Mycosis FungoidesPhase 1NCT02822586
TSEB and Brentuximab for Treatment of Mycosis Fungoides & Sezary Syndrome
A Phase 1 study testing TSEB Therapy and Brentuximab vedotin in people with Mycosis Fungoides and Sézary Syndrome, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the cutaneous toxicity and treatment response associated with administering concurrent TSEB and brentuximab vedotin in patients with mycosis fungoides or Sézary Syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mycosis Fungoides, Sézary Syndrome
- What is being tested?
- TSEB Therapy and Brentuximab vedotin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2016to 29 Apr 2019
- Phase
- Phase 1
- 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
- Histologically confirmed CD30-positive (defined in this study as ≥ 1% expression) Mycosis Fungoides (including large cell transformation variant) or Sezary Syndrome who have either:
- Received prior systemic therapy (for whom commercial supply of brentuximab vedotin is available) OR
- Not received prior systemic therapy (who will receive brentuximab vedotin free of charge)
- Any of the disease stages listed below
- Stage IB disease that meets one of the following criteria:
- Plaque disease (ie,T2b staging)
Show all 31Show fewer
- Diffuse skin involvement with indication for TSEB (plaque disease with or without patches)
- Not appropriate for treatment with focal therapies
- One prior course of low-dose TSEB or one prior course of systemic chemotherapy regimens (excluding brentuximab)
- Stage IIA, IIB, or IIIA that meets ONE or BOTH of the following criteria:
- Patient is a candidate for treatment with low-dose TSEB
- Patient is a candidate for systemic therapy
- IIIB or IVA disease requiring systemic therapy
- Transformed CTCL
- Candidate for TSEB based on investigator determination
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2, or 3, if the performance status of 3 is due to skin disease involvement
- Adequate bone marrow function as defined below:
- Absolute neutrophil count (ANC) ≥ 1000/mm3
- Platelets > 75,000/mm3
- Hemoglobin ≥ 9 g/dL
- Note: Patients requiring transfusion to meet the hemoglobin requirement are not eligible for the study.
- Calculated creatinine clearance (CrCl) > 30 mL/min.
- Adequate hepatic function as defined below:
- Total bilirubin ≤ 1.5 x ULN for the laboratory
- Aspartate aminotransferase (AST) ≤ 2 x ULN for the laboratory
- Alanine aminotransferase (ALT) ≤ 2 x ULN for the laboratory
- Prothrombin time with INR ≤ ULN for the laboratory
- A woman of childbearing potential (WCBP), defined as a woman who is < 60 years of age and has not had a hysterectomy, must have a documented negative serum pregnancy test 14 days prior to study registration
- Note: If study treatment is not initiated within 7 days after the pregnancy test, the pregnancy test must be repeated.
- A WCBP and a male patient with a partner who is a WCBP must agree to use a medically accepted method for preventing pregnancy for the duration of study treatment and for at least 6 months following completion of study treatment
- Ability to understand and willingness to sign the consent form
Who cannot join
- Previous TSEB therapy with total dose > 20 Gy
- Previous brentuximab treatment
- Any of the following within 4-3 weeks prior to initiating study treatment
- Systemic biologic therapy
- Monoclonal antibody
- Chemotherapy
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- TSEB
- Phototherapy
- Other investigational therapy
- Anticancer topical therapy, including therapeutic doses of steroids, within 2 weeks prior to initiating study treatment
- Note: Topical steroids at doses intended for symptom management are permitted prior to study enrollment and may continue during study treatment.
- Peripheral sensory neuropathy or peripheral motor neuropathy ≥ grade 2 per NCI CTCAE v4.0
- Diabetic neuropathy (any grade)
- Demyelinating form of Charcot-Marie-Tooth Syndrome
- History of progressive multifocal leukoencephalopathy
- Active or clinically significant cardiac disease including any of the following:
- Unstable angina (eg, anginal symptoms at rest) or onset of angina within 3 months prior to initiating study treatment
- Myocardial infarction within 6 months prior to initiating study treatment
- New York Heart Association (NYHA) class III or IV congestive heart failure (Appendix 4)
- Active ≥ grade 3 (per NCI CTCAE v4) viral, bacterial, or fungal infection within 2 weeks prior to initiation of study treatment
- Known human immunodeficiency virus (HIV) infection
- Known or suspected active hepatitis B or C infection
- Known cirrhosis
- Known Gilbert's Syndrome
- Planned ongoing treatment with another drug that may potentially have adverse interactions with brentuximab vedotin; if such a drug has been used, it must be discontinued at least 1 week prior to initiating study treatment (see Section 6.6); examples of potential interactions include:
- Coadministration of strong inhibitors of CYP3A4 (eg, ketoconazole, ritonavir, clarithromycin)
- Coadministration of CYP3A4 inducers (eg, rifampin)
- Concomitant treatment with strong inhibitors of P-glycoprotein (P-gp)
- Known hypersensitivity to any excipient contained in the brentuximab formulation
- Prior malignancy or myelodysplastic syndrome (active within 3 years of screening) except completely excised non-invasive basal cell or squamous cell carcinoma of the skin, and in situ squamous cell carcinoma of the cervix
- Pregnancy or breastfeeding
- Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
About this study
Official title: Phase 1B Trial: Evaluation of the Safety of Adding Brentuximab Vedotin to Low-Dose Total Skin Electron Beam (TSEB) for Treatment of Patients With Mycosis Fungoides and Sézary Syndrome
The purpose of this study is to evaluate the cutaneous toxicity and treatment response associated with administering concurrent TSEB and brentuximab vedotin in patients with mycosis fungoides or Sézary Syndrome.
Read the detailed description
This study is a 2-cohort, open-label, phase 1B trial to evaluate the cutaneous toxicity, overall toxicity, and treatment response associated with administering concurrent low-dose TSEB and brentuximab vedotin in patients with mycosis fungoides or Sézary Syndrome. Duration of complete skin response, DOCB, and tumor response in lymph nodes and blood will also be evaluated. Additionally, skin-related QOL and neurotoxicity will be assessed.
Patients will be enrolled in 1 of 2 cohorts based on disease stage.
Cohort A will include patients with earlier stage disease (selected Stage IB in patients who have had one previous course of therapy) and Stages IIA through IIIA [if N0-1]).
Cohort B will include patients with more advanced disease (Stage IIA through IIIA [if N2-3], Stage IIIB, Stage IVA, and transformed CTCL) who are candidates for low-dose TSEB and/or systemic therapy.
A standard dose of brentuximab vedotin will be administered to all patients by intravenous infusion 3 weeks prior to initiation of low-dose TSEB and then every 3 weeks for a total of 3 cycles. Cohort A patients will complete brentuximab vedotin after 3 cycles; patients in Cohort B will continue brentuximab vedotin until disease progression or unacceptable toxicity, whichever occurs first. In the absence of progression or unacceptable toxicity, the patient may receive brentuximab vedotin for up to 2 years as a study participant. A total of 12 Gy TSEB (ie, low-dose TSEB) will be administered to both cohorts per standard protocol in 6 fractions (2 fractions per week) beginning 3 weeks after the first dose of brentuximab vedotin.
The Modified Severity Weighted Assessment Tool (mSWAT) (16), completed by the investigator, will be used to determine skin involvement at baseline and skin response to treatment beginning after administration of the 3 doses of brentuximab vedotin and low-dose TSEB. Skindex-16, a patient-completed form that measures symptoms and perceptions of toxicity in patients with skin disease will be used to assess skin-related QOL. Additionally, Form NTX will be completed by patients in Cohort A to assess symptoms of CIPN which is a side effect of brentuximab vedotin.
The sample size for this study will be a maximum of 15 patients for a total of 12 evaluable patients with no more than 6 patients in Cohort B. However, if the number of patients with severe toxicity exceeds the established acceptable incidence, accrual will end before reaching the sample size goal of 12 evaluable patients.
- Conditions
- Mycosis Fungoides, Sézary Syndrome
- Being tested
- TSEB Therapy, Brentuximab vedotin
- Keywords
- CD30-positive, Stage IB to Stage IVA
- Medical subject headings
- Mycosis Fungoides, Sezary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TSEB TherapyRadiation
Also called total skin electron beam, TSEB
TSEB is a type of radiation treatment in which the skin over the whole body is treated with electron radiation beams. All participants will receive the same standard TSEB dose and treatment schedule. During TSEB, patients are treated in a standing position on a rotating platform.
Brentuximab vedotinDrug
Also called Adcetris
An antibody-drug conjugate (ADC) that targets CD30. A standard dose of brentuximab vedotin will be administered to all patients by intravenous infusion 3 weeks prior to initiation of TSEB and then every 3 weeks for 3 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A (Stage IB and Stage IIA to IIIB [if N0-1]) | Experimental | (Eligible patients with Stage IB, IIA, IIB, and IIIA [if N0-1])
Brentuximab Vedotin 1.8 mg/kg IV every 3 weeks for 3 doses beginning 3 weeks prior to initiation of TSEB.
TSEB 12 Gy in 6 fractions at 2 Gy/fraction treated twice/week. Receives: Radiation: TSEB Therapy; Drug: Brentuximab vedotin |
| Cohort B(Stage IIA to IIIB; IVA;transformed CTCL) | Experimental | (Eligible patients with Stage IIA, IIB, IIIA [if N2-3]; IIIB; Stage IVA; and transformed CTCL)
Brentuximab Vedotin 1.8 mg/kg IV every 3 weeks for 3 doses beginning 3 weeks prior to initiation of TSEB.
TSEB 12 Gy in 6 fractions at 2 Gy/fraction treated twice/week.
Continuation of brentuximab every 3 weeks until disease progression or unacceptable toxicity or for up to 2 years as a study participant, (whichever occurs first). Receives: Radiation: TSEB Therapy; Drug: Brentuximab vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cutaneous toxicity of combining TSEB and brentuximab vedotin in patients with MF or SS (Cohorts A and B).
Selected cutaneous adverse events (AEs) that occurred during treatment or during the 3 months following initiation of study treatment and that are characterized and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0) including ≥ grade 3 AEs and selected grade 2 AEs
Measured: 6 months
Number of patients who achieved Complete Response (CR) and Partial Response(PR)
Number of patients who have achieved cutaneous CR to treatment defined as 100% clearance of skin lesions or cutaneous partial response (PR) defined as 50%-99% clearance of skin disease from baseline without new tumors in patients with T1-, T2-, or T4-only skin disease.
Measured: 2 years
Secondary outcomes (7)
Duration of complete skin response (Cohorts A and B)
Duration of skin response defined as the time from first determination of CR until relapse in the skin based on mSWAT assessment.
Measured: 2 years
Tumor response in lymph nodes (Cohort B)
Tumor response in lymph nodes for patients with N2 or N3 disease at baseline.
Measured: 6 months
Tumor response in blood (Cohort B)
Tumor response in blood for patients with B1 or B2 disease at baseline.
Measured: 6 months
Overall Toxicity (Cohorts A and B)
AEs reported using criteria in the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) and AEs defined in the protocol.
Measured: 2 years
Skin-related Quality of Life (QOL) (Cohorts A and B)
Patient responses to questions on Skindex-16 (standardized assessment measures for patients with skin disease) that will be administered at baseline and at 2, 4, 10, and 16 weeks following completion of TSEB
Measured: 2 years
Patient-reported chemotherapy-induced peripheral neuropathy (CIPN) (Cohort A)
Patient responses to questions on Form NTX (standardized patient-completed assessment tool to evaluate CIPN) that will be administered at baseline and at 2, 4, 10, and 16 weeks following completion of TSEB.
Measured: 2 years
Duration of clinical benefit (DOCB)
DOCB defined as the time from initial response until any total skin-equivalent treatment (eg, topical treatment to > 50% of body surface, phototherapy, second TSEB treatment) or systemic therapy is initiated, or until disease progression.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study start19 Dec 2016
- Primary completion29 Apr 2019
- Study completion29 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycosis FungoidesStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Seagen Inc.
- Responsible party
- Sponsor
- Investigators
- Shiyu Song, M.D., Ph.D., Principal investigator, Massey Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822586
- Sponsor's protocol ID
- MCC-15-10917
- Other IDs
- IST2015100830, NCI-2016-01509
- Status last verified
- Aug 2019
- First submitted
- 30 Jun 2016
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1B Trial: Evaluation of the Safety of Adding Brentuximab Vedotin to Low-Dose Total Skin Electron Beam (TSEB) for Treatment of Patients With Mycosis Fungoides and Sézary Syndrome
- ClinicalTrials.gov ID
- NCT02822586
- Acronym / sponsor ID
- MCC-15-10917
- Conditions
- Mycosis Fungoides, Sézary Syndrome
- Keywords
- CD30-positive, Stage IB to Stage IVA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Seagen Inc.
- Study start
- 19 Dec 2016 (actual)
- Primary completion
- 29 Apr 2019 (actual)
- Study completion
- 29 Apr 2019 (actual)
- First posted
- 4 Jul 2016 (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 purpose of this study is to evaluate the cutaneous toxicity and treatment response associated with administering concurrent TSEB and brentuximab vedotin in patients with mycosis fungoides or Sézary Syndrome.
Detailed description
This study is a 2-cohort, open-label, phase 1B trial to evaluate the cutaneous toxicity, overall toxicity, and treatment response associated with administering concurrent low-dose TSEB and brentuximab vedotin in patients with mycosis fungoides or Sézary Syndrome. Duration of complete skin response, DOCB, and tumor response in lymph nodes and blood will also be evaluated. Additionally, skin-related QOL and neurotoxicity will be assessed.
Patients will be enrolled in 1 of 2 cohorts based on disease stage.
Cohort A will include patients with earlier stage disease (selected Stage IB in patients who have had one previous course of therapy) and Stages IIA through IIIA [if N0-1]).
Cohort B will include patients with more advanced disease (Stage IIA through IIIA [if N2-3], Stage IIIB, Stage IVA, and transformed CTCL) who are candidates for low-dose TSEB and/or systemic therapy.
A standard dose of brentuximab vedotin will be administered to all patients by intravenous infusion 3 weeks prior to initiation of low-dose TSEB and then every 3 weeks for a total of 3 cycles. Cohort A patients will complete brentuximab vedotin after 3 cycles; patients in Cohort B will continue brentuximab vedotin until disease progression or unacceptable toxicity, whichever occurs first. In the absence of progression or unacceptable toxicity, the patient may receive brentuximab vedotin for up to 2 years as a study participant. A total of 12 Gy TSEB (ie, low-dose TSEB) will be administered to both cohorts per standard protocol in 6 fractions (2 fractions per week) beginning 3 weeks after the first dose of brentuximab vedotin.
The Modified Severity Weighted Assessment Tool (mSWAT) (16), completed by the investigator, will be used to determine skin involvement at baseline and skin response to treatment beginning after administration of the 3 doses of brentuximab vedotin and low-dose TSEB. Skindex-16, a patient-completed form that measures symptoms and perceptions of toxicity in patients with skin disease will be used to assess skin-related QOL. Additionally, Form NTX will be completed by patients in Cohort A to assess symptoms of CIPN which is a side effect of brentuximab vedotin.
The sample size for this study will be a maximum of 15 patients for a total of 12 evaluable patients with no more than 6 patients in Cohort B. However, if the number of patients with severe toxicity exceeds the established acceptable incidence, accrual will end before reaching the sample size goal of 12 evaluable patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A (Stage IB and Stage IIA to IIIB [if N0-1]) | Experimental | Radiation: TSEB Therapy, Drug: Brentuximab vedotin(Eligible patients with Stage IB, IIA, IIB, and IIIA [if N0-1]) Brentuximab Vedotin 1.8 mg/kg IV every 3 weeks for 3 doses beginning 3 weeks prior to initiation of TSEB. TSEB 12 Gy in 6 fractions at 2 Gy/fraction treated twice/week. |
| Cohort B(Stage IIA to IIIB; IVA;transformed CTCL) | Experimental | Radiation: TSEB Therapy, Drug: Brentuximab vedotin(Eligible patients with Stage IIA, IIB, IIIA [if N2-3]; IIIB; Stage IVA; and transformed CTCL) Brentuximab Vedotin 1.8 mg/kg IV every 3 weeks for 3 doses beginning 3 weeks prior to initiation of TSEB. TSEB 12 Gy in 6 fractions at 2 Gy/fraction treated twice/week. Continuation of brentuximab every 3 weeks until disease progression or unacceptable toxicity or for up to 2 years as a study participant, (whichever occurs first). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- Histologically confirmed CD30-positive (defined in this study as ≥ 1% expression) Mycosis Fungoides (including large cell transformation variant) or Sezary Syndrome who have either:
- Any of the disease stages listed below
- Candidate for TSEB based on investigator determination
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2, or 3, if the performance status of 3 is due to skin disease involvement
- Adequate bone marrow function as defined below:
Key exclusion criteria (32 listed)
- Previous TSEB therapy with total dose > 20 Gy
- Previous brentuximab treatment
- Any of the following within 4-3 weeks prior to initiating study treatment
- Anticancer topical therapy, including therapeutic doses of steroids, within 2 weeks prior to initiating study treatment
- Peripheral sensory neuropathy or peripheral motor neuropathy ≥ grade 2 per NCI CTCAE v4.0
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 |
|---|---|---|
| TSEB TherapyAlso: total skin electron beam, TSEBTSEB is a type of radiation treatment in which the skin over the whole body is treated with electron radiation beams. All participants will receive the same standard TSEB dose and treatment schedule. During TSEB, patients are treated in a standing position on a rotating platform. | Radiation | Cohort A (Stage IB and Stage IIA to IIIB [if N0-1]), Cohort B(Stage IIA to IIIB; IVA;transformed CTCL) |
| Brentuximab vedotinAlso: AdcetrisAn antibody-drug conjugate (ADC) that targets CD30. A standard dose of brentuximab vedotin will be administered to all patients by intravenous infusion 3 weeks prior to initiation of TSEB and then every 3 weeks for 3 cycles. | Drug | Cohort A (Stage IB and Stage IIA to IIIB [if N0-1]), Cohort B(Stage IIA to IIIB; IVA;transformed CTCL) |
Primary outcome
Cutaneous toxicity of combining TSEB and brentuximab vedotin in patients with MF or SS (Cohorts A and B).
Time frame: 6 months
Selected cutaneous adverse events (AEs) that occurred during treatment or during the 3 months following initiation of study treatment and that are characterized and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0) including ≥ grade 3 AEs and selected grade 2 AEs
Number of patients who achieved Complete Response (CR) and Partial Response(PR)
Time frame: 2 years
Number of patients who have achieved cutaneous CR to treatment defined as 100% clearance of skin lesions or cutaneous partial response (PR) defined as 50%-99% clearance of skin disease from baseline without new tumors in patients with T1-, T2-, or T4-only skin disease.
7 secondary outcomes
Duration of complete skin response (Cohorts A and B)
Time frame: 2 years
Tumor response in lymph nodes (Cohort B)
Time frame: 6 months
Tumor response in blood (Cohort B)
Time frame: 6 months
Overall Toxicity (Cohorts A and B)
Time frame: 2 years
Skin-related Quality of Life (QOL) (Cohorts A and B)
Time frame: 2 years
Patient-reported chemotherapy-induced peripheral neuropathy (CIPN) (Cohort A)
Time frame: 2 years
Duration of clinical benefit (DOCB)
Time frame: 2 years
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 30 Aug 2019.
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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.
Shiyu Song, M.D., Ph.D. principal investigator
Massey Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TSEB Therapy and Brentuximab vedotin in people with Mycosis Fungoides and Sézary Syndrome, run by Virginia Commonwealth University 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 31 inclusion and 32 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 30 Aug 2019. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Cutaneous toxicity of combining TSEB and brentuximab vedotin in patients with MF or SS (Cohorts A and B). (time frame: 6 months). The study lists 2 primary outcomes in all. 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 30 Aug 2019.