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An open, one-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).

An open, one-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
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075896
Enrollment
Unknown
Registered
2023-09-19
Start date
2023-09-25
Completion date
Unknown
Last updated
2023-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse large b-cell lymphoma

Interventions

Group 1:Lenalidomide combined with G-CHOP (LO CHOP)

Sponsors

The First Aiffiliated hosptical of xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
Complete remission rate;

Secondary

MeasureTime frame
1-YEAR progression-free survival;Overall survival;

Countries

China

Contacts

Public ContactBing Xu

The First Aiffiliated hosptical of xiamen University

xubingzhangjian@126.com+86 187 5091 8842

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026