[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractory-t-cell-non-hodgkin-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractory-t-cell-non-hodgkin-lymphoma":44},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,57],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":5},"100287143","phase-1-a-vaccine-vsv-hifn-nis-with-or-without-cyclophosphamide-and-combinations-of-ipilimumab-nivolumab-and-cemiplimab-in-treating-relapsed-or-refractory-multiple-myeloma-acute-myeloid-leukemia-or-lymphoma-100287143",false,"NCT03017820","A Vaccine (VSV-hIFNβ-NIS) With or Without Cyclophosphamide and Combinations of Ipilimumab, Nivolumab, and Cemiplimab in Treating Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia or Lymphoma","MC1684 Phase I Trial of Systemic Administration of Vesicular Stomatitis Virus Genetically Engineered to Express NIS and Human Interferon, in Patients With Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia, Lymphomas, or Histiocytic\u002FDendritic Cell Neoplasms","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Relapsed or refractory disease as follows:\n\n  * Groups A, B, C or D: Multiple myeloma (MM) previously treated with an immunomodulatory imide drug (IMID), a proteosome inhibitor, and an alkylating agent\n  * All Groups except D: Relapsed peripheral T-cell lymphoma (PTCL) of the following histologies: peripheral T-cell lymphoma-NOS (PTCL-NOS); angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell (ALCL), and mycosis fungoides (MF). Patients should have failed standard therapy and in the case of PTCL-NOS, AITL, and ALCL either have failed or be ineligible for high-dose therapy with autologous stem cell transplant\n  * Group B and C only: B-cell lymphoma (other than Burkitt's lymphoma), or histiocytic\u002Fdendritic cell neoplasms (HCN) at any stage\n  * Group E only: Relapsed peripheral T-cell lymphoma (PTCL) of the following histologies: peripheral T-cell lymphoma-NOS (PTCL-NOS); anaplastic large cell (ALCL), and mycosis fungoides (MF)\n  * Group F only: Expansion Cohort for B-cell lymphoma (other than Burkitt's lymphoma) with low tumor burden\n  * Group G only: Expansion Cohort for peripheral T cell lymphoma (PTCL) with low tumor burden\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\\\u003C 2 times upper limit of normal (ULN) (obtained =\\\u003C 15 days prior to registration)\n* Creatinine =\\\u003C 2.0 mg\u002FdL (obtained =\\\u003C 15 days prior to registration)\n* Direct bilirubin =\\\u003C 1.5 x ULN (obtained =\\\u003C 15 days prior to registration)\n* International normalized ratio (INR)\u002Fprothrombin time (PT) and activated partial thromboplastin time (aPTT) =\\\u003C 1.5 x ULN (obtained =\\\u003C 15 days prior to registration)\n* If baseline liver disease, Child Pugh score not exceeding class A (obtained =\\\u003C 15 days prior to registration)\n* Negative pregnancy test for persons of child-bearing potential (obtained =\\\u003C 15 days prior to registration)\n* FOR MULTIPLE MYELOMA ONLY: Measurable disease of multiple myeloma as defined by at least ONE of the following:\n\n  * Serum monoclonal protein \\>= 1.0 g\u002FdL by protein electrophoresis\n  * \\>= 200 mg of monoclonal protein in the urine on 24-hour electrophoresis\n  * Serum immunoglobulin free light chain \\>= 10 mg\u002FdL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio\n* FOR MULTIPLE MYELOMA ONLY: Absolute neutrophil count (ANC) \\>= 1000\u002FuL (obtained =\\\u003C 14 days prior to registration)\n* FOR MULTIPLE MYELOMA ONLY: Platelet (PLT) \\>= 100,000\u002FuL (obtained =\\\u003C 14 days prior to registration)\n* FOR MULTIPLE MYELOMA ONLY: Hemoglobin \\>= 8.5 g\u002Fdl (obtained =\\\u003C 14 days prior to registration)\n* FOR AML ONLY: No ANC restriction (obtained =\\\u003C 14 days prior to registration)\n* FOR AML ONLY: PLT \\>= 10,000\u002FuL (transfusion to get platelets \\>= 10,000 is allowed) (obtained =\\\u003C 14 days prior to registration)\n* FOR AML ONLY: Hemoglobin \\>= 7.5 g\u002Fdl (obtained =\\\u003C 14 days prior to registration)\n* FOR AML ONLY: Absence of uncompensated disseminated intravascular coagulation (DIC- as diagnosed by standard International Society on Thrombosis and Hemostasis \\[ISTH\\] criteria)\n* FOR TCL\u002FBCL ONLY: ANC \\>= 1,000\u002FuL (obtained =\\\u003C 14 days prior to registration)\n* FOR TCL\u002FBCL ONLY: PLT \\>= 100,000\u002FuL (obtained =\\\u003C 14 days prior to registration)\n* FOR TCL\u002FBCL ONLY: Hemoglobin \\>= 8.5 g\u002Fdl (obtained =\\\u003C 14 days prior to registration)\n* FOR TCL\u002FBCL ONLY: Measurable disease by CT or magnetic resonance imaging (MRI): must have at least one lesion that has a single diameter of \\> 2 cm or tumor cells in the blood \\> 5 x 10\\^9\u002FL; NOTE: skin lesions can be used if the area is \\> 2 cm in at least one diameter and photographed with a ruler and the images are available in the medical record\n* FOR HCN ONLY: ANC \\>= 1,000\u002FuL obtained =\\\u003C 15 days prior to registration\n* FOR HCN ONLY: PLT \\>= 100,000\u002FuL obtained =\\\u003C 15 days prior to registration\n* FOR HCN ONLY: Hemoglobin \\>= 8.0 g\u002Fdl obtained =\\\u003C 15 days prior to registration\n* FOR HCN ONLY: Measurable disease by CT or MRI: Must have at least one lesion that has a single diameter of \\>= 1.5 cm or tumor cells in the blood \\>5 x10\\^9\u002FL. NOTE: Skin lesions can be used if the area is \\>= 1.5 cm in at least one diameter and photographed with a ruler and the images are available in the medical record\n* Absence of active central nervous system (CNS) involvement; NOTE: pre-enrollment lumbar puncture not mandatory\n* Ability to provide written informed consent\n* Willingness to return to Mayo Clinic for follow-up\n* Life expectancy \\>= 12 weeks\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2\n* Willing to provide mandatory biological specimens for research purposes\n\nExclusion Criteria:\n\n* Availability of and patient acceptance of curative therapy\n* Uncontrolled infection\n* Active tuberculosis or hepatitis, or chronic hepatitis\n* Any of the following prior therapies:\n\n  * Chemotherapy (IMIDs, alkylating agents, proteosome inhibitors) =\\\u003C 2 weeks prior to registration\n  * Immunotherapy (monoclonal antibodies) =\\\u003C 4 weeks prior to registration\n  * Experimental agent in case of AML or TCL within 4 half-lives of the last dose of the agent\n* New York Heart Association classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review, or known cardiac arrhythmias (atrial fibrillation or supraventricular tachycardia \\[SVT\\])\n* Active CNS disorder or seizure disorder or known CNS disease or neurologic symptomatology; in case of AML active CNS involvement as detected by lumbar puncture or neuro-imaging (only to be done if clinically indicated)\n* Human immunodeficiency virus (HIV) positive test result or other immunodeficiency or immunosuppression\n* Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (used for a non-Food and Drug Administration \\[FDA\\] approved indication and in the context of a research investigation);\n\n  * NOTE: in AML, the concurrent use of hydroxyurea to help control proliferative counts is allowed throughout the treatment protocol;\n  * NOTE: in TCL, patients may use topical emollients or corticosteroids, acetic acid soaks, etc. to control pruritus and prevent infection; no topical chemotherapy is allowed (no topical nitrogen mustard)\n* Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:\n\n  * Pregnant women or women of reproductive ability who are unwilling to use effective contraception\n  * Nursing women\n  * Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 4 weeks after stopping treatment\n* AML ONLY: Current disseminated intravascular coagulopathy (DIC)\n* ADDITIONAL EXCLUSION CRITERIA FOR GROUP A (LOW TUMOR BURDEN) ONLY:\n\n  * Diagnosis of AML\n  * Multiple myeloma only: \\> 25% plasma cells or plasmacytoma \\> 5cm in largest diameter\n  * Lymphoma or HCN only: Any mass \\>5cm\n  * Diagnosis of Burkitt's lymphoma\n* ADDITIONAL EXCLUSION CRITERIA FOR GROUP B (HIGH TUMOR BURDEN) ONLY:\n\n  * Diagnosis of AML\n  * Diagnosis of Burkitt's lymphoma\n* ADDITIONAL EXCLUSION CRITERIA FOR GROUP C (COMBINATION WITH CYCLOPHOSPHAMIDE) ONLY:\n\n  * Diagnosis of AML\n  * Diagnosis of Burkitt's lymphoma\n* ADDITIONAL EXCLUSION CRITERIA FOR GROUP E (COMBINATION WITH CEMIPLIMAB) ONLY:\n\n  * Diagnosis of AML\n  * Diagnosis of AITL\n* ADDITIONAL EXCLUSION CRITERIA FOR GROUP F (BCL EXPANSION COHORT) ONLY:\n\n  * Diagnosis of Burkitt's lymphoma\n* ADDITIONAL EXCLUSION CRITERIA FOR GROUP G (PTCL EXPANSION COHORT) ONLY:\n\n  * Diagnosis of cutaneous TCL","ALL","18 Years",{"count":19,"type":20},99,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This phase I trial studies the best dose and side effects of the VSV-hIFNβ-NIS vaccine with or without cyclophosphamide and combinations of ipilimumab, nivolumab, and cemiplimab in treating patients with multiple myeloma, acute myeloid leukemia or lymphoma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). VSV-IFNβ-NIS is a modified version of the vesicular stomatitis virus (also called VSV). This virus can cause infection and when it does it typically infects pigs, cattle, or horses but not humans. The VSV used in this study has been altered by having two extra genes (pieces of DNA) added. The first gene makes a protein called NIS that is inserted into the VSV. NIS is normally found in the thyroid gland (a small gland in the neck) and helps the body concentrate iodine. Having this additional gene will make it possible to track where the virus goes in the body (which organs). The second addition is a gene for human interferon beta (β) or hIFNβ. Interferon is a natural anti-viral protein, intended to protect normal healthy cells from becoming infected with the virus. VSV is very sensitive to the effect of interferon. Many tumor cells have lost the capacity to either produce or respond to interferon. Thus, interferon production by tumor cells infected with VSV-IFNβ-NIS will protect normal cells but not the tumor cells. The VSV with these two extra pieces is referred to as VSV-IFNβ-NIS. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Immunotherapy with monoclonal antibodies, such as ipilimumab, nivolumab, and cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving VSV-IFNβ-NIS with or without cyclophosphamide and combinations of ipilimumab, nivolumab, and cemiplimab may be safe and effective in treating patients with recurrent peripheral T-cell lymphoma.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44],"B-Cell Non-Hodgkin Lymphoma","Histiocytic and Dendritic Cell Neoplasm","Myelodysplastic Syndrome","Previously Treated Myelodysplastic Syndrome","Recurrent Adult Acute Myeloid Leukemia","Recurrent Anaplastic Large Cell Lymphoma","Recurrent Angioimmunoblastic T-Cell Lymphoma","Recurrent Mycosis Fungoides","Recurrent Plasma Cell Myeloma","Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma","Recurrent T-Cell Non-Hodgkin Lymphoma","Refractory Acute Myeloid Leukemia","Refractory Anaplastic Large Cell Lymphoma","Refractory Angioimmunoblastic T-Cell Lymphoma","Refractory Mycosis Fungoides","Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified","Refractory Plasma Cell Myeloma","Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma","Refractory T-Cell Non-Hodgkin Lymphoma","RECRUITING","2026-06-08",{"date":48,"type":49},"2026-06-10","ACTUAL",{"date":51,"type":49},"2017-04-04",{"date":53,"type":20},"2032-04-01",{"name":55,"class":56},"Mayo Clinic","OTHER",{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":21,"phases":66,"briefSummary":68,"conditions":69,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100610315","phase-1-pralatrexate-with-bendamustine-and-total-body-irradiation-followed-by-donor-stem-cell-transplant-for-the-treatment-of-relapsed-or-refractory-t-cell-non-hodgkin-lymphoma-100610315","NCT07225985","Pralatrexate With Bendamustine and Total-Body Irradiation Followed by Donor Stem Cell Transplant for the Treatment of Relapsed or Refractory T-Cell Non-Hodgkin Lymphoma","Pralatrexate and Bendamustine With 3 Gy TBI as a New Reduced Intensity Conditioning (RIC) Regimen for Allogeneic HCT for T-Cell Lymphoma Patients Who Are in Untreated R\u002FR, or in Remission With MRD","Inclusion Criteria:\n\n* Age ≥ 18 years with an HCT-Comorbidity Index (CI) ≤ 5 for patients over 60 years\n* T-cell non-Hodgkin lymphoma (T-NHL) (2022 World Health Organization \\[WHO\\] criteria) including primary cutaneous T-NHL that is in untreated or unsuccessfully treated first or subsequent relapse. Patients in morphologic remission (i.e. \\\u003C 5% blasts in the bone marrow, if involved) but evidence of minimal residual disease (MRD) by positron emission tomography-computed tomography (PET-CT), multiparameter flow cytometry, cytogenetics\u002Ffluorescence in situ hybridization (FISH), or molecular means will be eligible for trial participation\n* The use of bridging chemotherapy prior to initiation of study treatment is allowed. Patients with symptoms\u002Fsigns of hyperleukocytosis, white blood cells (WBC) \\> 100,000\u002FµL, or with concern for other complications of high tumor burden of high tumor dynamics (e.g. disseminated intravascular coagulation) can be treated with leukapheresis or may receive a cycle of salvage chemotherapy prior to start of study treatment\n* Karnofsky score ≥ 70; Eastern Cooperative Oncology Group (ECOG) 0-1\n* Adequate cardiac function defined as absence of decompensated congestive heart failure and\u002For uncontrolled arrhythmia and left ventricular ejection fraction ≥ 45%\n* Bilirubin ≤ 2.5 x institutional upper limit of normal unless elevation is thought to be due to hepatic infiltration by lymphoma, Gilbert's syndrome, or hemolysis\n* Adequate pulmonary function defined as absence of oxygen (O2) requirements and either diffusion capacity of the lung for carbon monoxide (DLCO) corrected ≥ 70%mmHg or DLCO corrected 60-69%mmHg and partial pressure of oxygen (pO2) ≥ 70mmHg\n* Creatinine clearance ≥ 60 mL\u002Fmin\n* Prior autologous HCT is permissible if relapse occurred \\> 6 months after HCT\n* An human leukocyte antigen (HLA)-matched sibling\u002Funrelated donor, mismatched unrelated donor or haploidentical donor for collection of stimulated peripheral blood stem cells must be identified and readily available\n* If the patient has received pralatrexate or bendamustine before and has been sensitive to this regimen, defined as MRD negative complete response (CR) immediately after receiving the treatment and which lasts ≥ 1 year, eligibility will be determined on a case-by-case basis by the study principal investigator (PI)\n* Ability to understand and sign a written informed consent document (or legal representative)\n* RELATED DONOR: Related to the patient and genotypically or phenotypically identical for HLA-A, B, C, DRB1 and DQB1. Phenotypic identity must be confirmed by high-resolution typing\n* MATCHED UNRELATED DONOR: Matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing; OR\n* MATCHED UNRELATED DONOR: Mismatched for a single allele without antigen mismatching at HLA-A, B, or C as defined by high resolution typing but otherwise matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing\n* MATCHED UNRELATED DONOR: Donors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment. The recommended procedure for patients with 10 of 10 HLA allele level (phenotypic) match is to obtain panel reactive antibody (PRA) screens to class I and class II antigens for all patients before HCT. If the PRA shows \\> 10% activity, then flow cytometric or B and T cell cytotoxic cross matches should be obtained. The donor should be excluded if any of the cytotoxic cross match assays are positive. For those patients with an HLA Class I allele mismatch, flow cytometric or B and T cell cytotoxic cross matches should be obtained regardless of the PRA results. A positive anti-donor cytotoxic crossmatch is an absolute donor exclusion.\n* MATCHED UNRELATED DONOR: Patient and donor pairs homozygous at a mismatched allele in the graft rejection vector are considered a two-allele mismatch, i.e., the patient is A\\*0101 and the donor is A\\*0102, and this type of mismatch is not allowed.\n* MISMATCHED UNRELATED DONOR: HLA-matching must be based on results of high resolution typing at HLA-A, -B, -C, -DRB1, and -DQ\n* MISMATCHED UNRELATED DONOR: Mismatch for one HLA class I antigen with or without an additional mismatch for one HLA-class I allele but matched for HLA-DRB1 and HLA-DQ\n* MISMATCHED UNRELATED DONOR: Mismatched for two HLA class I alleles but matched for HLA-DRB1 and HLA-DQ\n* MISMATCHED UNRELATED DONOR: HLA class I HLA-A, -B, -C allele matched donors allowing for any one or two DRB1 and\u002For DQB1 antigen\u002Fallele mismatch\n* MISMATCHED UNRELATED DONOR: If the patient is homozygous at the mismatch HLA class I locus or II locus, the donor must be heterozygous at that locus and one allele must match the patient (i.e., patient is homozygous A\\*01:01 and donor is heterozygous A\\*01:01, A\\*02:01). This mismatch will be considered a one-antigen mismatch for rejection only\n* HAPLOIDENTICAL DONOR: Donors must be haploidentical relatives of the patients. Donor-recipient compatibility will be tested through HLA typing at high resolution for the HLA loci (-A, -B, -C, -DRB1, -DQB1). Donor and recipient should share at least 5\u002F10 HLA loci\n* HAPLOIDENTICAL DONOR: Age ≥ 18 years\n* HAPLOIDENTICAL DONOR: Weight ≥ 40 kg\n* HAPLOIDENTICAL DONOR: Donor must meet the selection criteria as defined by the Foundation of the Accreditation of Cell Therapy (FACT) and will be screened per the American Association of Blood Banks (AABB) guidelines\n* HAPLOIDENTICAL DONOR: In case of more available haploidentical donors, selection criteria should include, in this order:\n\n  * For cytomegalovirus (CMV) seronegative recipients, a CMV seronegative donor\n  * Red blood cell compatibility\n\n    * Red blood cell (RBC) cross match compatible\n    * Minor ABO incompatibility\n    * Major ABO incompatibility\n\nExclusion Criteria:\n\n* Active central nervous system (CNS) disease\n* Concomitant illness associated with a likely survival of \\\u003C 1 year\n* Active systemic fungal, bacterial, viral, or other infection, unless disease is under treatment with antimicrobials and\u002For controlled or stable. Patients with fever thought to be likely secondary to lymphoid malignancy are eligible\n* Known hypersensitivity or contraindication to any study drug used in this trial\n* Pregnancy or lactation\n* Concurrent treatment with any other approved or investigational anti-lymphoma agent at the time of starting conditioning\n* HAPLOIDENTICAL DONOR: Since detection of anti-donor-specific antibodies (anti-DSA) is associated with higher graft rejection rate, patients will be screened for anti-DSA pre-transplant. Patient with DSA mean fluorescent intensity (MFI) \\\u003C 5000 after desensitization treatment, will be considered eligible to participate in the study",{"count":65,"type":20},50,[23,67],"PHASE2","This phase I\u002FII trial studies the side effects and best dose of pralatrexate in combination with bendamustine and total-body irradiation (TBI) followed by a donor stem cell transplant in treating patients with T-cell non-Hodgkin lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Pralatrexate may block the growth of cancer cells and cause them to die. It is a type of dihydrofolate reductase (DHFR) inhibitor. Bendamustine may damage the DNA in cancer cells and cause them to die. It is a type of alkylating agent and a type of antimetabolite. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. TBI is a type of radiation therapy that is given to the entire body. Giving pralatrexate with bendamustine and TBI before a donor stem cell transplant may help kill cancer cells in the body and help make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow.",[36,44],"2026-05-07",{"date":72,"type":49},"2026-05-11",{"date":74,"type":49},"2026-04-27",{"date":76,"type":20},"2030-11-15",{"name":78,"class":56},"Fred Hutchinson Cancer Center",1]