Open-label Pilot Study of Lenalidomide (Revlimid) as Adjuvant Treatment for Refractory Cutaneous T Cell Lymphoma

NCT01132989 | Unknown Phase 2 DMC

• 1 other identifier: RevMM2009
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with cutaneous T cell lymphoma experience refractory and progressive disease despite current treatment, necessitating chronic disease management. In addition, there needs to be greater emphasis on combination treatment, which correlates with increased response rate, more rapid onset of response, and decreased side effect profile compared to monotherapy. The goal for the use of Lenalidomide as an adjuvant treatment in patients with refractory cutaneous T cell lymphoma is to increase response rates, maintain a durable long-term response, relieve associated symptoms, and minimize toxic side effects.

Conditions

Cutaneous T Cell Lymphoma

Keywords

Patients with cutaneous T cell lymphoma

Outcome Measures

Primary Outcomes (1)

• Response rate(RR measurements are based on skin scoring using mSWAT (modified severity weighted assessment tool), Sezary cell count, and lymph node assessment.

  The primary efficacy measure is the response rate (RR) based on skin scoring using mSWAT (modified severity weighted assessment tool), Sezary cell count, and lymph node assessment. Response rate is defined as the number of responders divided by the number of treated patients. A responder is defined as any patient who exhibits a confirmed complete or partial response. • Patients will be treated until progressive disease is demonstrated by ≥ 25% increase of SWAT score.

  1 year (average)

Secondary Outcomes (3)

• The assessment of patient-reported changes of pruritus during treatment

  1 year (average)

• The assessment of the patient-reported improvement in quality of life during treatment

  1 year (average)

• The assessment of the safety and tolerability of lenalidomide in the study population

  1 year (average)

Interventions

Lenalidomide DRUG

Lenalidomide Starting Dose Based on Renal Function at Study Entry Baseline Calculated Creatinine Clearance (by Cockcroft-Gault) Starting Lenalidomide Dose 60 ml/min 25mg daily on Days 1-21 of each 28-day cycle 30 and \< 60 ml/min 10mg daily on Days 1-21 of each 28-day cycle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 years of age (at the time of signing the informed consent).
• Able to adhere to the study visit schedule and other protocol requirements.
• Histologically confirmed mycosis fungoides or Sezary syndrome
• Stage IB to IVB disease at screening (TNMB classification, see Protocol Attachment C)
• Refractory disease after at least 2 prior therapies, which may include topicals, phototherapy, bexarotene, interferon, and/or photopheresis. Patients may be currently taking these medication and therapies may be used in combination.
• Determined to have adequate baseline organ function defined as:
• Hepatic: Total bilirubin ≤ 1.5 x upper limit of normal (ULN),AST and ALT ≤ 3.0 x ULN
• Hematologic: Platelets ≥ 75 x 109/L
• Absolute neutrophil count (ANC) ≥ 1.0 x 109/L,Hemoglobin ≥ 8.0 mg/dL
• Renal: Creatinine clearance ≥ 30 ml/min (Appendix; Cockcroft-Gault formula)
• At least 3 months since the initiation of any new CTCL treatments.
• Stable or progressive disease despite current treatment regimen over the last 3 months.
• All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
• Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours prior to prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide.
• FCBP must also agree to ongoing pregnancy testing.

You may not qualify if:

• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
• Female subjects who are pregnant, nursing, or planning pregnancy. Female subjects not using at least 2 forms of birth control during the trial, unless the subject is considered sterile (history of hysterectomy or postmenopausal with no menses for the last 24 consecutive months).
• History of deep venous thrombus (DVT) or pulmonary embolism (PE), unless currently on anticoagulation therapy (warfarin or heparin).
• Subjects receiving chemotherapeutic agents (or have received in the last 3 months), vorinostat, or methotrexate.
• Use of any other experimental drug or therapy within 28 days of baseline.
• Known hypersensitivity to thalidomide.
• History of erythema nodosum or desquamating rash while taking thalidomide or similar drugs.
• Any prior use of lenalidomide.
• Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible..
• Having a serious concomitant systemic disorder that could preclude the patient from benefiting or completing the study based on discretion of the investigator.
• Any condition or circumstance judged by the investigator that would render the clinical trial detrimental or otherwise unsuitable for the patient's participation.
• Neuropathy \> grade 2

Sponsors & Collaborators

• Florida Academic Dermatology Centers: lead
• Celgene Corporation: collaborator

Study Sites (1)

Florida Academic Dermatology Center

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Francisco A Kerdel, M.D.

CONTACT

305 324 2110; dr.kerdel@fadcenter.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 25, 2010
• First Posted: May 28, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: May 28, 2010

Record last verified: 2010-05

Locations

US (1)