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
65 Years
N/A
Both
Diffuse Large B-cell Lymphoma
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
1-year progression-free survival
Outcome Time Frame:
1-year
Safety Issue:
Yes
Principal Investigator
Andrés J. Ferreri, MD
Investigator Role:
Study Chair
Investigator Affiliation:
San Raffaele Scientific Institute
Authority:
Italy: Ministry of Health
Study ID:
2008-003729-18
NCT ID:
NCT00799513
Start Date:
October 2009
Completion Date:
November 2013
Related Keywords:
- Diffuse Large B-Cell Lymphoma
- Lenalidomide
- revlimid
- large B-cell lymphoma
- relapse
- Lymphoma
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
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