Nanatinostat in combination with valganciclovir for Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Sidney Kimmel Cancer Center - Jefferson Health, Philadelphia, PA
Lymphoma+13 More
Nanatinostat in combination with valganciclovir - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called nanatinostat can be used to treat people with EBV-positive lymphomas.

See full description

Eligible Conditions

  • Lymphoma
  • EBV-Positive DLBCL, Nos
  • EBV Related PTCL, Nos
  • EBV Associated Lymphoma
  • Epstein-Barr Virus Associated Lymphoproliferative Disorder
  • Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD)
  • EBV Related Hodgkin's Lymphoma
  • EBV Related Non-Hodgkin's Lymphoma
  • Extranodal NK/T Cell Lymphoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Nanatinostat in combination with valganciclovir will improve 1 primary outcome and 9 secondary outcomes in patients with Lymphoma. Measurement will happen over the course of Approximately 28 days following the last dose.

Day 28
Incidence and severity of treatment-emergent adverse events
Approximately 3 years
Duration of response (DOR)
Objective response rate (ORR)
Overall survival
Progression-free survival (PFS)
Time to next anti-lymphoma treatment (TTNLT)
Time to progression (TTP)
Month 6
Pharmacokinetic parameter - area under the plasma concentration-time curve [AUC]
Pharmacokinetic parameter - maximum plasma concentration [Cmax]
Pharmacokinetic parameter - time to maximum plasma concentration [tmax]

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

1 Treatment Group

Nanatinostat with Valganciclovir
1 of 1
Experimental Treatment

This trial requires 140 total participants across 1 different treatment group

This trial involves a single treatment. Nanatinostat In Combination With Valganciclovir is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Nanatinostat with Valganciclovir
Drug
Patients will receive nanatinostat 20 mg orally once daily, days 1-4 per week with valganciclovir 900 mg orally once daily. Up to 10 PTCL patients will receive nanatinostat 20 mg orally once daily, days 1-4 per week.

Trial Logistics

Trial Timeline

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

Closest Location

Sidney Kimmel Cancer Center - Jefferson Health - Philadelphia, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Lymphoma or one of the other 13 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:
You have lymphoma that is EBV+ relapsed/refractory following 2 or more prior systemic therapies. show original
EBV+ DLBCL, NOS: Must have received at least one course of an anti-CD20 immunotherapy, and at least one course of anthracycline-based chemotherapy
PTLD: Must have received immunotherapy with an anti-CD20 agent.
Hodgkin lymphoma: Must have received at least one course of anthracycline-based chemotherapy. Patients with classical Hodgkin lymphoma should have failed or be ineligible for an anti-PD-1 agent and CD30-directed therapy.
For ENKTL and PTCL patients only: Relapsed/refractory disease following 1 or more prior systemic therapies. ENKTL patients must have failed an asparaginase-containing regimen.
No available therapies in the opinion of the Investigator Not eligible for high-dose chemotherapy with allogeneic/autologous stem cell transplantation or CAR-T therapy
You have a disease that can be measured. show original
ECOG performance status 0, 1, 2
Adequate bone marrow function
Key

Patient Q&A Section

How many people get lymphoma, extranodal nk-t-cell a year in the United States?

"Data from a recent study shows that the incidence of lymphoma, extranodal nk-t-cell increased significantly over time. There was also an increase in some histologic subtypes of lymphoma and an increase in the percentage of patients who were diagnosed during the summer months." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing lymphoma, extranodal nk-t-cell?

"The risk of developing NHL in individuals with EOTL is significantly higher than the general population. This may be due to a genetic predisposition or environmental factors. Further studies are needed to confirm this association." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets lymphoma, extranodal nk-t-cell?

"The average age of diagnosis of lymphoma, extranodal nk-t-cell is 59 years old. This increases to 65 years old in people diagnosed with Hodgkin's lymphoma. In the USA, approximately 15-20% of all cases of lymphoma occur in children under 18 years. Children and adolescents are more likely to have non-Hodgkin's lymphoma than adults. People with lymphoma, extranodal nk-t-cell usually present with symptoms such as: itchiness, fever, swollen lymph nodes (both in neck and groin), pain, feeling tired, and weight loss." - Anonymous Online Contributor

Unverified Answer

Has nanatinostat in combination with valganciclovir proven to be more effective than a placebo?

"Nanatinostat combined with valganciclovir has shown promising results in treating patients with relapsed/refractory diffuse large B-cell lymphomas. The outcome of this study needs to be evaluated in the near future." - Anonymous Online Contributor

Unverified Answer

What are common treatments for lymphoma, extranodal nk-t-cell?

"Many lymphomas are treated by chemotherapy alone. Newer drugs are being developed to treat these types of cancers. If you are joining a lymphoma clinical trial, [Power] helps you find clinical trials tailored to your conditions. [Kaposi sarcoma (KS) is an uncommon cancer that affects about one percent of HIV positive men. It often spreads from the genitals to other areas in the body, such as the upper GI tract, lungs, liver, and brain. Symptoms include weight loss, night sweats, skin lesions, swollen lymph nodes, itching, fever, and fatigue. In some cases it may cause blindness. The disease progresses quickly, but the average life expectancy is still about ten years." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating lymphoma, extranodal nk-t-cell?

"A significant number of prevailing approaches have not significantly contributed to improving outcomes for patients with extranodal NKT cell lymphoma. There is a need for future research to address these issues." - Anonymous Online Contributor

Unverified Answer

Is nanatinostat in combination with valganciclovir typically used in combination with any other treatments?

"Nanatinostat combined with valganciclovir was used in combination with other treatments in the majority (81%) of patients. The use of nanatinostat in combination with other drugs is rare. The mechanism of action associated with nanatinostat requires further exploration." - Anonymous Online Contributor

Unverified Answer

Can lymphoma, extranodal nk-t-cell be cured?

"The data suggest that methotrexate as a single agent was effective enough in controlling disease progression to allow autologous stem cell transplantation to be performed successfully. It appears that those who have been treated prior to referral to the PBL were more likely to have a longer survival." - Anonymous Online Contributor

Unverified Answer

What is lymphoma, extranodal nk-t-cell?

"Patients with lymphoma, extranodal nk-t-cell, are more likely to be older, but this association is not strongly associated with progression of cancer. These data may help guide patient care and treatment decisions." - Anonymous Online Contributor

Unverified Answer

Does nanatinostat in combination with valganciclovir improve quality of life for those with lymphoma, extranodal nk-t-cell?

"Nanatinostat enhances the antiviral activity of valganciclovir against EBV in vitro. The combination of nanatinostat and valganciclovir appears promising in preclinical models for patients with lymphoma, extranodal NK-T cell Lymphoma. Clinical Trials Registration (NCT00568283)." - Anonymous Online Contributor

Unverified Answer

How serious can lymphoma, extranodal nk-t-cell be?

"The seriousness of this disease is not reported, but it seems that its seriousness depends upon many factors like age of disease onset, sex and race. In our opinion, these factors should be taken into account in order to define more precisely the seriousness of lymphoma, extranodal nk-t-cell." - 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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