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
Information provided by:
Florida Academic Dermatology Centers
First received: May 25, 2010
Last updated: May 27, 2010
Last verified: May 2010
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.
Cutaneous T Cell Lymphoma
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Open-label Phase 2 Pilot Study of Lenalidomide (Revlimid) as Adjuvant Treatment for Refractory Cutaneous T Cell Lymphoma
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2010 (Final data collection date for primary outcome measure)
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
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01132989
|Florida Academic Dermatology Center
|Miami, Florida, United States, 33136 |
|Contact: Annika M Grant, RN,MBA 305-324-2110 ext 210 firstname.lastname@example.org |
|Principal Investigator: Francisco A Kerdel, M.D. |
Florida Academic Dermatology Centers
||Francisco a Kerdel,M.D, Florida Academic Dermtology Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 25, 2010
||May 27, 2010
||United States: Food and Drug Administration
Keywords provided by Florida Academic Dermatology Centers:
Patients with cutaneous T cell lymphoma
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 28, 2016
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Immune System Diseases
Physiological Effects of Drugs
Angiogenesis Modulating Agents