EUCTR2008-003729-18-IT
Active, not recruiting
Phase 1
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 diffuse large B cell lymphoma, not eligible for high-dose chemotherapy and autologous transplantation [Lenalidomide and DLBCL - ND
OSPEDALE S. RAFFAELE0 sites38 target enrollmentJune 13, 2008
Conditionspatients affected by diffused linfoma with big cellsMedDRA version: 9.1Level: LLTClassification code 10012818Term: Diffuse large B-cell lymphoma
DrugsREVLIMID
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- patients affected by diffused linfoma with big cells
- Sponsor
- OSPEDALE S. RAFFAELE
- Enrollment
- 38
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Age 65 years or younger 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 3 \- 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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range
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/L \- 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
Outcomes
Primary Outcomes
Not specified
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