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

Sponsor

IRCCS San Raffaele (Other)

Overall Status

Unknown status

CT.gov ID

NCT00799513

Collaborator

Celgene Corporation (Industry)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Diffuse Large B-cell Lymphoma	Drug: Lenalidomide	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

47 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Oct 1, 2009

Anticipated Primary Completion Date :

Oct 1, 2013

Anticipated Study Completion Date :

Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lenalidomide 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 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. Other Names: Revlimid

Arm

Intervention/Treatment

Experimental: Lenalidomide

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

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.

Other Names:

Revlimid

Outcome Measures

Primary Outcome Measures

1-year progression-free survival [1-year]

Secondary Outcome Measures

Median overall survival, response rate, response duration [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts 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