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 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT05498220
Eligibility Criteria:
In order to participate in this study, a subject must meet all of the eligibility criteria outlined below.
Inclusion Criteria:
1. Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
2. Biopsy proven diffuse large B-cell lymphoma (DLBCL) in the first relapse (biopsy can be from initial diagnosis). The study will allow high-grade B cell lymphoma, but not including Burkitt's lymphoma.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
4. Radiologic evidence of active disease within 28 days of starting trial therapy.
5. Only one prior line of therapy.
6. Prior cancer treatment must be completed at least 14 days prior to the start of treatment and the subject must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to ≤ Grade 1 or start of treatment.
7. Subjects may be eligible or ineligible for autologous stem cell transplant
Exclusion Criteria:
1. Known severe, active bacterial, viral, fungal, mycobacterial, parasitic, or other infections at study enrollment that may put the subject at undue risk as determined by the investigator.
2. Subjective hearing loss interfering with daily activities or evidence of greater than mild hearing loss compared to age appropriate normal on screening audiometry are excluded.
3. Women who are pregnant or breastfeeding or who intend to become pregnant within a year of the last dose of study treatment.
4. Subjects with a history of prior or concurrent second primary malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the study drugs are eligible for enrollment in the trial.
5. Previous exposure to polatuzumab vedotin.
6. History of severe allergic or anaphylactic reaction to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine.
7. Contraindication to gemcitabine or cisplatin, or dexamethasone or similar corticosteroid.
8. Symptomatic cardiac disease including ventricular dysfunction, left ventricular ejection fraction \< 40%, symptomatic coronary artery disease or symptomatic arrhythmias.
9. Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation \> 91% on room air.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05498220
Study Brief:
Protocol Section:
NCT05498220