NCT06151080RecruitingPhase 2
Lenalidomide Combined With G-CHOP in the Treatment of Newly Diagnosed DLBCL With FL
An Open, Single-arm Clinical Study of Lenalidomide Combined With G-CHOP(LO-CHOP) in the Treatment of Newly Diagnosed Diffuse Large B-cell Lymphoma With Follicular Lymphoma (CDLBCL-FL).
Source: ClinicalTrials.gov · Last updated 19 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To evaluate the efficacy and adverse effects of lenalidomide combined with G-CHOP(LO-CHOP) in the treatment of newly diagnosed diffuse large B-cell lymphoma with follicular lymphoma (CDLBCL-FL).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 38 (estimated)
- First submitted
- 21 Nov 2023
- Start date
- 22 Nov 2023
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- The First Affiliated Hospital of Xiamen University
- NCT number
- NCT06151080
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 38
- From 22 Nov 2023 to the primary completion date, 31 Aug 2027
- 1 site in 1 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.
Other illness
- HIV-positive patients and/or HCV-active infections (recorded through HCV-RNA-positive testing)
- Clinically evident secondary cardiovascular diseases such as uncontrollable hypertension (resting diastolic pressure\>115 mmHG), uncontrolled arrhythmias, symptomatic angina pectoris, or NYHA III-IV congestive heart failure.
- Severe chronic obstructive pulmonary disease complicated with hypoxemia.
- Active bacterial, fungal, and/or viral infections beyond the control of systemic therapy
- Except for cured skin basal cell carcinoma or cervical carcinoma in situ, or early prostate cancer that does not require systemic treatment or early breast cancer only requires surgery. Other malignant tumors have occurred within the past 3 years or at the same time
Other
- DLBCL of primary and secondary centers;
Who the study is looking for
- Age: 18-70 years old, gender is not limited;
- According to the REAL/WHO classification, the newly diagnosed diffuse large b-cell lymphoma with follicular lymphoma (CDLBCL-FL): the same lymph node specimen showed diffuse large b-cell lymphoma and follicular lymphoma, or the tissue specimen showed diffuse large b-cell lymphoma and indolent lymphoma in bone marrow pathology; or the different group specimens suggested diffuse large b-cell lymphoma and/or follicular lymphoma, respectively, with stage II-IV.
- Using the Lugano 2014 lymphoma response evaluation criteria, there must be at least one measurable or evaluable lesion: PET/CT can evaluate the lesion, CT or MRI can evaluate the lesion in the node with a diameter greater than 1.5 cm, a short diameter greater than 1.0 cm, or an extranodal lesion with a diameter greater than or equal to 1.0 cm
- ECOG 0-2
- Left ventricular ejection fraction (LVEF) was less than 45%
- HBV-positive serology (occult carriers: anti-HBeAg +, anti-HBsAg-, anti-HBsAg +/-) can only be enrolled if the HBV-dna test is negative.
- Normal major organ function: liver function: serum bilirubin ≤2.0 × ULN, serum ALT and AST ≤2.5 × ULN, renal function: serum CR ≤2.0 × ULN; (unless caused by lymphoma)
- Absolute neutrophil count (ANC)≥1.0 × 109 l, platelet count (PLT)≥100 × 109 L, hemoglobin content (HGB)≥80 g L, if myeloma was involved, ANC ≥0.75 × 109 L, platelet count (PLT)≥50 × 109 L, HGB content (HGB) was not required.
- Life expectancy ≥6 months
- Informed consent (all studies had to sign a patient's informed consent form)
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bing Xu Coordinator of this site? Confirm its status | Xiamen | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.