Combining lenalidomide with G-CHOP for treating 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).
This study is testing if adding lenalidomide to the G-CHOP treatment can help people newly diagnosed with diffuse large B-cell lymphoma and follicular lymphoma feel better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Xiamen University Academic / other |
| Locations | 1 site (Xiamen, Fujian) |
| Trial ID | NCT06151080 on ClinicalTrials.gov |
What this trial studies
This Phase 2, open-label clinical trial evaluates the effectiveness and safety of lenalidomide in combination with G-CHOP (LO-CHOP) for patients newly diagnosed with diffuse large B-cell lymphoma and follicular lymphoma. The study aims to assess key outcomes such as complete response rates, overall survival, and progression-free survival, while also monitoring adverse effects associated with the treatment. Participants will undergo treatment and be closely monitored to determine the efficacy of this combined approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with newly diagnosed diffuse large B-cell lymphoma and follicular lymphoma.
Not a fit: Patients with severe cardiac issues or those with certain viral infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with this specific type of lymphoma.
How similar studies have performed: Other studies have shown promising results with similar combinations of therapies in treating lymphomas, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Xiamen, Fujian
- Bing Xu — Xiamen, Fujian, China (Recruiting)
Study contacts
- Principal investigator: Bing Xu, PhD — The First Aiffiliated hosptical of xiamen University
- Study coordinator: Bing Xu, PhD
- Email: xubingzhangjian@126.com
- Phone: +86 187 5091 8842
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.