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

Sponsor

Nanfang Hospital of Southern Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04544059

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diffuse Large B Cell Lymphoma	Drug: Lenalidomide	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

87 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2020

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.

Arm

Intervention/Treatment

Experimental: 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.

Drug: Lenalidomide

Outcome Measures

Primary Outcome Measures

The 2-year central nervous system relapse rates [two year]
The 2-year central nervous system relapse rates

Secondary Outcome Measures

The 2-year overall survival [two year]
The 2-year overall survival
The 2-year progression-free survival [two year]
The 2-year progression-free survival
Incidence of treatment-emergent adverse events [two year]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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