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New treatment option for Large B-cell Lymphoma
Official title Acalabrutinib in Combination With R-miniCHOP in Older Adults With Untreated Diffuse Large B-Cell Lymphoma
ClinicalTrials.gov ID: NCT05820841
What this study is testing
What is R-miniCHOP + Acalabrutinib?
R-miniCHOP + Acalabrutinib is an investigational medicine, given as an once-daily, being studied as a potential treatment for large b-cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 61 and older
You may be able to join if
- 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
You likely can't join if
- Medical conditions
- Evidence of disease (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension and renal transplant) that, in the...
- Significant cardiovascular disease such as symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of...
- 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...
- Persistent neuropathy CTCAE grade 3 or 4.
See the full eligibility criteria
Who can 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. 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...
- 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...
- 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...
- 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...
What rules you out
- 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...
- 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...
- 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.
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- Received any investigational drug within 30 days or 5 half-lives (whichever is shorter) before first dose of study drug.
The study team makes the final eligibility decision.
Where it's taking place
- Homburg, Saarland, Germany
- Aschaffenburg, Germany
- Berlin, Germany
- Dresden, Germany
- Giessen, Germany
- Greifswald, Germany
- Halle, Germany
- Karlsruhe, Germany
- Minden, Germany
- Neuss, Germany
- Paderborn, Germany
- Saarbrücken, Germany
- Trier, Germany
- Ulm, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 61 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Homburg, Saarland, Germany; Aschaffenburg, Germany; Berlin, Germany; Dresden, Germany; Giessen, Germany; Greifswald, Germany and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.