A phase III study of lenalidomide maintenance after debulking therapy in patients with advanced cutaneous T-cell lymphoma.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-011020-65-DE

Enrollment

105

Registered

2010-01-18

Start date

2011-02-25

Completion date

Unknown

Last updated

2020-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous T-cell lymphoma: Mycosis Fungoides, Stage IIB to IV or Sézary Syndrome MedDRA version: 14.1 Level: LLT Classification code 10028508 Term: Mycosis fungoides/Sezary syndrome System Organ Class: 100000004864

Interventions

Trade Name: Revlimid Pharmaceutical Form: Capsule, hard INN or Proposed INN: LENALIDOMIDE CAS Number: 191732-72-6 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Advanced stage mycosis fungoides (stage IIB-IV), or Sézary Syndrome. ? Prior debulking therapy with either mono-chemotherapy, Poly-chemotherapy/combination chemo and radiotherapy or radiotherapy alone (e.g. Total Skin Electron Beam body radiation [TSEB]) (according to local institutional guidelines) resulting in complete or partial response as defined in this protocol's "Evaluation criteria" chapter. At the time of registration, patients provide consent for the collection of this pre/post debulking assessment information. ? For patients with Sézary syndrome, Sézary cell burden has to be decreased by at least 50 percent after debulking. ? Local low-dose/energy ionizing radiation therapy may be used as part of the debulking process in combination with chemotherapy. ? High dose steroids may be used as part of the debulking regimen as per local institution protocols, but must have been discontinued by the end of debulking and at the time of disease response assessment. ? Disease not appropriate for skin-directed therapy, per local institution standards. ? Disease not previously treated with intravenous anti-neoplastic agents (except for the debulking agents, used for that purpose immediately prior to this protocol). ? Age > 18 years. ? WHO performance status 0-2. ? Life expectance greater than 12 months. ? Patients with high risk for or history of a thromboembolic event must agree to receive prophylactic anti-coagulation therapy to keep the International normalized ratio (INR) in the range of 2-3. ? No second malignancies in the 3 years prior to study entry with the exception of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, and basal/squamous cell carcinoma of the skin. ? Female subjects of childbearing potential (as defined in the protocol) must agree to use an appropriate form of contraception, as defined in chapter 3 'Patient seclection criteria'. ? Male subjects must agree to use condoms throughout study drug therapy and follow guidelines, as described in chapter 3 'Patient seclection criteria'. ? Written informed consent must be given according to the International Conference on Harmonisation (ICH) Harmonized Tripartite Guideline on Good Clinical Practice (ICH/GCP), and national/local regulations. 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 55 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: ? Central nervous system involvement. ? Uncontrolled infectious disease, autoimmune disease, immunodeficiency, or history of either splenectomy or splenic irradiation. ? No pregnant or breast feeding subjects. ? No Lapp lactase deficiency or history of glucose-galactose malabsorption. ? Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Design outcomes

Primary

Measure	Time frame
Main Objective: The overall objective is to determine if maintenance treatment with lenalidomide prolongs response after debulking in patients with advanced stage CTCL who have not been previously treated with intravenous chemotherapy except the chemotherapy received in the preceeding debulking stage. Patients will be randomized to either receive the maintenance therapy or not, and these two study arms will be compared in terms of the difference in progression free survival (PFS).;Secondary Objective: The secondary objectives assess: -overall survival; -progression free survival as assessed by hematogenous disease criteria (see chapter 7); -acute and late toxicity; -conversion rate; - and, rate of occurrence of second cancers at any site. Additional secondary objectives are translational research-related and include: -to advance understanding of cutaneous T-cell lymphoma itself, as well as its response to treatment with maintenance lenalidomide; -to allow collection and storage of biological material from patients enrolled in this study for use in future translational research studies;Primary end point(s): Progression free (PF) survival (PFS);Timepoint(s) of evaluation of this end point: Timepoint(s) of evaluation of the primary end point: "Progression-free survival (PFS)" Futility analysis based on PFS will take place at approximately 30 months after the first patient randomized. The final analysis will take place at approximately 62 months after the first patient randomized. The interim analysis (IA) will be conducted when 33.7% of information is available (30 events). Assuming the above accrual rate (2 pts/per month), the IA is expected to take place 27 months after the first patient randomized or around 51 patients accrued. The IA Report is confidential and will be reviewed by the IDMC which will make a recommendation to continue or stop the study based on the IA.	—

Measure

Time frame

Main Objective: The overall objective is to determine if maintenance treatment with lenalidomide prolongs response after debulking in patients with advanced stage CTCL who have not been previously treated with intravenous chemotherapy except the chemotherapy received in the preceeding debulking stage. Patients will be randomized to either receive the maintenance therapy or not, and these two study arms will be compared in terms of the difference in progression free survival (PFS).;Secondary Objective: The secondary objectives assess: -overall survival; -progression free survival as assessed by hematogenous disease criteria (see chapter 7); -acute and late toxicity; -conversion rate; - and, rate of occurrence of second cancers at any site. Additional secondary objectives are translational research-related and include: -to advance understanding of cutaneous T-cell lymphoma itself, as well as its response to treatment with maintenance lenalidomide; -to allow collection and storage of biological material from patients enrolled in this study for use in future translational research studies;Primary end point(s): Progression free (PF) survival (PFS);Timepoint(s) of evaluation of this end point: Timepoint(s) of evaluation of the primary end point: "Progression-free survival (PFS)" Futility analysis based on PFS will take place at approximately 30 months after the first patient randomized. The final analysis will take place at approximately 62 months after the first patient randomized. The interim analysis (IA) will be conducted when 33.7% of information is available (30 events). Assuming the above accrual rate (2 pts/per month), the IA is expected to take place 27 months after the first patient randomized or around 51 patients accrued. The IA Report is confidential and will be reviewed by the IDMC which will make a recommendation to continue or stop the study based on the IA.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints include overall survival, PFS, acute and late toxicity, conversion rate, and rate of occurrence of second cancers at any site. Additionally, translational research objectives are: - To advance the understanding of cutaneous T-cell lymphoma itself, as well as its response to treatment with maintenance lenalidomide. - Allow the collection and storage of biological material from patients enrolled in this study for use in future translational research studies.;Timepoint(s) of evaluation of this end point: Secondary endpoints will be analyzed at the same time as the primary endpoint analyses; this will be done whenever the study is mature for the primary endpoint analysis.	—

Measure

Time frame

Secondary end point(s): Secondary endpoints include overall survival, PFS, acute and late toxicity, conversion rate, and rate of occurrence of second cancers at any site. Additionally, translational research objectives are: - To advance the understanding of cutaneous T-cell lymphoma itself, as well as its response to treatment with maintenance lenalidomide. - Allow the collection and storage of biological material from patients enrolled in this study for use in future translational research studies.;Timepoint(s) of evaluation of this end point: Secondary endpoints will be analyzed at the same time as the primary endpoint analyses; this will be done whenever the study is mature for the primary endpoint analysis.

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Countries

Austria, Belgium, Denmark, Finland, France, Germany, Netherlands, Spain, Switzerland, United Kingdom

Contacts

Public ContactProject - Budget & Regulatory Dept

European Organisation for the Research and Treatment of Cancer

regulatory@eortc.be+3227741054

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026