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Open-label Pilot Study of Lenalidomide (Revlimid) as Adjuvant Treatment for Refractory Cutaneous T Cell Lymphoma (REvMM2009)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Florida Academic Dermatology Centers.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Celgene Corporation
Information provided by:
Florida Academic Dermatology Centers
ClinicalTrials.gov Identifier:
NCT01132989
First received: May 25, 2010
Last updated: May 27, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Cutaneous T Cell Lymphoma
Drug: Lenalidomide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-label Phase 2 Pilot Study of Lenalidomide (Revlimid) as Adjuvant Treatment for Refractory Cutaneous T Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Florida Academic Dermatology Centers:

Primary Outcome Measures:
  • Response rate(RR measurements are based on skin scoring using mSWAT (modified severity weighted assessment tool), Sezary cell count, and lymph node assessment. [ Time Frame: 1 year (average) ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • The assessment of patient-reported changes of pruritus during treatment [ Time Frame: 1 year (average) ] [ Designated as safety issue: No ]
    Descriptive statistics will be calculated for pruritus relief. Both median duration of pruritus relief (for those exhibiting improvement in pruritus) and time to pruritus relief will be estimated.

  • The assessment of the patient-reported improvement in quality of life during treatment [ Time Frame: 1 year (average) ] [ Designated as safety issue: No ]
    The validated DLQI patient self assessment questionnaire will be used to quantify the impact of skin disease on patients' quality of life

  • The assessment of the safety and tolerability of lenalidomide in the study population [ Time Frame: 1 year (average) ] [ Designated as safety issue: Yes ]
    The assessments of sezary cell count ,disease status using the mSWAT tool, lymphnode evaluations and adverse event incidences( associated with study medication )will be perfomed every four weeks to assess lenalidomide safety and tolerability.


Estimated Enrollment: 10
Study Start Date: May 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Lenalidomide
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
    • Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy.
    • A female of childbearing potential is a sexually mature woman who:

      1. has not undergone a hysterectomy or bilateral oophorectomy
      2. has not been naturally postmenopausal for at least 24 consecutive months (has had menses at any time in the preceding 24 consecutive months). See Appendix: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.
    • Disease free of prior malignancies for ≥ 5 years, with exception of basal cell and squamous cell carcinoma of the skin, or breast or cervix in situ carcinoma.
    • Expected survival of > 6 months.
    • Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation. Patients intolerant to aspirin may use warfarin or low molecular weight heparin.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01132989

Contacts
Contact: Francisco A Kerdel, M.D. 305 324 2110 dr.kerdel@fadcenter.com

Locations
United States, Florida
Florida Academic Dermatology Center Recruiting
Miami, Florida, United States, 33136
Contact: Annika M Grant, RN,MBA    305-324-2110 ext 210    annika@fadcenter.com   
Principal Investigator: Francisco A Kerdel, M.D.         
Sponsors and Collaborators
Florida Academic Dermatology Centers
Celgene Corporation
  More Information

No publications provided

Responsible Party: Francisco a Kerdel,M.D, Florida Academic Dermtology Center
ClinicalTrials.gov Identifier: NCT01132989     History of Changes
Other Study ID Numbers: RevMM2009
Study First Received: May 25, 2010
Last Updated: May 27, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Florida Academic Dermatology Centers:
Patients with cutaneous T cell lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Lenalidomide
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014