Actively Recruiting
Acalabrutinib with Rituximab and Reduced Dose CHOP (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
34 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
Researchers are studying the effect of adding the drug Acalabrutinib to the standard R-miniCHOP treatment in older adults with untreated diffuse large B-cell lymphoma (DLBCL). The main goal is to find out if this combination can help patients live longer without their cancer getting worse. This is a randomized, open-label phase 3 clinical trial led by Universität des Saarlandes. Participants are randomly assigned to one of two groups: one group receives the standard R-miniCHOP treatment alone, and the other group receives R-miniCHOP combined with Acalabrutinib. The R-miniCHOP regimen includes rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone given in cycles every three weeks. The group receiving Acalabrutinib takes the drug twice daily from the first cycle until the eighth cycle. During the study, participants will undergo regular assessments for up to five years to monitor progression-free survival, overall survival, remission rates, adverse events, and other health outcomes. Researchers will also track how well patients tolerate the treatments, including dose adjustments and any side effects. The total participation time includes these long-term follow-ups to evaluate the treatments' effects and safety.
CONDITIONS
Brief 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...
- Able to understand the study purpose and risks and provide signed informed consent
- Willing and able to participate in all study evaluations and swallow capsules and tablets without difficulty
- Men and women 61 years or older; those between 61 and 80 must be ineligible for full-dose R-CHOP based on investigator assessment
- Men who are sexually active with women of childbearing potential must agree to use effective contraception including barrier methods
- Women of childbearing potential who are sexually active must agree to use effective contraception
- Histologically confirmed, previously untreated CD20+ diffuse large B-cell lymphoma as defined by 2017 WHO classification
- Disease stage I with bulky mass or stages II to IV according to Ann Arbor classification
- ECOG performance status 0, 1, or 2; score of 3 allowed if directly due to lymphoma
- Meet laboratory criteria for blood counts and organ function unless abnormality is due to lymphoma
You will not qualify if you...
- Severe or uncontrolled systemic diseases or conditions that affect study participation
- Significant cardiovascular disease including recent heart attack, heart failure, or severe arrhythmias; controlled atrial fibrillation allowed
- Severe pulmonary dysfunction unless caused by lymphoma
- Severe psychiatric or neurologic disease affecting compliance
- Persistent neuropathy grade 3 or 4
- Gastrointestinal conditions preventing swallowing or absorption of study drugs
- Prior malignancies affecting compliance except certain treated skin or low risk cancers
- Live virus vaccination within 28 days before randomization
- Known HIV infection
- Active significant infections
- Progressive multifocal leukoencephalopathy (PML) history
- Active hepatitis B or C infection or positive viral tests
- Recent stroke or brain hemorrhage within 6 months
- Clinically relevant bleeding disorders
- Major surgery within 30 days before randomization
- Pregnant or breastfeeding women
- Life-threatening illness or conditions compromising safety
- Central nervous system lymphoma involvement
- Prior or concurrent transformed chronic lymphocytic leukemia
- Use of warfarin or equivalent anticoagulants; other anticoagulants allowed
- Use of strong CYP3A inhibitors or inducers near study start
- Prior BTK inhibitor exposure
- High-dose anthracycline use
- Prior lymphoma therapy except limited steroid, vincristine, or rituximab prephase
- Concurrent participation in another therapeutic clinical trial
- Use of proton-pump inhibitors unless switched to other acid reducers
- Recent investigational drug use within 30 days or five half-lives
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 18 weeks
Participants receive 6 cycles of R-miniCHOP chemotherapy with or without Acalabrutinib and 2 additional doses of Rituximab. Treatment cycles repeat every 3 weeks.
6 treatment cycles every 3 weeks plus 2 additional Rituximab doses
Duration - Up to 5 years
Participants are monitored for progression-free survival, overall survival, remission rates, adverse events, and other outcomes for up to 5 years after treatment.
Periodic visits for assessment during follow-up
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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