NCT06516978Not yet recruitingPhase 2
A Study Comparing the Efficacy and Safety of Pola-RCHP-X Versus RCHOP-X and Pola-RCHP in Previously Untreated Patients With DLBCL
A Prospective, Open-Label, Multicenter, Randomized Controlled Study Comparing the Efficacy and Safety of Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Combined With Orelabrutinib/Chidamide/Venetoclax/Lenalidomide/PD1 (Pola-RCHP-X) Versus RCHOP-X and Pola-RCHP in Previously Untreated Patients With Diffuse Large B-Cell Lymphoma
Source: ClinicalTrials.gov · Last updated 24 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study aims to compare the efficacy and safety of Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone combined with Orelabrutinib/Chidamide/Venetoclax/Lenalidomide/PD1 (Pola-RCHP-X) versus RCHOP-X and Pola-RCHP in previously untreated patients with DLBCL.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 528 (estimated)
- First submitted
- 18 Jul 2024
- Start date
- 1 Oct 2024
- Primary completion date
- 1 Oct 2028
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT06516978
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 528
- From 1 Oct 2024 to the primary completion date, 1 Oct 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Significant or extensive history of cardiovascular disease such as New York Heart Association Class III or IV cardiac disease or Objective Assessment Class C or D, myocardial infarction within the last 6 months prior to the start of Cycle 1, unstable arrhythmias, or unstable angina
- Any active infection within 7 days prior to Cycle 1 Day 1 that would impact participant safety
Other illness
- History of other malignancy that could affect compliance with the protocol or interpretation of results
- Suspected active or latent tuberculosis (as confirmed by a positive interferon-gamma release assay)
- Participants with a history of progressive multifocal leukoencephalopathy
Lab values
- Any of the following abnormal laboratory values (unless any of these abnormalities are due to underlying lymphoma):
- Serum AST and ALT ≥ 2.5 x ULN Total bilirubin ≥ 1.5 x ULN Serum creatinine clearance \< 40 mL/min (using Cockcroft-Gault formula)
Other
- Contraindication to any of the individual components of Pola-RCHP or Orelabrutinib/Chidamide/Venetoclax/Lenalidomide/PD1
- History or presence of an abnormal ECG that is clinically significant in the investigator's opinion
Who the study is looking for
- Sign the informed consent form
- Previously untreated participants with CD20-positive DLBCL
- Life expectancy ≥ 6 months
- IPI score 2-5
- ECOG Performance Status of 0, 1, or 2
- Left ventricular ejection fraction (LVEF) ≥ 50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)
- Adequate hematologic function (unless due to underlying disease, as established for example, by extensive bone marrow involvement or due to hypersplenism secondary to involvement of the spleen by DLBCL per the investigator for which blood product transfusions are permitted) defined as follows:
- Hemoglobin ≥ 9.0 g/dL without packed RBC transfusion during 7 days before first treatment ANC ≥ 1.0 x 10\^9/L PLT ≥ 75 x 10\^9/L
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.