Clinical trial · Interventional
Lenalidomide Plus ICE in the Treatment of Refractory and Relapsed DLBCL
A Phase II Study of the Efficacy and Safety of Lenalidomide Plus ICE in the Treatment of Refractory and Relapsed Diffuse Large B-cell Lymphoma
NCT03367143CI-TRIAL-00043953unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is to evaluate the efficacy and safety of Lenalidomide plus ICE in the treatment of Refractory and Relapsed DLBCL patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-Cell Lymphoma Refractory | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Ifosfamide | Drug | Ifosfamide | ALIAS |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- L-ICE
- description
- Lenalidomide 25mg/d po d1-10, Ifosfamide 1500mg/m2/d iv d1-3, Carboplatin 5\*\[GFR(ml/min)+25\]mg/d iv d2, Etoposide 100mg/m2/d iv d1-3, Frequency every 21 days, Total cycles 4
- interventionNames
- Drug: Lenalidomide
- Drug: Ifosfamide
- Drug: Carboplatin
- Drug: Etoposide
Primary outcomes (1)
- measure
- Complete response rate
- timeFrame
- 12 weeks
Secondary outcomes (4)
- measure
- Progression free survival rate
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically proven diffuse large B-cell lymphoma. Previously treated with 1, and only 1, chemotherapy regimen including rituximab and anthracycline. Relapse after CR, less than PR or PR to previous treatment. 2. No history of stem cell transplantation. 3. Age between 16-75. 4. ECOG\<3. 5. At least 1 measurable tumor mass. 6. Minimum life expectancy of 3 months. 7. Written informed consent. 8. No history of using Lenalidomide, ifosfamide, carboplatin and etoposide. 9. No uncontrolled CNS involvement by lymphoma:No CNS disease at time of relapse;CNS disease diagnosed at initial presentation allowed provided a complete response for CNS disease was achieved and maintained. Exclusion Criteria: 1. Chemotherapy or large field radiotherapy within 3 weeks prior to entering the study. 2. Clinically significant active infection. 3. Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule. 4. Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures. 5. Subject has ≥grade 2 peripheral neuropathy or grade 1 with pain within 14 days before enrollment. 6. Patients who are pregnant or breast-feeding. 7. HIV infection.
References
Publications (0)
Data not yet available
No reference posted for this study.