Clinical trial · Interventional
Lenalidomide in Treating Patients With Relapsed Mycosis Fungoides/Sezary Syndrome
Phase II Trial of CC-5013 (Lenalidomide, Revlimid®) in Patients With Cutaneous T-Cell Lymphoma
NCT00466921CI-TRIAL-00048576completedPhase 2Results postedClinicalTrials.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)
RATIONALE: Lenalidomide may stop the growth of mycosis fungoides/Sezary syndrome by blocking blood flow to the cancer. PURPOSE: This phase II trial is studying how well lenalidomide works in treating patients with relapsed mycosis fungoides/Sezary syndrome.
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 |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lenalidomide | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lenalidomide
- interventionNames
- Drug: lenalidomide
Primary outcomes (3)
- measure
- Response to Treatment
- timeFrame
- After cycle 4 of treatment (1 cycle =28 days)
- description
- In general response to treatment is defined as either complete response (CR) or partial response (PR) assessed using Composite Assessment (CA) of index lesion disease severity and is defined as the following: CR =CA ratio=0/no evidence of new disease (abnormal or pathologically positive lymph nodes, cutaneous or other tumor manifestations, visceral disease) present over 4 weeks. Patients with Sézary Syndrome must have no evidence of circulating Sézary cells (\< 5% Sézary cells=not significant). Skin biopsy is required for documentation of CR. Confirmatory CT scans are required, if baseline CTs were abnormal. PR= CA ratio ≥0.5/no new clinically abnormal lymph nodes/no progression of existing clinically abnormal lymph nodes (\<25%)/no new cutaneous tumors/no new pathologically positive lymph nodes or visceral disease in an area previously documented as-ve for at least 4 weeks. In patients with circulating Sézary cells at least a 50% reduction of malignant lymphocytes is required.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed mycosis fungoides/Sézary syndrome * Stage IA-IVB disease * Must have failed ≥ 1 prior topical treatment, including any of the following: * Steroids * Nitrogen mustard * Retinoids * Phototherapy * Photochemotherapy * Radiotherapy * Total skin electron beam * Measurable disease with ≥ 1 indicator lesion designated prior to study entry * Erythrodermic patients are eligible PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * WBC ≥ 3,000/mm³ * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Creatinine ≤ 2.0 mg/dL * Bilirubin ≤ 2.2 mg/dL * AST and ALT ≤ 2 times upper limit of normal * Not pregnant or nursing * Negative pregnancy test * Fertile women must use effective double-method contraception for ≥ 4 weeks before, during, and for ≥ 4 weeks after completion of study therapy * Fertile men must use effective contraception during and for ≥ 4 weeks after completion of study therapy * No other malignancy within the past 5 years except treated squamous cell and basal cell carcinoma of the skin, carcinoma in situ of the cervix, or surgically removed melanoma in situ of the skin (stage 0), with histologically confirmed free margins of excision and no current evidence of disease * No acute infection requiring systemic treatment * No known allergic reaction or hypersensitivity to thalidomide PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 4 weeks since prior topical therapy, systemic chemotherapy, or biological therapy * No prior stem cell transplantation * No other concurrent systemic antipsoriatic or anticancer therapies, including radiotherapy, thalidomide, or other investigational agents * No other concurrent topical agents except emollients
References
Publications (1)
- DERIVEDQuerfeld C, Rosen ST, Guitart J, Duvic M, Kim YH, Dusza SW, Kuzel TM. Results of an open-label multicenter phase 2 trial of lenalidomide monotherapy in refractory mycosis fungoides and Sezary syndrome. Blood. 2014 Feb 20;123(8):1159-66. doi: 10.1182/blood-2013-09-525915. Epub 2013 Dec 11. PMID 24335103