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:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2025-12-25 @ 4:51 AM
NCT ID:
NCT03123718
Eligibility Criteria:
Inclusion Criteria:
* Aged ≥18 years \<80
* Newly diagnosed, histologically confirmed DLBCL
* High-risk of CNS recurrence at diagnosis:
1. Age-adjusted IPI (aaIPI) ≥2 or IPI ≥4 with extranodal involvement of \>1 site plus serum lactate dehydrogenase (LDH) \> normal OR
2. Involvement of high-risk locations: bone marrow, nasal or paranasal sinuses, testis, epidural disease (paravertebral or vertebra), breast, adrenal or kidney
* Estimated life expectancy of more than 90 days
* Performance status (ECOG) ≤ 2
* Written informed consent
Exclusion Criteria:
* Psychiatric or mental disorder which make the patient unable to give an informed consent and/or adhere to the protocol
* DLBCL or following subtypes:
1. Primary mediastinal large B-cell lymphoma
2. Grey zone lymphoma)
3. Primary cutaneous DLBCL
* Previous immunochemotherapeutic treatment for DLBCL other than short-term use of corticosteroids (≤ 8 days before randomization)
* Previous radiotherapy
* CNS involvement of DLBCL at diagnosis
* HIV positive
* Any contraindication for application of RCHOP or high dose methotrexate
* Any of following laboratory results
1. Absolute neutrophil count \< 1,500 cells/mm3 (1.5 x 109/L),
2. Platelet count \< 100,000/mm3 (100 x 109/L), or \< 75,000 /mm3 in patients with bone marrow involvement,
3. Serum aspartate transaminase or serum alanine transaminase ≥3.0 x upper limit of normal (ULN),
4. Serum total bilirubin \> 2 x ULN (with the exception of hemolytic anemia),
* Serum creatinine \>2.0 x ULN or creatinine clearance \<50 mL/min
* Active cancer except curable basal cell carcinoma, cervical cancer in situ, and/or papillary thyroid cancer during the last five years
* Ejection fraction \< 45% on echocardiography
* Uncontrolled active hepatitis
* Pregnancy or breast-feeding
* Men and women of reproductive potential no agreeing to use an acceptable method of birth control during treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03123718
Study Brief:
Protocol Section:
NCT03123718