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

NCT ID: NCT04544059

Last Updated: 2020-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2024-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Diffuse Large B Cell Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Lenalidomide

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Ru Feng

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ru Feng

Role: PRINCIPAL_INVESTIGATOR

Department of Hematology, Nanfang Hospital, Southern Medical University

Locations

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Nanfang hospital

Guangzhou, Guangdong, China

Site Status

Countries

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China

Central Contacts

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Ru Feng, M.D.

Role: CONTACT

86-20-61641613

Xiaolei Wei, M.D.

Role: CONTACT

86-20-61641613

Other Identifiers

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NFDLBCL-CNS1

Identifier Type: -

Identifier Source: org_study_id

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