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

Xiamen University

Status and phase: Enrolling; Phase 2

Conditions: Follicular Lymphoma; DLBCL - Diffuse Large B Cell Lymphoma

Treatments: Drug: Lenalidomide combined with G-CHOP (LO CHOP)

Study type: Interventional

Funder types: Other

Identifiers

NCT06151080

XMDYYYXYK-01

Details and patient eligibility

About

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).

Full 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).

Enrollment: 38 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

LO-CHOP

Experimental group

Description:

Lenalidomide combined with G-CHOP

Treatment:

Drug: Lenalidomide combined with G-CHOP (LO CHOP)