Lenalidomide Plus R-CHOP for CNS Relapse Prophylaxis in Diffuse Large B-cell Lymphoma

Diffuse Large B Cell Lymphoma Clinical Trial

Official title:

Lenalidomide Plus R-CHOP for CNS Relapse Prophylaxis in Diffuse Large B-cell Lymphoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04544059
• Other study ID #: NFDLBCL-CNS1
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 1, 2020
• Est. completion date: October 1, 2024

Study information

• Verified date: September 2020
• Source: Nanfang Hospital of Southern Medical University
• Contact: Ru Feng, M.D.
• Phone: 86-20-61641613
• Email: ruth1626[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label, multicenter, phase 2 trial to explore the efficacy and safety of the combination of lenalidomide and R-CHOP for preventing the CNS relapse in the high-risk diffuse large B cell lymphoma.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 87
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

age 18-72 years histologically confirmed DLBCL High risk for CNS recurrence: CNS-IPI:4-6 or involvement of testicular, kidneys or adrenal glands.

No pregnancy plans during treatment

Exclusion Criteria:

Evidence of CNS involvement, Transformed lymphoma, Primary mediastinal B-cell lymphoma EBV+DLBCL, Secondary malignancy, HIV positive, Creatinine > 2.0 mg/dl Intending to hematopoietic stem cell transplantation history of severe thrombus Pregnant or lactating women

Related Conditions & MeSH terms

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

Intervention

Drug:
• Lenalidomide
Lenalidomide orally 25 mg per day was administered on days 1 through 10 of each cycle and delivered concomitantly with standard dose R-CHOP-21 regimen (rituximab 375 mg/m2, cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2 or Liposome doxorubicin 30mg/m2, vincristine 1.4 mg/m2 [capped at 2.0 mg], all on day 1; prednisone 100 mg per day on days 1 through 5). All patients received aspirin 100mg per day prophylaxis throughout, unless they were on therapeutic dose warfarin or low molecular weight heparin for intercurrent conditions. The treatment continued for a maximum of six to eight cycles or until disease progression. Tumor lysis prophylaxis, antiemetics, and supportive care were standard of care.

Locations

Country	Name	City	State
China	Nanfang hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The 2-year central nervous system relapse rates	The 2-year central nervous system relapse rates	two year
Secondary	The 2-year overall survival	The 2-year overall survival	two year
Secondary	The 2-year progression-free survival	The 2-year progression-free survival	two year
Secondary	Incidence of treatment-emergent adverse events	Adverse events were classified as defined by the National Cancer Institute Common Toxicity Criteria, version 2. Safety evaluations were focused especially on neurological symptoms and the development of deep venous thrombosis (DVT).	two year