Cutaneous T Cell LymphomaPhase 2REvMM2009NCT01132989
Open-label Pilot Study of Lenalidomide (Revlimid) as Adjuvant Treatment for Refractory Cutaneous T Cell Lymphoma
A Phase 2 study testing Lenalidomide in people with Cutaneous T Cell Lymphoma, run by Florida Academic Dermatology Centers at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous T Cell Lymphoma
- What is being tested?
- Lenalidomide
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Dec 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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:
- has not undergone a hysterectomy or bilateral oophorectomy
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Florida Academic Dermatology Center
Miami, Florida, 33136
Annika M Grant, RN,MBA, 305-324-2110 ext. 210, annika@fadcenter.com
Francisco A Kerdel, M.D.
About this study
Official title: Open-label Phase 2 Pilot Study of Lenalidomide (Revlimid) as Adjuvant Treatment for Refractory Cutaneous T Cell Lymphoma
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
- Being tested
- Lenalidomide
- Keywords
- Patients with cutaneous T cell lymphoma
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year (average)
Secondary outcomes (3)
The assessment of patient-reported changes of pruritus during treatment
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.
Measured: 1 year (average)
The assessment of the patient-reported improvement in quality of life during treatment
The validated DLQI patient self assessment questionnaire will be used to quantify the impact of skin disease on patients' quality of life
Measured: 1 year (average)
The assessment of the safety and tolerability of lenalidomide in the study population
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.
Measured: 1 year (average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous T Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida Academic Dermatology Centers
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132989
- Sponsor's protocol ID
- RevMM2009
- Acronym
- REvMM2009
- Status last verified
- May 2010
- First submitted
- 25 May 2010
- Last updated
- 28 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Phase 2 Pilot Study of Lenalidomide (Revlimid) as Adjuvant Treatment for Refractory Cutaneous T Cell Lymphoma
- ClinicalTrials.gov ID
- NCT01132989
- Acronym / sponsor ID
- REvMM2009 / RevMM2009
- Conditions
- Cutaneous T Cell Lymphoma
- Keywords
- Patients with cutaneous T cell lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Florida Academic Dermatology CentersUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- May 2010
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 28 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LenalidomideLenalidomide 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 | Drug | – |
Primary outcome
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)
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.
3 secondary outcomes
The assessment of patient-reported changes of pruritus during treatment
Time frame: 1 year (average)
The assessment of the patient-reported improvement in quality of life during treatment
Time frame: 1 year (average)
The assessment of the safety and tolerability of lenalidomide in the study population
Time frame: 1 year (average)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lenalidomide in people with Cutaneous T Cell Lymphoma, run by Florida Academic Dermatology Centers at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francisco A Kerdel, M.D. (305 324 2110, dr.kerdel@fadcenter.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2010.