Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2025-12-24 @ 9:38 PM
NCT ID:
NCT06220032
Eligibility Criteria:
Inclusion Criteria:
1. Untreated patients with a confirmed histologic diagnosis of CD20+ DLBCL according to WHO classification 2022:
* DLBCL, not otherwise specified (NOS)
* High-grade B-cell lymphoma NOS
* High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 translocation when DA-EPOCH-R is not an option. R2- CHOP is allowed.
* Follicular lymphoma
* T-cell/histiocyte-rich B cell lymphoma (THRBCL)
Note: Transformed, previously untreated lymphoma is allowed.
Note: 5-day treatment of dexamethasone 15 mg/day or prednisone 100 mg/day or local radiotherapy in order to control life-threatening/invalidating tumor related symptoms is allowed.
Note: It is allowed to start with a first cycle of R-CHOP21 pending the FISH results.
2. Planned treatment with 6 R-CHOP21. The following regimens are also allowed:
* Treatment with reversed R-CHOP21
* Treatment with R2-CHOP21 (6 R-CHOP21 + lenalidomide 15 mg day 1-14) in case of double hit lymphoma
* Two additional administrations of rituximab after 6 cycles of R-CHOP21
* High dosis MTX and/or MTX-it for CNS prophylaxis
3. Ann Abor stages II-IV and stage I if the treatment plan is 6 R-CHOP21 in case of bulky disease (defined as a ≥10 cm mass);
4. Age ≥ 18 years;
5. WHO performance status ≤ 2, WHO 3 performance status is allowed when considered directly related to the DLBCL;
6. Negative pregnancy test at study entry for women of childbearing potential;
7. Female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agrees to practice two effective methods of contraception, at the same time, from the time of signing the informed consent through at least 12 months after the last dose of protocol treatment, or agrees to completely abstain from heterosexual intercourse;
8. Male patient, even if surgically sterilized, (i.e., status post vasectomy) agrees to practice effective barrier contraception during the entire study period and through 12 months after the last dose of protocol treatment, or agrees to completely abstain from heterosexual intercourse;
9. Patient is able to adhere to the study visit schedule and other protocol requirements;
10. Written informed consent.
Exclusion Criteria:
1. Any of the following B-cell lymphomas according to WHO classification 2022:
o Central Nervous System involvement by DLBCL;
Note: high CNS-IPI is allowed
* Testicular DLBCL;
* Primary mediastinal B-cell lymphoma;
* Epstein-Barr virus (EBV) post-transplant lymphoproliferative disorder;
2. Any prior malignancy or present malignancy other than DLBCL that required or requires systemic therapy. Prior surgery or local radiotherapy is allowed in case the heart has not been exposed.
3. Patients requiring treatment with mini-R-CHOP
4. Pre-existing cardiac disease including:
* LVEF \<50% measured with echocardiography (2D or 3D)
* Symptomatic heart failure (NYHA ≥II) or hospitalization for heart failure in the last year;
* Refractory anginal symptoms
* Cardiac arrhythmias not controlled with optimal medical treatment, in case of atrial fibrillation the ventricular response needs to be \<110/min;
* Significant valvular dysfunction on echocardiography;
* Non-ischemic cardiomyopathy
5. Non-diagnostic/poor transthoracic echocardiography imaging quality at baseline;
6. Severe pulmonary dysfunction defined as breathlessness at rest (COPD GOLD III or IV), unless clearly related to DLBCL;
7. Severe neurological or psychiatric disease;
8. Inadequate hematological function (absolute Neutrophil Count (ANC) \<1.0x109/L or platelets \<75x109/L), unless clearly related to DLBCL;
9. Significant hepatic dysfunction (serum bilirubin or transaminases ≥ 3 times the upper limit of normal) unless related to lymphoma infiltration of the liver;
10. Active hepatitis B or C infection (serology testing is required at screening). Patients positive for hepatitis B surface antigen (HBsAg) regardless of antibody status or HBsAg negative but anti-HBc positive are only eligible if HBV-PCR is negative and patients are protected with lamuvidine or entecavir. Patients with positive hepatitis C serology are only eligible if HCV-(RNA) is confirmed negative;
11. Significant renal dysfunction (creatinine clearance \< 30 ml/min after rehydration) or requiring dialysis;
12. Active uncontrolled fungal, bacterial and/or viral infection;
13. Patient known to be HIV-positive;
14. Breast-feeding female patients;
15. Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
16. Participation in another clinical trial with anti-cancer therapy or a cardiovascular drug.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06220032
Study Brief:
Protocol Section:
NCT06220032