Thalidomide Maintenance Treatment in DLBCL

Lymphoma, Large B-Cell, Diffuse Clinical Trial

Official title:

A Multicentre, Randomized Phase III Study of Thalidomide Maintenance Treatment in Patients With Diffuse Large B-cell Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03016000
• Other study ID #: NFL2016-B2
• Status: Recruiting
• Phase: Phase 3
• First received: November 2, 2016
• Last updated: July 26, 2017
• Start date: July 26, 2017
• Est. completion date: December 2023

Study information

• Verified date: July 2017
• Source: Nanfang Hospital of Southern Medical University
• Contact: Ru Feng, M.D.
• Phone: 86-20-61641613
• Email: ruth1626[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 226
• Est. completion date: December 2023
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Large B-Cell, Diffuse

Intervention

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:
• Observation
Just observation

Locations

Country	Name	City	State
China	Ru Feng	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

References & Publications (9)

Avilés A, Cleto S, Huerta-Guzmán J, Neri N. Interferon alfa 2b as maintenance therapy in poor risk diffuse large B-cell lymphoma in complete remission after intensive CHOP-BLEO regimens. Eur J Haematol. 2001 Feb;66(2):94-9. — View Citation

Chaganti S, Illidge T, Barrington S, Mckay P, Linton K, Cwynarski K, McMillan A, Davies A, Stern S, Peggs K; British Committee for Standards in Haematology. Guidelines for the management of diffuse large B-cell lymphoma. Br J Haematol. 2016 Jul;174(1):43-56. doi: 10.1111/bjh.14136. Epub 2016 May 16. — View Citation

Crump M, Leppä S, Fayad L, Lee JJ, Di Rocco A, Ogura M, Hagberg H, Schnell F, Rifkin R, Mackensen A, Offner F, Pinter-Brown L, Smith S, Tobinai K, Yeh SP, Hsi ED, Nguyen T, Shi P, Hahka-Kemppinen M, Thornton D, Lin B, Kahl B, Schmitz N, Savage KJ, Habermann T. Randomized, Double-Blind, Phase III Trial of Enzastaurin Versus Placebo in Patients Achieving Remission After First-Line Therapy for High-Risk Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2016 Jul 20;34(21):2484-92. doi: 10.1200/JCO.2015.65.7171. Epub 2016 May 23. — View Citation

Gisselbrecht C, Schmitz N, Mounier N, Singh Gill D, Linch DC, Trneny M, Bosly A, Milpied NJ, Radford J, Ketterer N, Shpilberg O, Dührsen U, Hagberg H, Ma DD, Viardot A, Lowenthal R, Brière J, Salles G, Moskowitz CH, Glass B. Rituximab maintenance therapy after autologous stem-cell transplantation in patients with relapsed CD20(+) diffuse large B-cell lymphoma: final analysis of the collaborative trial in relapsed aggressive lymphoma. J Clin Oncol. 2012 Dec 20;30(36):4462-9. doi: 10.1200/JCO.2012.41.9416. Epub 2012 Oct 22. — View Citation

Ji D, Li Q, Cao J, Guo Y, Lv F, Liu X, Wang B, Wang L, Luo Z, Chang J, Wu X, Hong X. Thalidomide enhanced the efficacy of CHOP chemotherapy in the treatment of diffuse large B cell lymphoma: A phase II study. Oncotarget. 2016 May 31;7(22):33331-9. doi: 10.18632/oncotarget.8973. — View Citation

Maiolino A, Hungria VT, Garnica M, Oliveira-Duarte G, Oliveira LC, Mercante DR, Miranda EC, Quero AA, Peres AL, Barros JC, Tanaka P, Magalhães RP, Rego EM, Lorand-Metze I, Lima CS, Renault IZ, Braggio E, Chiattone C, Nucci M, de Souza CA; Brazilian Multiple Myeloma Study Group (BMMSG/GEMOH). Thalidomide plus dexamethasone as a maintenance therapy after autologous hematopoietic stem cell transplantation improves progression-free survival in multiple myeloma. Am J Hematol. 2012 Oct;87(10):948-52. doi: 10.1002/ajh.23274. Epub 2012 Jun 23. — View Citation

Michallet AS, Lebras L, Coiffier B. Maintenance therapy in diffuse large B-cell lymphoma. Curr Opin Oncol. 2012 Sep;24(5):461-5. doi: 10.1097/CCO.0b013e3283562036. Review. — View Citation

Spencer A, Prince HM, Roberts AW, Prosser IW, Bradstock KF, Coyle L, Gill DS, Horvath N, Reynolds J, Kennedy N. Consolidation therapy with low-dose thalidomide and prednisolone prolongs the survival of multiple myeloma patients undergoing a single autologous stem-cell transplantation procedure. J Clin Oncol. 2009 Apr 10;27(11):1788-93. doi: 10.1200/JCO.2008.18.8573. Epub 2009 Mar 9. — View Citation

Witzens-Harig M, Benner A, McClanahan F, Klemmer J, Brandt J, Brants E, Rieger M, Meissner J, Hensel M, Neben K, Dreger P, Lengfelder E, Schmidt-Wolf I, Krämer A, Ho AD. Rituximab maintenance improves survival in male patients with diffuse large B-cell lymphoma. Results of the HD2002 prospective multicentre randomized phase III trial. Br J Haematol. 2015 Dec;171(5):710-9. doi: 10.1111/bjh.13652. Epub 2015 Oct 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse-free survival	RFS was defined as the time between randomization and any documentation of relapse, death by any cause or last follow up.	5 years
Secondary	Overall survival	OS was defined as the interval from randomization to death or the last follow-up for surviving patients.	5 years
Secondary	Incidence of treatment-emergent adverse events	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