Back to results

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

Primary Purpose

Diffuse Large B-cell Lymphoma

Status

Unknown status

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

Lenalidomide

About this trial

This is an interventional treatment trial for Diffuse Large B-cell Lymphoma focused on measuring Lenalidomide, revlimid, large B-cell lymphoma, relapse

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 or CR to second-line chemotherapy (ICE or DHAP/DHAOx or MINE regimen) + rituximab
ECOG 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

Exclusion Criteria:

CNS involvement
Prior ASCT
TTP <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 or HCV- positivity
Impaired liver function (Bilirubin >2 x upper normal limit; ALT/AST/GGT > 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

Sites / Locations

San Raffaele Scientific InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lenalidomide

Arm Description

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.

Outcomes

Primary Outcome Measures

1-year progression-free survival

Secondary Outcome Measures

Median overall survival, response rate, response duration

Full Information

NCT ID

NCT00799513

First Posted

November 20, 2008

Last Updated

March 21, 2012

Sponsor

IRCCS San Raffaele

Collaborators

Celgene Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00799513

Brief Title

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

Official Title

A Phase II Trial to Evaluate the Safety and Activity of Single-agent Lenalidomide Given as Maintenance Therapy After Response to Second-line Therapy in Patients With Relapsed DLBCL, Not Eligible for High-dose Chemotherapy and ASCT

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Unknown status

Study Start Date

October 2009 (undefined)

Primary Completion Date

October 2013 (Anticipated)

Study Completion Date

November 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

IRCCS San Raffaele

Collaborators

Celgene Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

Detailed Description

Patients older than 65 years or younger but not eligible to high-dose chemotherapy and autologous stem cell transplantation with biopsy-proven diffuse large B-cell lymphoma relapsed to previous combination chemotherapy regimen ± rituximab, who achieved at least a partial response to second-line chemotherapy (ICE or DHAP/DHAOx or MINE regimen) + rituximab will receive single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment until progression of disease. Dose reductions of study drug will be made in case of adverse events when reported as correlated and when clinically appropriate. One-year progression free survival will be the primary endpoint and overall survival, response rate and toxicity will be the secondary endpoints. With the null hypothesis (P0) of 1-year PFS of 30%, this study will consider a satisfactory efficacy of lenalidomide worth of further investigation a P1 corresponding to a 1-yr PFS of 50% (that is an absolute increase of 20% in terms of 1-yr progression-free survival). Considering a standard type I error (α) of 0,05 and a power of 80% (Type 2 error of 20%) 47 patients will be necessary for the trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diffuse Large B-cell Lymphoma

Keywords

Lenalidomide, revlimid, large B-cell lymphoma, relapse

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

47 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lenalidomide

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Lenalidomide

Other Intervention Name(s)

Revlimid

Intervention Description

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.

Primary Outcome Measure Information:

Title

1-year progression-free survival

Time Frame

1-year

Secondary Outcome Measure Information:

Title

Median overall survival, response rate, response duration

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 or CR to second-line chemotherapy (ICE or DHAP/DHAOx or MINE regimen) + rituximab ECOG 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 Exclusion Criteria: CNS involvement Prior ASCT TTP <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 or HCV- positivity Impaired liver function (Bilirubin >2 x upper normal limit; ALT/AST/GGT > 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Andrés J. Ferreri, MD

Phone

0039-02-2643 7649

andres.ferreri@hsr.it

First Name & Middle Initial & Last Name or Official Title & Degree

Stefania Trinca

Phone

0039-02-2643 4289

stefania.trinca@hsr.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrés J. Ferreri, MD

Organizational Affiliation

San Raffaele Scientific Institute

Official's Role

Study Chair

Facility Information:

Facility Name

San Raffaele Scientific Institute

City

Milan

ZIP/Postal Code

20132

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Roberto Crocchiolo, MD

First Name & Middle Initial & Last Name & Degree

Silvia Govi, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

28219694

Citation

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.

Results Reference

derived

PubMed Identifier

23834234

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs