Patients are searching for this trial right now

This page is already ranking on Google. Activate it to start receiving pre-qualified patient leads directly in your inbox.

14-day free trial · $44/mo after · Cancel anytime · Money-back guarantee

NCT03017820 · Mayo Clinic

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

What this study is about

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).

View original scientific description

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.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion criteria

  • Age \>= 18 years
  • Relapsed or refractory disease as follows:
  • Groups A, B, C or D: Multiple myeloma (MM) previously treated with an immunomodulatory imide drug (IMID), a proteosome inhibitor, and an alkylating agent
  • 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
  • Group B and C only: B-cell lymphoma (other than Burkitt's lymphoma), or histiocytic/dendritic cell neoplasms (HCN) at any stage
  • 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)
  • Group F only: Expansion Cohort for B-cell lymphoma (other than Burkitt's lymphoma) with low tumor burden
  • Group G only: Expansion Cohort for peripheral T cell lymphoma (PTCL) with low tumor burden
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 2 times upper limit of normal (ULN) (obtained =\< 15 days prior to registration)
  • Creatinine =\< 2.0 mg/dL (obtained =\< 15 days prior to registration)
  • Direct bilirubin =\< 1.5 x ULN (obtained =\< 15 days prior to registration)
  • International normalized ratio (INR)/prothrombin time (PT) and activated partial thromboplastin time (aPTT) =\< 1.5 x ULN (obtained =\< 15 days prior to registration)
  • If baseline liver disease, Child Pugh score not exceeding class A (obtained =\< 15 days prior to registration)
  • Negative pregnancy test for persons of child-bearing potential (obtained =\< 15 days prior to registration)
  • FOR MULTIPLE MYELOMA ONLY: Measurable disease of multiple myeloma as defined by at least ONE of the following:
  • Serum monoclonal protein \>= 1.0 g/dL by protein electrophoresis
  • \>= 200 mg of monoclonal protein in the urine on 24-hour electrophoresis
  • Serum immunoglobulin free light chain \>= 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
  • FOR MULTIPLE MYELOMA ONLY: Absolute neutrophil count (ANC) \>= 1000/uL (obtained =\< 14 days prior to registration)
  • FOR MULTIPLE MYELOMA ONLY: Platelet (PLT) \>= 100,000/uL (obtained =\< 14 days prior to registration)
  • FOR MULTIPLE MYELOMA ONLY: Hemoglobin \>= 8.5 g/dl (obtained =\< 14 days prior to registration)
  • FOR AML ONLY: No ANC restriction (obtained =\< 14 days prior to registration)
  • FOR AML ONLY: PLT \>= 10,000/uL (transfusion to get platelets \>= 10,000 is allowed) (obtained =\< 14 days prior to registration)
  • FOR AML ONLY: Hemoglobin \>= 7.5 g/dl (obtained =\< 14 days prior to registration)
  • FOR AML ONLY: Absence of uncompensated disseminated intravascular coagulation (DIC- as diagnosed by standard International Society on Thrombosis and Hemostasis \[ISTH\] criteria)
  • FOR TCL/BCL ONLY: ANC \>= 1,000/uL (obtained =\< 14 days prior to registration)
  • FOR TCL/BCL ONLY: PLT \>= 100,000/uL (obtained =\< 14 days prior to registration)
  • FOR TCL/BCL ONLY: Hemoglobin \>= 8.5 g/dl (obtained =\< 14 days prior to registration)
  • FOR TCL/BCL 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/L; 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
  • FOR HCN ONLY: ANC \>= 1,000/uL obtained =\< 15 days prior to registration
  • FOR HCN ONLY: PLT \>= 100,000/uL obtained =\< 15 days prior to registration
  • FOR HCN ONLY: Hemoglobin \>= 8.0 g/dl obtained =\< 15 days prior to registration
  • 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/L. 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
  • Absence of active central nervous system (CNS) involvement; NOTE: pre-enrollment lumbar puncture not mandatory
  • Ability to provide written informed consent
  • Willingness to return to Mayo Clinic for follow-up
  • Life expectancy \>= 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
  • Willing to provide mandatory biological specimens for research purposes

Exclusion criteria

  • Availability of and patient acceptance of curative therapy
  • Uncontrolled infection
  • Active tuberculosis or hepatitis, or chronic hepatitis
  • Any of the following prior therapies:
  • Chemotherapy (IMIDs, alkylating agents, proteosome inhibitors) =\< 2 weeks prior to registration
  • Immunotherapy (monoclonal antibodies) =\< 4 weeks prior to registration
  • Experimental agent in case of AML or TCL within 4 half-lives of the last dose of the agent
  • 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 \[SVT\])
  • 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)
  • Human immunodeficiency virus (HIV) positive test result or other immunodeficiency or immunosuppression
  • 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);
  • NOTE: in AML, the concurrent use of hydroxyurea to help control proliferative counts is allowed throughout the treatment protocol;
  • 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)
  • 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:
  • Pregnant women or women of reproductive ability who are unwilling to use effective contraception
  • Nursing women
  • 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
  • AML ONLY: Current disseminated intravascular coagulopathy (DIC)
  • ADDITIONAL EXCLUSION CRITERIA FOR GROUP A (LOW TUMOR BURDEN) ONLY:
  • Diagnosis of AML
  • Multiple myeloma only: \> 25% plasma cells or plasmacytoma \> 5cm in largest diameter
  • Lymphoma or HCN only: Any mass \>5cm
  • Diagnosis of Burkitt's lymphoma
  • ADDITIONAL EXCLUSION CRITERIA FOR GROUP B (HIGH TUMOR BURDEN) ONLY:
  • Diagnosis of AML
  • Diagnosis of Burkitt's lymphoma
  • ADDITIONAL EXCLUSION CRITERIA FOR GROUP C (COMBINATION WITH CYCLOPHOSPHAMIDE) ONLY:
  • Diagnosis of AML
  • Diagnosis of Burkitt's lymphoma
  • ADDITIONAL EXCLUSION CRITERIA FOR GROUP E (COMBINATION WITH CEMIPLIMAB) ONLY:
  • Diagnosis of AML
  • Diagnosis of AITL
  • ADDITIONAL EXCLUSION CRITERIA FOR GROUP F (BCL EXPANSION COHORT) ONLY:
  • Diagnosis of Burkitt's lymphoma
  • ADDITIONAL EXCLUSION CRITERIA FOR GROUP G (PTCL EXPANSION COHORT) ONLY:
  • Diagnosis of cutaneous TCL

Where

  • Scottsdale, Arizona
  • Rochester, Minnesota

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Jun 10, 2026 · Source of record for eligibility and locations

📊
1 of 99 participants interested
1% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

Preparing your pre-screening questions…

Study locations

Choose your preferred location, or select flexible during enrollment.

RECRUITING

Scottsdale

Arizona

Location available
RECRUITING

Rochester

Minnesota

Location available

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

Find More Lymphoma Trials by City

Browse all lymphoma clinical trials in these cities — not just this study.

Looking for B-Cell Non-Hodgkin Lymphoma Treatment in Scottsdale?

Join others in Arizona exploring innovative treatment options through clinical research

B-Cell Non-Hodgkin Lymphoma Treatment Options in Scottsdale, Arizona

If you're searching for B-Cell Non-Hodgkin Lymphoma treatment in Scottsdale, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Scottsdale, Rochester and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with B-Cell Non-Hodgkin Lymphoma. All study-related care is provided at no cost to participants.

Local Sites
2 locations in Arizona
Now Enrolling
Up to 99 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for B-Cell Non-Hodgkin Lymphoma?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for B-Cell Non-Hodgkin Lymphoma

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This B-Cell Non-Hodgkin Lymphoma Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT03017820. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.