Single Photon Emission Computed Tomography for refractory, primary Cutaneous T-Cell Non-Hodgkin Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mayo Clinic in Arizona, Scottsdale, AZ
refractory, primary Cutaneous T-Cell Non-Hodgkin Lymphoma+34 More
Single Photon Emission Computed Tomography - Procedure
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a virus which has been changed in a certain way, may be able to kill cancer cells without damaging normal cells.

See full description

Eligible Conditions

  • refractory, primary Cutaneous T-Cell Non-Hodgkin Lymphoma
  • refractory, advanced Mycosis fungoides
  • Recurrent Angioimmunoblastic T-Cell Lymphoma
  • Refractory Angioimmunoblastic T-Cell Lymphoma
  • Recurrent T-Cell Non-Hodgkin Lymphoma
  • Myelodysplastic Syndromes (MDS)
  • Recurrent Mycosis Fungoides
  • Myelodysplastic Syndromes, Previously Treated
  • Recurrent Anaplastic Large Cell Lymphoma
  • Refractory Plasma Cell Myeloma
  • Recurrent Plasma Cell Myeloma
  • Refractory Anaplastic Large Cell Lymphoma
  • Recurrent Acute Myeloid Leukemia, Adult
  • Refractory T-Cell Non-Hodgkin Lymphoma
  • Refractory Acute Myelogenous Leukemia (AML)
  • Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
  • Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for refractory, primary Cutaneous T-Cell Non-Hodgkin Lymphoma

Study Objectives

This trial is evaluating whether Single Photon Emission Computed Tomography will improve 1 primary outcome, 3 secondary outcomes, and 2 other outcomes in patients with refractory, primary Cutaneous T-Cell Non-Hodgkin Lymphoma. Measurement will happen over the course of From registration to disease progression or death due to any cause, assessed up to 2 years.

Year 2
Overall survival
Year 2
Progression-free survival
Up to 2 years
Biodistribution and kinetics of virus spread
Clinical response
Incidence of adverse events of grade 3 or higher
NIS gene expression in tumor samples

Trial Safety

Safety Progress

1 of 3

Other trials for refractory, primary Cutaneous T-Cell Non-Hodgkin Lymphoma

Trial Design

3 Treatment Groups

Group B (VSV-IFNbeta-NIS, ruxolitinib)
1 of 3
Group A (VSV-IFNbeta-NIS)
1 of 3
Group C (VSV-IFNbeta-NIS, ruxolitinib, cyclophosphamide)
1 of 3
Experimental Treatment

This trial requires 65 total participants across 3 different treatment groups

This trial involves 3 different treatments. Single Photon Emission Computed Tomography is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Group B (VSV-IFNbeta-NIS, ruxolitinib)Patients receive VSV-IFNbeta-NIS IV over 30 minutes on day 1 and ruxolitinib phosphate PO BID on days -1 to 9. Patients undergo SPECT/CT scans at baseline, and at days 3 and 8 after VSV-IFNbeta-NIS infusion.
Group A (VSV-IFNbeta-NIS)Patients receive VSV-IFNbeta-NIS IV over 30 minutes on day 1. Patients undergo SPECT/CT scans at baseline, and at days 3 and 8 after VSV-IFNbeta-NIS infusion.
Group C (VSV-IFNbeta-NIS, ruxolitinib, cyclophosphamide)Patients receive VSV-IFNbeta-NIS IV over 30 minutes on day 1 and ruxolitinib phosphate PO BID on days -1 to 9. Patients also receive cyclophosphamide IV over 2 hours on day 2. Patients undergo SPECT/CT scans at baseline, and at days 3 and 8 after VSV-IFNbeta-NIS infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Single Photon Emission Computed Tomography
2008
Completed Phase 4
~260
Ruxolitinib
FDA approved
Computed Tomography
2017
Completed Phase 2
~3460
Cyclophosphamide
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 2 years for reporting.

Closest Location

Mayo Clinic in Arizona - Scottsdale, AZ

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for refractory, primary Cutaneous T-Cell Non-Hodgkin Lymphoma or one of the other 34 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Groups A, B, or C: Multiple myeloma (MM) previously treated with an immunomodulatory drug (IMID), a proteosome inhibitor and an alkylating agent; OR Groups A or B: Acute myeloid leukemia (AML), excluding acute promyelocytic leukemia (PML-RARA rearranged- AML-M3); either primary refractory or relapsed/refractory disease after at least two front line chemotherapy regimens (note: induction and consolidation chemotherapy is considered one line of therapy); diagnosis based on 2008 World Health Organization (WHO) criteria; OR Groups A, B, or C: Relapsed T-cell lymphoma (TCL) or the following types: peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS); angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell (ALCL), and cutaneous TCL (CTCL) of 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
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2 times upper limit of normal (ULN) (obtained =< 14 days prior to registration)
Creatinine =< 2.0 mg/dL (obtained =< 14 days prior to registration)
Direct bilirubin =< 1.5 x ULN (obtained =< 14 days prior to registration)
International normalized ratio (INR)/prothrombin time (PT) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN (obtained =< 14 days prior to registration)
If baseline liver disease, Child Pugh score not exceeding class A (obtained =< 14 days prior to registration)
Negative pregnancy test for persons of child-bearing potential (obtained =< 14 days prior to registration)
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

Patient Q&A Section

What are common treatments for refractory, primary cutaneous t-cell non-hodgkin lymphoma?

"Recent findings demonstrate the need to identify effective treatments for R/PCNTL. There appears to be a high rate of resistance to treatment even when combination therapies are offered, indicating an optimal therapeutic strategy requires development." - Anonymous Online Contributor

Unverified Answer

What causes refractory, primary cutaneous t-cell non-hodgkin lymphoma?

"Primary PCTCLs are an aggressive, chemoresistant and heterogeneous group of neoplasms and their occurrence is uncommon. For many patients with localized or regional PCTCLs the best clinical response to systemic chemotherapy is obtained with localized or regional high-dose radiotherapy alone or in conjunction with localized or regional immunotherapy." - Anonymous Online Contributor

Unverified Answer

Can refractory, primary cutaneous t-cell non-hodgkin lymphoma be cured?

"Data from a recent study of this study suggest that t-cell-based therapy is a reliable option for the treatment of refractory, primary cutaneous T-cell lymphomas, especially in patients with cutaneous T-cell lymphomas who lack traditional systemic therapy. However, longer follow-up is warranted before definitive conclusions can be made as to the best therapeutic approach." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving single photon emission computed tomography?

"As of July 2013, a total of 6 SPS trials had been conducted with only a single trial comparing multiple active agents to single agents. This low level of evidence does not allow firm conclusions to be drawn in patients with PCNSCL." - Anonymous Online Contributor

Unverified Answer

What is the latest research for refractory, primary cutaneous t-cell non-hodgkin lymphoma?

"Currently there are no studies that have identified biomarkers for refractory, primary cutaneous T-cell lymphomas. The best option for managing refractory cutaneous lymphomas is to administer chemotherapy with intralesional steroids/systemic/immunotherapy (e.g., methotrexate, rituximab, vincristine) with or without biologic therapies. This combination results in a median PFS of 16 months (range 1.5-36.5 months). The use immunotherapy in combination with chemotherapy can enhance the effect of the therapies and reduces the number of treatments, time to complete remission, and side effects." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets refractory, primary cutaneous t-cell non-hodgkin lymphoma?

"With the new NCI classification of DLBCL, the median age at the time of DLBCL diagnosis was 68 years with a median survival of 16 months. Since the time leading up to the revision of the current NCI classification of DLBCL, the median age has dropped to 60.5 years in the 2013-2015 cohort (n = 23,650) and 59 years (n = 10,532) from the first quarter (January) to 2017-2018. Patients younger than age 40 years accounted for 43% of patients in this cohort versus 30% of all patients diagnosed with DLBCL over the last decade. This has likely been because of advances in treatment of older patients for aggressive B-cell malignancies." - Anonymous Online Contributor

Unverified Answer

What are the signs of refractory, primary cutaneous t-cell non-hodgkin lymphoma?

"This report describes a patient with refractory PEZ. PEZ should be routinely included in the differential diagnosis of t-cell lymphoma irrespective of location. The presentation in the lower limb may mimic that of mycosis fungoides. This case illustrates the importance of close follow-up in the early stages of t-cell lymphoma, as its behaviour can alter quickly. Early diagnosis is critical for guiding appropriate therapy." - Anonymous Online Contributor

Unverified Answer

How many people get refractory, primary cutaneous t-cell non-hodgkin lymphoma a year in the United States?

"The most common non-Hodgkin lymphoma in this study was chronic mycosis fungoides in children and adolescents. The most common subtype of cutaneous T-cell lymphomas in children and adolescents was mycosis fungoides/Sezary syndrome. About 50% of patients with Sezary syndrome were older than 40 years old. The most common presenting feature was enlargement of lymph nodes." - Anonymous Online Contributor

Unverified Answer

What is refractory, primary cutaneous t-cell non-hodgkin lymphoma?

"T-cells in ECP infiltrate cutaneous mucosa, bone, brain, and liver. Involvement of cutaneous mucosa in diffuse infiltration without follicle formation is highly unusual. A significant proportion of our patients, regardless of age or stage, have diffuse necrosis of the overlying skin without follicle formation (as previously reported). Many of these patients are in their 40s. Although their exact pathology remains inconclusive, these patients would be eligible for an aggressive treatment regimen in most cases." - Anonymous Online Contributor

Unverified Answer

How does single photon emission computed tomography work?

"Single photon emission computed tomographic imaging can frequently locate regions of increased uptake by a small percentage of t(i)-cells, particularly in follicular variants of low-grade CTCL. In t(i)TLC, the high uptake of fluorodeoxyglucose is limited to anatomically connected regions of FDG-PET positive tissue. This indicates that single photon emission computed tomographic imaging is a useful tool, particularly in t(i)TLC." - Anonymous Online Contributor

Unverified Answer

What does single photon emission computed tomography usually treat?

"We found that many patients have an abnormal SPECT scan. Some physicians consider the scan only for those patients who may benefit from treatment, and not to ensure an accurate diagnosis. We find that most of these exams result in no change or a less favorable clinical result. Because of this, the presence of an abnormal SPECT examination may not be as important as previously thought." - Anonymous Online Contributor

Unverified Answer

Is single photon emission computed tomography typically used in combination with any other treatments?

"In the majority of cases, SLEP was not used in combination with other treatments. Only one third of the patients were treated with standard SLEP. It is difficult to make conclusions regarding the use of SLEP because only a limited number of patients could be reliably identified. We found that SLEP is less frequently used in daily clinical practice than expected." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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