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).

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
China
Bing Xu
RECRUITING
Xiamen
Contact Information
Primary
Bing Xu, PhD
xubingzhangjian@126.com
+86 187 5091 8842
Backup
Zhifeng Li
lzf_xm@163.com
+86 136 0690 1162
Time Frame
Start Date: 2023-11-22
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 38
Treatments
Experimental: LO-CHOP
Lenalidomide combined with G-CHOP
Sponsors
Collaborators: Jiangxi Provincial Cancer Hospital, Sun Yat-sen University, The First Affiliated Hospital with Nanjing Medical University, Fujian Cancer Hospital
Leads: The First Affiliated Hospital of Xiamen University

This content was sourced from clinicaltrials.gov