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An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas (NAVAL-1)

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ClinicalTrials.gov Identifier: NCT05011058
Recruitment Status : Recruiting
First Posted : August 18, 2021
Last Update Posted : May 1, 2024
Sponsor:
Information provided by (Responsible Party):
Viracta Therapeutics, Inc.

Study Description
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Brief Summary:
A Phase 2 study to evaluate the efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive lymphomas

Condition or disease Intervention/treatment Phase
Epstein-Barr Virus Associated Lymphoproliferative Disorder EBV-Related PTLD EBV Related Non-Hodgkin's Lymphoma EBV-Positive DLBCL, NOS EBV Associated Lymphoma EBV Related PTCL, NOS Drug: Nanatinostat in combination with valganciclovir Phase 2

Detailed Description:

Patients with EBV-associated lymphomas have inferior outcomes with standard-of-care therapies compared to those with EBV-negative disease. Nanatinostat is a selective class I HDAC inhibitor which induces EBV lytic phase protein generation, activating (val)ganciclovir to its cytotoxic form. This open-label, multicenter, multinational, single-arm, Phase 2 basket study employs a Simon's 2-stage design to allow termination of enrollment into cohorts where treatment appears futile, and will include the following cohorts of patients with EBV+ relapsed/refractory lymphomas:

  1. EBV+ diffuse large B-cell lymphoma (DLBCL, NOS)
  2. Peripheral T-cell lymphoma (PTCL), including PTCL-NOS and AITL
  3. Post-transplant lymphoproliferative disorder (PTLD)
  4. EBV+ lymphoproliferative disorders other than the above, including Extranodal NK/T-cell lymphoma (ENKTL)
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is an open-label, single-arm study utilizing a basket trial design.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas
Actual Study Start Date : May 28, 2021
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Nanatinostat with Valganciclovir

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.

 Drug: Nanatinostat in combination with valganciclovir

Drug: Nanatinostat, 20 mg orally once daily, 4 days per week in 28 day cycles

Other name: VRx-3996

Drug: Valganciclovir, 900 mg orally once daily in 28 day cycles


Outcome Measures
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Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: Approximately 3 years ]
    Assessed by an Independent Review Committee (IRC) per the 2007 International Working Group Response Criteria (IWGRC)


Secondary Outcome Measures :
  1. Duration of response (DOR) [ Time Frame: Approximately 3 years ]
  2. Time to next anti-lymphoma treatment (TTNLT) [ Time Frame: Approximately 3 years ]
  3. Progression-free survival (PFS) [ Time Frame: Approximately 3 years ]
  4. Time to progression (TTP) [ Time Frame: Approximately 3 years ]
  5. Overall survival [ Time Frame: Approximately 3 years ]
  6. Incidence and severity of treatment-emergent adverse events [ Time Frame: Approximately 28 days following the last dose ]
  7. Pharmacokinetic parameter - time to maximum plasma concentration [tmax], [ Time Frame: Approximately 6 months following the end of Cycle 1 Day 1 (each cycle is 28 days) ]
  8. Pharmacokinetic parameter - maximum plasma concentration [Cmax] [ Time Frame: Approximately 6 months following the end of Cycle 1 Day 1 (each cycle is 28 days) ]
  9. Pharmacokinetic parameter - area under the plasma concentration-time curve [AUC] [ Time Frame: Approximately 6 months following the end of Cycle 1 Day 1 (each cycle is 28 days) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • EBV+ DLBCL, NOS and PTCL, NOS, and AITL: Relapsed/refractory disease following 1 or more prior systemic therapy(ies) with curative intent.
  • For EBV+ PTLD patients: Relapsed/refractory disease following 1 prior therapy and must have received at least 1 course of an anti-CD20 immunotherapy. For patients with EBV+ PTLD only, age 12 years and older and weighing greater than 40 kg (Adolescent, Adult, Older Adult) are allowed
  • For other EBV+ relapsed/refractory lymphoma: Following at least 1 course of an anit-CD20 immunotherapy and at least 1 course of anthracycline-based chemotherapy (unless contraindicated)
  • 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
  • Measurable disease per Cheson 2007
  • ECOG performance status 0, 1, 2
  • Adequate bone marrow function

Key Exclusion Criteria:

  • Presence or history of CNS involvement by lymphoma
  • Systemic anticancer therapy or CAR-T within 21 days
  • Antibody (anticancer) agents within 28 days
  • Less than 60 days from prior autologous hematopoietic stem cell or solid organ transplant
  • Less than 90 days from prior allogeneic transplant.
  • Daily corticosteroids (≥20 mg of prednisone or equivalent) within week prior to Cycle 1 Day 1
  • Inability to take oral medication, malabsorption syndrome or any other gastrointestinal condition (nausea, diarrhea, vomiting) that may impact the absorption of nanatinostat and valganciclovir.
  • Active infection requiring systemic therapy (excluding viral upper respiratory tract infections).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05011058


Contacts
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Contact: Strait Hicklin 858-400-8470 ClinicalTrials@Viracta.com

Locations
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Sponsors and Collaborators
Viracta Therapeutics, Inc.
Investigators
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Study Director: Donald (D.K.) Strickland, MD Viracta Therapeutics
More Information
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Responsible Party: Viracta Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05011058    
Other Study ID Numbers: VT3996-202
First Posted: August 18, 2021    Key Record Dates
Last Update Posted: May 1, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Viracta Therapeutics, Inc.:
EBV positive post-transplant lymphoproliferative disorder (PTLD)
EBV lymphoma
Lymphoproliferative Disorders
Epstein-Barr Virus (EBV)
 EBV positive T cell lymphoma
EBV positive diffuse large B-cell lymphoma (DLBCL)
EBV positive peripheral T-cell lymphoma (PTCL)
EBV positive PTLD in Pediatrics
Additional relevant MeSH terms:
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Epstein-Barr Virus Infections
Lymphoma
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Neoplasms
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Virus Diseases
Infections
Herpesviridae Infections
DNA Virus Infections
Tumor Virus Infections
Valganciclovir
Antiviral Agents
Anti-Infective Agents