The First Affiliated Hospital of Xiamen University
Phase
Phase 2
Started
2023-11-22
Last updated
2025-02-19
Condition(s) studied
DLBCL - Diffuse Large B Cell LymphomaFollicular Lymphoma
Investigational drug(s) / intervention(s)
Lenalidomide combined with G-CHOP (LO CHOP)
Lenalidomide combined with G-CHOP (LO CHOP): Lenalidomide combined with G-CHOP to treat newly diagnosed diffuse large B-cell lymphoma with follicular lymphoma (CDLBCL-FL)
Study 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
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Complete remission rate — Up to 28 months Complete remission rate was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Trial sites (1)
Facility
City
Region
Status
Bing Xu
Xiamen
Fujian
Recruiting
More The First Affiliated Hospital of Xiamen University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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