Thalidomide Maintenance Treatment in DLBCL

  • STATUS
    Recruiting
  • End date
    Dec 21, 2023
  • participants needed
    226
  • sponsor
    Nanfang Hospital of Southern Medical University
Updated on 21 January 2021
rituximab
b-cell lymphoma

Summary

This is a randomized, multi-center,phase III study to evaluate the ability of thalidomide maintenance therapy to prolong relapse-free survival in diffuse large B cell lymphoma(DLBCL).

Description

This is a randomized, phase III study to evaluate the ability of thalidomide maintenance therapy to prolong relapse-free survival(RFS), in diffuse large B cell lymphoma(DLBCL).Patients will be enrolled after successful standard induction therapy (CR or CRu following standard R-CHOP-like therapy with 8 infusions of rituximab plus CHOP-like chemotherapy (4-8 cycles). Patients will be followed until an event occurs as defined in the protocol. To evaluate the clinical efficacy of thalidomide maintenance therapy as compared to observation in patients with DLBCL who have achieved a complete remission after appropriate first-line therapy, measured by RFS, 226 patients with DLCBL will be recruited.

Details
Condition Diffuse Large B-Cell Lymphoma
Treatment thalidomide, Observation
Clinical Study IdentifierNCT03016000
SponsorNanfang Hospital of Southern Medical University
Last Modified on21 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

NCCN-IPI>1
Known IPI, cell of origin and DHL at time of diagnosis
Negative pregnancy test
Men must agree not to father a child during the therapy
to 8 cycles R-CHOP/like, total of 8 x Rituximab
CR, CRu

Exclusion Criteria

Transformed lymphoma
Secondary malignancy
HIV positive
Evidence of CNS involvement
Cardiac dysfunction (systolic ejection fraction <50%)
Creatinine > 2.0 mg/dl
Clear my responses

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