Thalidomide Maintenance Treatment in DLBCL

July 26, 2017 updated by: Ru Feng, Nanfang Hospital of Southern Medical University

A Multicentre, Randomized Phase III Study of Thalidomide Maintenance Treatment in Patients With Diffuse Large 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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

226

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Ru Feng
        • Contact:
        • Principal Investigator:
          • Ru Feng, M.D.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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,
  • 6 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Observation
Other: Observation
Just observation
Experimental: Thalidomide
Thalidomide 50mg daily by mouth( increase 50mg after 2 weeks if tolerated until 200mg/day) until disease progression or intolerance due to AEs.The dose could be reduced if the patient experienced grade 2 or higher AEs. Does reductions for AEs were recommended (200 mg daily to 100 mg daily, 100 mg daily to 50 mg daily).In patients intolerant of 50mg/day, thalidomide discontinuation was allowed.
Drug: Thalidomide
Thalidomide 50mg daily by mouth( increase 25mg after 2 weeks if tolerated Until 200mg/day) until disease progression or intolerance due to AEs.The dose could be reduced if patient experienced grade 2 or higher AEs. Does reductions for AEs were recommended (200 mg daily to 100 mg daily, 100 mg daily to 50 mg daily).In patients intolerant of 50mg/ day, thalidomide discontinuation was allowed.
Other Names:
  • Thalomid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relapse-free survival
Time Frame: 5 years
RFS was defined as the time between randomization and any documentation of relapse, death by any cause or last follow up.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 years
OS was defined as the interval from randomization to death or the last follow-up for surviving patients.
5 years
Incidence of treatment-emergent adverse events
Time Frame: 5 years
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).
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Investigators

  • Principal Investigator: Ru Feng, M.D., Department of Hematology, Nanfang Hospital, Southern Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2017

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

November 2, 2016

First Submitted That Met QC Criteria

January 7, 2017

First Posted (Estimate)

January 10, 2017

Study Record Updates

Last Update Posted (Actual)

July 28, 2017

Last Update Submitted That Met QC Criteria

July 26, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFL2016-B2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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