Trial on Lenalidomide Given as Maintenance Therapy for Relapsed Diffuse Large B Cell Lymphoma

NCT00799513 | Completed Phase 2 Results DMC

• 1 other identifier: 2008-003729-18
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II multi-institutional trial will explore the safety and efficacy of lenalidomide monotherapy given as maintenance therapy following salvage chemo-immunotherapy in patients with relapsed or refractory chemosensitive diffuse large B-cell lymphoma

Conditions

Diffuse Large B-cell Lymphoma

Keywords

Lenalidomide; revlimid; large B-cell lymphoma; relapse

Outcome Measures

Primary Outcomes (1)

• 1-year Progression-free Survival

  It is defined as the number of participants alive after 1 year from enrolment to progression or relapse of lymphoma (if post-induction disease status was PR (Partial Response) or CR (Complete Response), respectively). Patients alive at last follow-up will be censored.

  1-year

Secondary Outcomes (4)

• Progression Free Survival

  5 years

• Progression

  5 years

• Duration of Response

  5 years

• Overall Survival

  5 years

Study Arms (1)

Lenalidomide

EXPERIMENTAL

single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of disease.

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of disease.

Also known as: Revlimid

Lenalidomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 65 years
• Age \< 65 but not eligible to high-dose chemotherapy and autologous stem cell transplantation
• Biopsy-proven DLBCL relapsed to previous combination chemotherapy regimen ± rituximab
• PR (Partial Response) or CR (Complete Response) to second-line chemotherapy (ICE or DHAP/DHAOx or MINE regimen) + rituximab
• ECOG (Eastern Cooperative Oncology Group) performance status score \< 4
• Female of childbearing potential (FCBP) must demonstrate to practice a proper contraception to avoid any pregnancy risk during the study and at least 28 days after the discontinuation of the study
• Male subjects must agree to practice a proper contraception during any sexual contact with females childbearing potential

You may not qualify if:

• CNS (Central Nervous System) involvement
• Prior ASCT
• TTP (Time To Progression) \<6 months after first-line therapy
• Use of experimental drugs during second-line salvage chemotherapy
• Severe concomitant illnesses / medical conditions (e.g. impaired respiratory and/or cardiac function, uncontrolled diabetes mellitus )
• Active infectious disease
• HIV, HBV (Hepatitis B Virus) or HCV (Hepatitis C Virus) - positivity
• Impaired liver function (Bilirubin \>2 x upper normal limit; ALT (alanine aminotransferase) /AST (aspartate aminotransferase) /GGT (γ-glutamyltransferase) \> 3 x upper normal limit) at one month from salvage chemotherapy conclusion
• Impaired renal function (creatinine clearance \<50 ml/min) at one month from salvage chemotherapy conclusion
• Absolute neutrophil count (ANC) \<1000/microL
• Platelet count \<75.000 /mm3
• Hemoglobin \<9 g/dL
• Non-co-operative behaviour or non-compliance
• Psychiatric diseases or conditions that might impair the ability to give informed consent
• Pregnant or lactating females

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• Celgene: collaborator

Study Sites (1)

San Raffaele Scientific Institute

Milan, 20132, Italy

Location

Related Publications (2)

• Ferreri AJ, Sassone M, Zaja F, Re A, Spina M, Rocco AD, Fabbri A, Stelitano C, Frezzato M, Rusconi C, Zambello R, Couto S, Ren Y, Arcari A, Bertoldero G, Nonis A, Scarfo L, Calimeri T, Cecchetti C, Chiozzotto M, Govi S, Ponzoni M. Lenalidomide maintenance in patients with relapsed diffuse large B-cell lymphoma who are not eligible for autologous stem cell transplantation: an open label, single-arm, multicentre phase 2 trial. Lancet Haematol. 2017 Mar;4(3):e137-e146. doi: 10.1016/S2352-3026(17)30016-9. Epub 2017 Feb 17.

  PMID: 28219694 DERIVED

• Vose JM, Habermann TM, Czuczman MS, Zinzani PL, Reeder CB, Tuscano JM, Lossos IS, Li J, Pietronigro D, Witzig TE. Single-agent lenalidomide is active in patients with relapsed or refractory aggressive non-Hodgkin lymphoma who received prior stem cell transplantation. Br J Haematol. 2013 Sep;162(5):639-47. doi: 10.1111/bjh.12449. Epub 2013 Jul 9.

  PMID: 23834234 DERIVED

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Recurrence

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Principal Investigator
• Organization: San Raffaele Hospital IRCCS

ferreri.andres@hsr.it

0226437649

Study Officials

• Andrés J. Ferreri, MD

  San Raffaele Scientific Institute

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Unit Head

Study Record Dates

• First Submitted: November 20, 2008
• First Posted: December 1, 2008
• Study Start: March 1, 2009
• Primary Completion: March 1, 2017
• Study Completion: August 1, 2021
• Last Updated: April 10, 2024
• Results First Posted: April 9, 2024

Record last verified: 2024-04

Locations

IT (1)