NCT06151080 Lenalidomide Combined With G-CHOP in the Treatment of Newly Diagnosed DLBCL With FL
| NCT ID | NCT06151080 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The First Affiliated Hospital of Xiamen University |
| Condition | DLBCL - Diffuse Large B Cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 38 participants |
| Start Date | 2023-11-22 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 38 participants in total. It began in 2023-11-22 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: 1. Age: 18-70 years old, gender is not limited; 2. 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. 3. 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 4. ECOG 0-2 5. Left ventricular ejection fraction (LVEF) was less than 45% 6. HBV-positive serology (occult carriers: anti-HBeAg +, anti-HBsAg-, anti-HBsAg +/-) can only be enrolled if the HBV-dna test is negative. 7. 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) 8. 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. 9. Life expectancy ≥6 months 10. Informed consent (all studies had to sign a patient's informed consent form) Exclusion Criteria: 1. DLBCL of primary and secondary centers; 2. HIV-positive patients and/or HCV-active infections (recorded through HCV-RNA-positive testing) 3. 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. 4. Severe chronic obstructive pulmonary disease complicated with hypoxemia. 5. Active bacterial, fungal, and/or viral infections beyond the control of systemic therapy 6. 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
Contact & Investigator
Bing Xu, PhD
PRINCIPAL INVESTIGATOR
The First Aiffiliated hosptical of xiamen University
Frequently Asked Questions
Who can join the NCT06151080 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying DLBCL - Diffuse Large B Cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06151080 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06151080 currently recruiting?
Yes, NCT06151080 is actively recruiting participants. Contact the research team at xubingzhangjian@126.com for enrollment information.
Where is the NCT06151080 trial being conducted?
This trial is being conducted at Xiamen, China.
Who is sponsoring the NCT06151080 clinical trial?
NCT06151080 is sponsored by The First Affiliated Hospital of Xiamen University. The principal investigator is Bing Xu, PhD at The First Aiffiliated hosptical of xiamen University. The trial plans to enroll 38 participants.