of childbearing potential who are sexually active must agree to use highly effective contraception during the study
- Histologically confirmed untreated CD20+ diffuse large B-cell lymphoma of various specific subtypes as defined by 2017 WHO classification
- Disease stage I with bulky mass of 7.5 cm or more, II, III, or IV according to Ann Arbor classification
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2; ECOG 3 acceptable if due to lymphoma
- Laboratory values meeting specified minimum neutrophil and platelet counts, liver enzymes, bilirubin, and kidney function unless attributable to lymphoma or Gilbert's syndrome
You will not qualify if you...
- Presence of severe or uncontrolled systemic diseases that would interfere with study participation or compliance
- Significant heart disease including recent heart attack, symptomatic arrhythmias, heart failure, or low left ventricular ejection fraction below 40%, except controlled atrial fibrillation
- Severe lung dysfunction unless caused by lymphoma
- Severe psychiatric or neurological disorders that impair participation
- Persistent severe neuropathy (grade 3 or 4)
- Inability to swallow acalabrutinib or conditions impairing drug absorption such as severe gastrointestinal diseases or prior major bowel surgery
- Previous malignancies affecting study compliance except certain treated skin cancers, carcinoma in situ, or low-risk prostate cancer as specified
- Live virus vaccination within 28 days before randomization
- Known HIV infection
- Active significant infections
- History or ongoing progressive multifocal leukoencephalopathy (PML)
- Active hepatitis B or C infection as defined by specific testing criteria
- Stroke or intracranial bleeding within 6 months before randomization
- Clinically relevant bleeding disorders
- Major surgery within 30 days before randomization without full recovery
- Pregnant or breastfeeding women
- Life-threatening illnesses or conditions compromising safety
- Central nervous system lymphoma involvement
- Use of warfarin or equivalent vitamin K antagonists; other anticoagulants allowed
- Treatment with strong CYP3A inhibitors or inducers near study start
- Prior exposure to BTK inhibitors or high-dose anthracyclines
- Prior lymphoma therapy except limited steroids, vincristine, or rituximab prephase
- Concurrent participation in another therapeutic clinical trial
- Use of proton-pump inhibitors unless switched to allowed alternatives
- Use of investigational drugs within 30 days or 5 half-lives before study drug start
AI-Screening
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Trial Site Locations
Total: 17 locations
1
Saarland University Medical Center
Homburg, Saarland, Germany, 66421
Actively Recruiting
2
MVZ am Klinikum Aschaffenburg
Aschaffenburg, Germany
Not Yet Recruiting
3
Helios Klinikum Emil von Behring
Berlin, Germany
Actively Recruiting
4
Onkologische Schwerpunktpraxis Kurfürstendamm
Berlin, Germany
Not Yet Recruiting
5
Gemeinschaftspraxis Mohm/Prange-Krex
Dresden, Germany
Not Yet Recruiting
6
Universitätsklinikum Gießen und Marburg, Standort Gießen
Giessen, Germany
Actively Recruiting
7
Universitätsmedizin Greifswald
Greifswald, Germany
Actively Recruiting
8
Universitätsmedizin Halle (Saale)
Halle, Germany
Actively Recruiting
9
Städtisches Klinikum Karlsruhe
Karlsruhe, Germany
Actively Recruiting
10
Johannes Wesling Klinikum
Minden, Germany
Not Yet Recruiting
11
Rheinland Klinikum-Lukaskrankenhaus Neuss
Neuss, Germany
Not Yet Recruiting
12
Brüderkrankenhaus St. Josef
Paderborn, Germany
Not Yet Recruiting
13
CaritasKlinikum Saarbrücken St. Theresia
Saarbrücken, Germany
Actively Recruiting
14
Klinikum Mutterhaus der Borromäerinnen
Trier, Germany
Actively Recruiting
15
Krankenhaus der Barmherzigen Brüder Trier
Trier, Germany
Not Yet Recruiting
16
Bundeswehrkrankenhaus Ulm
Ulm, Germany
Not Yet Recruiting
17
Universitätsklinikum Ulm
Ulm, Germany
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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