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Trial Title:
Lenalidomide Combined With G-CHOP in the Treatment of Newly Diagnosed DLBCL With FL
NCT ID:
NCT06151080
Condition:
DLBCL - Diffuse Large B Cell Lymphoma
Follicular Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lenalidomide
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Lenalidomide combined with G-CHOP (LO CHOP)
Description:
Lenalidomide combined with G-CHOP to treat newly diagnosed diffuse large B-cell lymphoma
with follicular lymphoma (CDLBCL-FL)
Arm group label:
LO-CHOP
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 G-CHOP(LO-CHOP) in the treatment of newly diagnosed diffuse
large B-cell lymphoma with follicular lymphoma (CDLBCL-FL).
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Bing Xu
Address:
City:
Xiamen
Zip:
361000
Country:
China
Status:
Recruiting
Contact:
Last name:
Bing Xu
Phone:
+8618750918842
Email:
xubingzhangjian@126.com
Start date:
November 22, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
The First Affiliated Hospital of Xiamen University
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Collaborator:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
Jiangxi Provincial Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Fujian Cancer Hospital
Agency class:
Other
Source:
The First Affiliated Hospital of Xiamen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06151080
