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

Follicular Lymphoma Clinical Trial

Official title:

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).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06151080
• Other study ID #: XMDYYYXYK-01
• Status: Recruiting
• Phase: Phase 2
• Start date: November 22, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: December 2023
• Source: The First Affiliated Hospital of Xiamen University
• Contact: Bing Xu, PhD
• Phone: +86 187 5091 8842
• Email: xubingzhangjian[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: December 31, 2026
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Follicular Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Follicular
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• Lenalidomide combined with G-CHOP (LO CHOP)
Lenalidomide combined with G-CHOP to treat newly diagnosed diffuse large B-cell lymphoma with follicular lymphoma (CDLBCL-FL)

Locations

Country	Name	City	State
China	Bing Xu	Xiamen	Fujian

Sponsors (5)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Xiamen University	Fujian Cancer Hospital, Jiangxi Provincial Cancer Hospital, Sun Yat-sen University, The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete remission rate	Complete remission rate was determined on the basis of investigator assessments according to 2014 Lugano criteria.	Up to 28 months
Secondary	Progression-free survival	PFS was defined as the time from the date of treatment initiation to the date of first documentation of definitive disease progression (PD) or date of death from any cause, whichever occurs first.	From the randomization until the first documentation of PD or death whichever occurs first or up to 28 months
Secondary	Overall survival	OS will be measured from the date of registration to the date of the event (i.e., death) or the date of last follow-up to evaluate that event. Patients who are event-free at their last follow-up evaluation will be censored at that time point.	Up to 28 months