Lenalidomide Combined With G-CHOP in the Treatment of Newly Diagnosed DLBCL With FL
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).
1 other identifier
interventional
38
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2023
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2023
CompletedStudy Start
First participant enrolled
November 22, 2023
CompletedFirst Posted
Study publicly available on registry
November 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
February 19, 2025
February 1, 2025
3.8 years
November 21, 2023
February 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Complete remission rate
Complete remission rate was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Up to 28 months
Secondary Outcomes (2)
Progression-free survival
From the randomization until the first documentation of PD or death whichever occurs first or up to 28 months
Overall survival
Up to 28 months
Study Arms (1)
LO-CHOP
EXPERIMENTALLenalidomide combined with G-CHOP
Interventions
Lenalidomide combined with G-CHOP to treat newly diagnosed diffuse large B-cell lymphoma with follicular lymphoma (CDLBCL-FL)
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The First Affiliated Hospital of Xiamen Universitylead
- The First Affiliated Hospital with Nanjing Medical Universitycollaborator
- Sun Yat-sen Universitycollaborator
- Jiangxi Provincial Cancer Hospitalcollaborator
- Fujian Cancer Hospitalcollaborator
Study Sites (1)
Bing Xu
Xiamen, Fujian, 361000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bing Xu, PhD
The First Aiffiliated hosptical of xiamen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 21, 2023
First Posted
November 30, 2023
Study Start
November 22, 2023
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
February 19, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share