Overview

Lenalidomide Combined With G-CHOP in the Treatment of Newly Diagnosed DLBCL With FL

Status:
Recruiting
Trial end date:
2026-12-31
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The First Affiliated Hospital of Xiamen University
Collaborators:
Fujian Cancer Hospital
Jiangxi Provincial Cancer Hospital
Sun Yat-sen University
The First Affiliated Hospital with Nanjing Medical University
Treatments:
Lenalidomide
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