Phase 2
N=48
Trial on Lenalidomide Given as Maintenance Therapy for Relapsed Diffuse Large B Cell Lymphoma
Diffuse Large B-cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00799513 ↗Enrolled (actual)
48
Serious AEs
25.0%
Results posted
Apr 2024
Primary outcome: Primary: 1-year Progression-free Survival — 31 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lenalidomide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- IRCCS San Raffaele
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 1-year Progression-free Survival |
31 | — |
| SECONDARY Progression Free Survival |
25 | — |
| SECONDARY Progression |
21 | — |
| SECONDARY Duration of Response |
29 | — |
| SECONDARY Overall Survival |
26 | — |
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
Eligibility Criteria
Inclusion Criteria
- Age > 65 years
- Age 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
Data sourced from ClinicalTrials.gov (NCT00799513). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.