28:I[164923,["/_next/static/immutable/chunks/0x-9rc1bm-510.js","/_next/static/immutable/chunks/0u73ovrok9bmr.js","/_next/static/immutable/chunks/3t9ifrnugpnlb.js","/_next/static/immutable/chunks/3gdp0tzp2t65u.js","/_next/static/immutable/chunks/0qexc5596g7lf.js","/_next/static/immutable/chunks/3nkl8euu6dycn.js","/_next/static/immutable/chunks/28p3k9kvs3dfa.js","/_next/static/immutable/chunks/04j_o97cgxn2x.js","/_next/static/immutable/chunks/18bybpoq919w1.js"],"ClinicalTrialDetail"] 27:T43d,{"@context":"https://schema.org","@type":"MedicalWebPage","name":"Safety and Effectiveness of A-dmDT390-bisFv(UCHT1) Fusion Protein in Subjects With Mycosis Fungoides","description":"This study evaluates the effectiveness - as judged by complete response - of a single four-day treatment with the fusion protein A-dmDT390-bisFv(UCHT1) compared to oral Zolinza (Vorinostat), in a randomized 2-arm trial after a maximum of 12 months of treatment. Patient eligibility is stage IB/IIB mycosis fungoides with mSWAT \\\u003c 50 who have never had lymphoid disease or a prior bone marrow / HSCT transplant.","url":"https://clareohealth.com/clinical-trials/NCT02943642","mainEntity":{"@id":"https://clareohealth.com/clinical-trials/NCT02943642"},"specialty":{"@type":"MedicalSpecialty","name":"Clinical Research"},"audience":{"@type":"PeopleAudience","audienceType":"Patients and Caregivers"},"lastReviewed":"2026-05-18","medicalAudience":{"@type":"MedicalAudience","audienceType":"Patient"},"reviewedBy":{"@type":"Organization","name":"ClinicalTrials.gov","url":"https://clinicaltrials.gov"}}25:["$","script","2",{"type":"application/ld+json","dangerouslySetInnerHTML":{"__html":"$27"}}] 29:T46b,Primary Objective: This study objective is to document the incidence of complete responses compared to oral vorinostat, in a randomized 2-arm trial after a maximum of 12 months of treatment for subjects with stage IB/IIB mycosis fungoides with mSWAT \< 50 who have never had lymphoid disease or a prior bone marrow / HSCT transplant. Secondary Objective: To further explore the toxicity profile of A-dmDT390-bisFv(UCHT1) fusion protein for subjects with mycosis fungoides who have been selected to be free from preexisting cardiac disease and never treated with Campath. Number of Subjects: Lead-in Dosing: 12 / Randomized: 162 Patients will receive full supportive care during the course of the study. Participation in the study will require IV infusions of the research agent 2 times a day for four days (protocol FDA outpatient approved), as well as frequent outpatient blood draws for the first 30 days. Patients with partial or complete remissions at their 1 month follow up visit will have another follow-up visit on day 60, then every three months for 1 year, followed by annual visits to assess duration of the response.2a:Tf45,Inclusion Criteria: * Subjects must have signed the current IRB approved informed consent prior to registration (see Informed Consent). * Mycosis fungoides, confirmed by biopsy or flow cytometry, without large cell transformation. * Relapse or progression after 2 or more systemic therapies. Note: Total electron beam therapy can be counted as a systemic therapy. * Disease stage as follows: * Stage IB with no lymph node involvement including lymphadenopathy with mSWAT \<50; * Stage IIB with no lymph node involvement including lymphadenopathy with mSWAT \<50. * Age 18 years. * Subjects must have a performance status of \< 2 on Eastern Cooperative Oncology Group scale (see Appendix A). * Subjects must have normal lung function evaluated by pulse oximetry with O2 saturation values between 95-100%. * Subjects must have fully recovered from toxicity of prior chemotherapy or radiation therapy. * Subjects must have: * bilirubin \< 1.5 mg/dL, * transaminases \< 2.5 X ULN, * albumin \> 3 gm/dL, * creatinine \< 2.0 mg/dL. * Subjects who have had albumin \< 3 gm/dL boosted by an albumin infusion must be observed to maintain albumin at \> 3gm dL for 14 days without an additional infusion. * Subjects must have a normal echocardiogram (EF \> 50% normal) without any evidence of cardiac chamber hypertrophy, dilatation or hypokinesis. * Females and males must be willing to use an approved form of birth control while on this study and for 2 weeks after completion. * Subjects must have a pretreatment anti-DT titer of 20 μg/ml or less. Subjects with titers between 21 and 35 μg/ml will have an additional anti-DT neutralization test using subject's serum and A-dmDT390-bisFv(UCHT1). If neutralization is not found these titers will be considered acceptable. Exclusion Criteria: * Failure to meet any of the criteria. * Inability to give informed consent because of psychiatric problems, or complicated medical problems. * Allergic to diphtheria toxin a component of the study drug A-dmDT390-bisFv(UCHT1). * Serious concurrent medical problems, uncontrolled infections, or disseminated intravascular coagulopathy (DIC), hepatic cirrhosis, or chronic kidney disease. * CNS leukemia. * Preexisting cardiovascular disease. The only exception being well controlled essential hypertension with a sitting blood pressure (B.P.) of \<160 systolic and \<90 diastolic without any evidence of structural heart disease or one episode of myocardial infarction \> 8 months ago. Subjects receiving a beta-blocker for hypertension should be converted to another antihypertensive drug class 2-3 weeks before receiving the study drug to prevent a drug-drug interaction reactive tachycardia. Angiotensin inhibitors, angiotensin receptor blockers and calcium channel blockers are all acceptable. A past history of any of the following conditions is considered as exclusions to study participation: * Congestive heart failure, * Atrial fibrillation, * Pulmonary hypertension, * Anticoagulant drug therapy, * Thromboembolic events, * Cardiomyopathy or a myocardial infarction within the past 8 months. The PI and the Clinical Coordinator will be asked to verify that their referred subjects do not have these exclusionary histories listed in 3.2 and a copy of this verification must be sent to the Sponsor before the Sponsor will approve of enrollment. Referring physicians will not need to sign. * Pregnant or nursing women will be excluded from study. * History of cirrhosis of the liver based on the Child-Pugh score of Class B or C are not eligible to participate. * Prior treatment with alemtuzumab (Campath) or similar agents or procedures that depress blood T cell counts to below 50% of the lower limit of normal. * Prior history of bone marrow transplant or HSCT is an exclusion. * Prior treatment with vorinostat (Prior treatment with vorinostat for lead-in dosing arm is acceptable).26:["$","$L28",null,{"trial":{"nctId":"NCT02943642","briefTitle":"Safety and Effectiveness of A-dmDT390-bisFv(UCHT1) Fusion Protein in Subjects With Mycosis Fungoides","officialTitle":"Safety and Effectiveness of A-dmDT390-bisFv(UCHT1) Fusion Protein (Resimmune®) in Subjects With Mycosis Fungoides: A Phase II Multi-center Randomized Clinical Trial","briefSummary":"This study evaluates the effectiveness - as judged by complete response - of a single four-day treatment with the fusion protein A-dmDT390-bisFv(UCHT1) compared to oral Zolinza (Vorinostat), in a randomized 2-arm trial after a maximum of 12 months of treatment. Patient eligibility is stage IB/IIB mycosis fungoides with mSWAT \\< 50 who have never had lymphoid disease or a prior bone marrow / HSCT transplant.","detailedDescription":"$29","overallStatus":"WITHDRAWN","phase":"PHASE2","studyType":"INTERVENTIONAL","conditions":["Mycosis Fungoides"],"interventions":[{"type":"BIOLOGICAL","name":"A-dmDT390-bisFv(UCHT1)","description":"anti-T cell immunotoxin (antibody targeting CD3 on T-cells tagged with diphtheria toxin without binding domain)"},{"type":"DRUG","name":"Vorinostat","description":"ZOLINZA is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies."}],"keywords":["MF","CTCL","Cutaneous T Cell Lymphoma"],"locations":null,"eligibilityCriteria":"$2a","minAge":18,"maxAge":null,"sex":"ALL","healthyVolunteers":false,"leadSponsor":"Virogen Biotechnology Inc.","collaborators":["City of Hope National Medical Center","Columbia University","Dana-Farber Cancer Institute","Northwestern University","H. Lee Moffitt Cancer Center and Research Institute","Ohio State University Comprehensive Cancer Center","Rush University Medical Center","Scott and White Hospital & Clinic","Yale University","Stanford University","Thomas Jefferson University","University of Arkansas","University of Colorado, Denver","University of Texas Southwestern Medical Center","University of Washington","Vanderbilt University School of Medicine","Washington University School of Medicine"],"contacts":null,"startDate":"$D2026-05-01T00:00:00.000Z","completionDate":"$D2026-05-13T00:00:00.000Z","primaryCompletionDate":"$D2026-05-13T00:00:00.000Z","firstPostDate":"$D2016-10-25T00:00:00.000Z","lastUpdatePostDate":"$D2026-05-18T00:00:00.000Z","enrollmentCount":0,"enrollmentType":"ACTUAL","aiSummary":"$undefined","aiSummaryGeneratedAt":null,"id":"$undefined","createdAt":"$undefined","updatedAt":"$undefined"}}]

What this study is about