Thalidomide Maintenance Treatment in DLBCL

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


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).


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.

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


Yes No Not Sure

Inclusion Criteria

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

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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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