Status:
COMPLETED
Trial on Lenalidomide Given as Maintenance Therapy for Relapsed Diffuse Large B Cell Lymphoma
Lead Sponsor:
IRCCS San Raffaele
Collaborating Sponsors:
Celgene
Conditions:
Diffuse Large B-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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 combin...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2021
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00799513
Start Date
March 1 2009
End Date
August 1 2021
Last Update
April 10 2024
Active Locations (1)
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1
San Raffaele Scientific Institute
Milan, Italy, 20132