Cutaneous T Cell LymphomaPhase 4NCT00221039
Photopheresis as an Interventional Therapy for the Treatment of CTCL (Cutaneous T-Cell Lymphoma, Mycosis Fungoides) Stage 1A, 1B, 2A
A Phase 4 study testing Methoxsalen+ECP in people with Cutaneous T Cell Lymphoma and Mycosis Fungoides, run by M.D. Anderson Cancer Center at 7 sites in United States.
Trial summary
The study objective is to demonstrate that the UVADEX® Sterile Solution formulation of methoxsalen used in conjunction with the UVAR XTS Photopheresis System can have a clinical effect on the skin manifestations of CTCL (mycosis fungoides) in early stage disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous T Cell Lymphoma, Mycosis Fungoides
- What is being tested?
- Methoxsalen+ECP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 7 sitesUnited States
- Study dates
- 2 Apr 2004to 5 Apr 2011
- Phase
- Phase 4
- 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 are to be greater than 40 kg body weight.
- Patients must have adequate veins to provide intravenous access.
- Women who are not pregnant, lactating, or of childbearing potential. Lack of childbearing potential was defined as:
- Being post-menopausal
- Being surgically sterile
- Practicing contraception
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- Patients with childbearing potential had to have a negative serum human chorionic gonadotropin (HCG) upon entrance into the study.
- Patients must be willing to adhere to the protocol, and sign an Informed Patient Consent Form prior to entry into the study.
- Patients must not be on any other investigational device/drug treatment.
- Patients with the diagnosis of mycosis fungoides (MF) including a skin biopsy consistent with MF (atypical epidermotrophic or folliculocentric T-cells).
- Appropriate staging as IA, IB or IIA : T1 or T2 (patches or plaques) with measurable lesions.
- IA patients must show evidence of a minor blood abnormality by morphology or laboratory assessment.
- For IIA patients - clinically significant nodes (1.5 cm) must have lymph node biopsy showing dermatopathic nodes or no involvement.
- Patients must be willing and able to discontinue concomitant medications for MF.
- Patients currently taking the following drugs must discontinue medication prior to enrollment in the trial:
- Psoralens and ultraviolet A (PUVA) or ultraviolet B (UVB) therapy - 4 weeks
- Topical nitrogen mustard or other topical chemotherapy - 4 weeks
- Bexarotene capsules or other systemic biologic agent - 3 weeks washout
- High dose topical steroids, topical retinoids or immunotherapy - 2 week washout with 1% topical hydrocortisone
- Oral steroids above 10 mg - 30 day washout, unless patient has Addison's disease or adrenal insufficiency
- Patients must be refractory to at least one of the standard therapies used to treat Stage IA, IB or IIA CTCL such as oral steroids, high-dose topical steroids, mechlorethamine (HN2), bexarotene, PUVA therapy, electron beam radiation, biological response or oral methotrexate.
- Patients must abstain from therapeutic sunbathing, tanning beds, etc. for the duration of the study.
Who cannot join
- Patients who have MF (T3 cutaneous tumors or T4 exfoliative erythroderma) Stage IIB - IVB, ie. no pathological node or visceral involvement.
- Patients who are unable to tolerate extracorporeal volume loss (e.g., severe cardiac disease or severe anemia or weight < 40 kg).
- Patients with recent (within three months) deterioration of renal function who have a serum creatinine level greater than 3.0 mg/dL.
- Patients with lipemic plasma > 500 ng/dL or uncontrolled diabetes.
- Patients with a history of liver damage (2.5 x normal ALT, AST) or porphyria.
- Patients with positive tests for HIV antibody, hepatitis C virus (HCV) antibody or hepatitis B surface antigen.
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- Patients on oral prednisone therapy or full body or high potency topical steroids.
- Women who are pregnant or nursing a child.
- Patients with severe emotional, behavioral or psychiatric problems that, in the opinion of the investigator, would result in poor compliance with the treatment regimen.
- Patients who exhibit idiosyncratic or hypersensitivity reactions to 8-methoxypsoralen compounds, heparin, or citrate.
- Patients with previous exposure to photopheresis therapy.
- Patients who use tanning beds or are receiving phototherapy.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Boston Medical Center
Boston, Massachusetts, 02118
Rush-Presbyterian Hospital
Chicago, Illinois, 60612
University Hospital of Cleveland/Case Western Reserve University
Cleveland, Ohio, 44106
MD Anderson Cancer Center
Houston, Texas, 77030
University of Minnesota
Minneapolis, Minnesota, 55455
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: UVADEX Sterile Solution in Conjunction With the UVAR XTS Photopheresis System as an Interventional Therapy for the Treatment Of CTCL (Mycosis Fungoides) in Patients With TMN Classification Stage 1A, 1B, 2A
The study objective is to demonstrate that the UVADEX® Sterile Solution formulation of methoxsalen used in conjunction with the UVAR XTS Photopheresis System can have a clinical effect on the skin manifestations of CTCL (mycosis fungoides) in early stage disease.
Read the detailed description
Objectives: The study objective is to demonstrate that the UVADEX® Sterile Solution formulation of methoxsalen used in conjunction with the UVAR XTS Photopheresis System can have a clinical effect on the skin manifestations of CTCL (mycosis fungoides) in early stage disease.
Methodology: Single-arm, open-label treatment using UVAR XTS Photopheresis System. Treatment consists of two photopheresis treatments on successive days every 4 weeks for six months. Those patients completing the first 6-month period may be continued on photopheresis for a 6-month follow-up period. Patients who do not respond to photopheresis therapy after 6 months may have concurrent therapy with low dose bexarotene and interferon added as outlined in the protocol.
Number of Patients (Planned and Analyzed): The study plan is for a minimum of 50 patients
Diagnosis and Main Criteria for Inclusion: Male or female patients with CTCL diagnosis of stage IA, IB or IIA with measurable skin lesions (patches or plaques) and a minor blood abnormality. Patients must be refractory to at least one treatment for early stage CTCL such as PUVA, Electron beam, oral steroids, high potency topical steroid, topical nitrogen mustard, methotrexate, interferon, or bexarotene.
Test Product, Dose and Mode of Administration, Batch or Lot Number: UVADEX liquid methoxsalen 20mcg/mL in conjunction with the UVAR XTS Photopheresis System. UVADEX is injected into the photoactivation bag during photopheresis therapy in accordance with the approved drug package insert and UVAR XTS operator's manual. UVADEX dose is less than 200mcg per treatment.
Duration of Treatment: The study will consist of 2 treatment periods, a 6-month initial period and a 6-month follow-up period where photopheresis therapy may continue.
Criteria for Evaluation:
Efficacy: The primary endpoint will be the overall response based on skin-weighted assessment. Secondary endpoints will also include time to response, duration of response, and a "Quality of Life " assessment. The size and number of lymph nodes and flow cytometry analyses will also be considered. Experienced skin observers will perform skin scores on each patient at enrollment. Skin scores will be recorded as the percentage of the patient's body involved with patch or plaque lesions. A successful response to therapy will be patients who have a greater than 50% improvement in skin involvement (PR) or complete skin improvement (CR) without worsening in nodes, blood or visceral organs. Patients with 25%-50% improvement will be considered as minor response (MR), + or - 25% will be SD, and PD will be defined as 25% worsening from baseline.
Safety: Safety is assessed by the incidence and intensity of adverse events, whether clinical or based on laboratory results.
Statistical Methods: The primary endpoint will be the proportion of patients who have CR and PR of their skin lesions.
- Conditions
- Cutaneous T Cell Lymphoma, Mycosis Fungoides
- Being tested
- Methoxsalen+ECP
- Keywords
- ECP, Photopheresis, CTCL, Cutaneous T Cell Lymphoma, Mycosis Fungoides
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methoxsalen+ECPDrug
Also called Uvadex
UVAdex+ECP will be administered: Treatment consists of two photopheresis treatments on successive days every 4 weeks for six months
| Study group | Role | What they receive |
|---|---|---|
| DRUG+ECP | Experimental | UVVADEX +ECP will be administered to patients with CTCL.Duration of Treatment: The study will consist of 2 treatment periods, a 6-month initial period and a 6-month follow-up period where photopheresis therapy may continue. Receives: Drug: Methoxsalen+ECP |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be the overall response based on skin-weighted assessment.
The overall skin repsonse will be assessed at 6month and will consist of an experts assessment of the % of skin involvement at baseline and 6 months.
Measured: 6 months
Secondary outcomes (1)
Quality of life assessed by questionnaire
A quality of life questionnaire will be completed by the patient at 6 months of treatment and 6 months after end of treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study start2 Apr 2004
- Primary completion5 Apr 2011
- Study completion5 Apr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cutaneous T Cell LymphomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Medical Center, University of Pittsburgh, Case Western Reserve University, Vanderbilt University Medical Center, University of Minnesota, Rush University Medical Center, Mallinckrodt
- Responsible party
- Sponsor
- Investigators
- Madeleine Duvic, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221039
- Sponsor's protocol ID
- ECTCL1
- Status last verified
- Aug 2018
- First submitted
- 13 Sep 2005
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Talpur R, Demierre MF, Geskin L, Baron E, Pugliese S, Eubank K, Zic JA, Miller DR, Tharp M, Bohjanen K, Duvic M. Multicenter photopheresis intervention trial in early-stage mycosis fungoides. Clin Lymphoma Myeloma Leuk. 2011 Apr;11(2):219-27. doi: 10.1016/j.clml.2011.03.003. Epub 2011 Apr 8.
PubMed 21575927
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UVADEX Sterile Solution in Conjunction With the UVAR XTS Photopheresis System as an Interventional Therapy for the Treatment Of CTCL (Mycosis Fungoides) in Patients With TMN Classification Stage 1A, 1B, 2A
- ClinicalTrials.gov ID
- NCT00221039
- Acronym / sponsor ID
- ECTCL1
- Conditions
- Cutaneous T Cell Lymphoma, Mycosis Fungoides
- Keywords
- ECP, Photopheresis, CTCL, Cutaneous T Cell Lymphoma, Mycosis Fungoides
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Boston Medical Center, University of Pittsburgh, Case Western Reserve University, Vanderbilt University Medical Center, University of Minnesota, Rush University Medical Center, Mallinckrodt
- Study start
- 2 Apr 2004 (actual)
- Primary completion
- 5 Apr 2011 (actual)
- Study completion
- 5 Apr 2011 (actual)
- First posted
- 22 Sep 2005 (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.
The study objective is to demonstrate that the UVADEX® Sterile Solution formulation of methoxsalen used in conjunction with the UVAR XTS Photopheresis System can have a clinical effect on the skin manifestations of CTCL (mycosis fungoides) in early stage disease.
Detailed description
Objectives: The study objective is to demonstrate that the UVADEX® Sterile Solution formulation of methoxsalen used in conjunction with the UVAR XTS Photopheresis System can have a clinical effect on the skin manifestations of CTCL (mycosis fungoides) in early stage disease.
Methodology: Single-arm, open-label treatment using UVAR XTS Photopheresis System. Treatment consists of two photopheresis treatments on successive days every 4 weeks for six months. Those patients completing the first 6-month period may be continued on photopheresis for a 6-month follow-up period. Patients who do not respond to photopheresis therapy after 6 months may have concurrent therapy with low dose bexarotene and interferon added as outlined in the protocol.
Number of Patients (Planned and Analyzed): The study plan is for a minimum of 50 patients
Diagnosis and Main Criteria for Inclusion: Male or female patients with CTCL diagnosis of stage IA, IB or IIA with measurable skin lesions (patches or plaques) and a minor blood abnormality. Patients must be refractory to at least one treatment for early stage CTCL such as PUVA, Electron beam, oral steroids, high potency topical steroid, topical nitrogen mustard, methotrexate, interferon, or bexarotene.
Test Product, Dose and Mode of Administration, Batch or Lot Number: UVADEX liquid methoxsalen 20mcg/mL in conjunction with the UVAR XTS Photopheresis System. UVADEX is injected into the photoactivation bag during photopheresis therapy in accordance with the approved drug package insert and UVAR XTS operator's manual. UVADEX dose is less than 200mcg per treatment.
Duration of Treatment: The study will consist of 2 treatment periods, a 6-month initial period and a 6-month follow-up period where photopheresis therapy may continue.
Criteria for Evaluation:
Efficacy: The primary endpoint will be the overall response based on skin-weighted assessment. Secondary endpoints will also include time to response, duration of response, and a "Quality of Life " assessment. The size and number of lymph nodes and flow cytometry analyses will also be considered. Experienced skin observers will perform skin scores on each patient at enrollment. Skin scores will be recorded as the percentage of the patient's body involved with patch or plaque lesions. A successful response to therapy will be patients who have a greater than 50% improvement in skin involvement (PR) or complete skin improvement (CR) without worsening in nodes, blood or visceral organs. Patients with 25%-50% improvement will be considered as minor response (MR), + or - 25% will be SD, and PD will be defined as 25% worsening from baseline.
Safety: Safety is assessed by the incidence and intensity of adverse events, whether clinical or based on laboratory results.
Statistical Methods: The primary endpoint will be the proportion of patients who have CR and PR of their skin lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DRUG+ECP | Experimental | Drug: Methoxsalen+ECPUVVADEX +ECP will be administered to patients with CTCL.Duration of Treatment: The study will consist of 2 treatment periods, a 6-month initial period and a 6-month follow-up period where photopheresis therapy may continue. |
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 are to be greater than 40 kg body weight.
- Patients must have adequate veins to provide intravenous access.
- Women who are not pregnant, lactating, or of childbearing potential. Lack of childbearing potential was defined as:
- Patients with childbearing potential had to have a negative serum human chorionic gonadotropin (HCG) upon entrance into the study.
- Patients must be willing to adhere to the protocol, and sign an Informed Patient Consent Form prior to entry into the study.
Key exclusion criteria (12 listed)
- Patients who have MF (T3 cutaneous tumors or T4 exfoliative erythroderma) Stage IIB - IVB, ie. no pathological node or visceral involvement.
- Patients who are unable to tolerate extracorporeal volume loss (e.g., severe cardiac disease or severe anemia or weight < 40 kg).
- Patients with recent (within three months) deterioration of renal function who have a serum creatinine level greater than 3.0 mg/dL.
- Patients with lipemic plasma > 500 ng/dL or uncontrolled diabetes.
- Patients with a history of liver damage (2.5 x normal ALT, AST) or porphyria.
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 |
|---|---|---|
| Methoxsalen+ECPAlso: UvadexUVAdex+ECP will be administered: Treatment consists of two photopheresis treatments on successive days every 4 weeks for six months | Drug | DRUG+ECP |
Primary outcome
The primary endpoint will be the overall response based on skin-weighted assessment.
Time frame: 6 months
The overall skin repsonse will be assessed at 6month and will consist of an experts assessment of the % of skin involvement at baseline and 6 months.
1 secondary outcome
Quality of life assessed by questionnaire
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
- Results publication: PubMed 21575927Talpur R, Demierre MF, Geskin L, Baron E, Pugliese S, Eubank K, Zic JA, Miller DR, Tharp M, Bohjanen K, Duvic M. Multicenter photopheresis intervention trial in early-stage mycosis fungoides. Clin Lymphoma Myeloma Leuk. 2011 Apr;11(2):219-27. doi: 10.1016/j.clml.2011.03.003. Epub 2011 Apr 8.
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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.
Madeleine Duvic, MD principal investigator
M.D. Anderson Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methoxsalen+ECP in people with Cutaneous T Cell Lymphoma and Mycosis Fungoides, run by M.D. Anderson Cancer Center at 7 sites 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: finished, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint will be the overall response based on skin-weighted assessment. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00221039, which also lists 1 linked publication.
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 17 Aug 2018.