Status:
RECRUITING
Lenalidomide Combined With G-CHOP in the Treatment of Newly Diagnosed DLBCL With FL
Lead Sponsor:
The First Affiliated Hospital of Xiamen University
Collaborating Sponsors:
The First Affiliated Hospital with Nanjing Medical University
Sun Yat-sen University
Conditions:
DLBCL - Diffuse Large B Cell Lymphoma
Follicular Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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).
Detailed Description
This is a Phase 2, open-label clinical trial study that aims to evaluate the efficacy (Complete response, Overall Survival, Progression Free Survival) and adverse effects of lenalidomide combined with...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- DLBCL of primary and secondary centers;
- 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
Key Trial Info
Start Date :
November 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT06151080
Start Date
November 22 2023
End Date
December 31 2027
Last Update
February 19 2025
Active Locations (1)
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1
Bing Xu
Xiamen, Fujian, China, 361000