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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.

Tracking Information
First Submitted Date  ICMJE August 2, 2021
First Posted Date  ICMJE August 18, 2021
Last Update Posted Date May 1, 2024
Actual Study Start Date  ICMJE May 28, 2021
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2022)		 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)
Original Primary Outcome Measures  ICMJE
 (submitted: August 11, 2021)		 Objective response rate (ORR) [ Time Frame: Approxiately 3 years ]
Assessed by an Independent Review Committee (IRC) per the 2007 International Working Group Response Criteria (IWGRC)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2022)
  • Duration of response (DOR) [ Time Frame: Approximately 3 years ]
  • Time to next anti-lymphoma treatment (TTNLT) [ Time Frame: Approximately 3 years ]
  • Progression-free survival (PFS) [ Time Frame: Approximately 3 years ]
  • Time to progression (TTP) [ Time Frame: Approximately 3 years ]
  • Overall survival [ Time Frame: Approximately 3 years ]
  • Incidence and severity of treatment-emergent adverse events [ Time Frame: Approximately 28 days following the last dose ]
  • 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) ]
  • Pharmacokinetic parameter - maximum plasma concentration [Cmax] [ Time Frame: Approximately 6 months following the end of Cycle 1 Day 1 (each cycle is 28 days) ]
  • 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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2021)
  • Duration of response (DOR) [ Time Frame: Approxiately 3 years ]
  • Time to next anti-lymphoma treatment (TTNLT) [ Time Frame: Approxiately 3 years ]
  • Progression-free survival (PFS) [ Time Frame: Approxiately 3 years ]
  • Time to progression (TTP) [ Time Frame: Approxiately 3 years ]
  • Overall survival [ Time Frame: Approxiately 3 years ]
  • Incidence and severity of treatment-emergent adverse events [ Time Frame: Approxiately 28 days following the last dose ]
  • Pharmacokinetic parameter - time to maximum plasma concentration [tmax], [ Time Frame: Approxiately 6 months following the end of Cycle 1 Day 1 (each cycle is 28 days) ]
  • Pharmacokinetic parameter - maximum plasma concentration [Cmax] [ Time Frame: Approxiately 6 months following the end of Cycle 1 Day 1 (each cycle is 28 days) ]
  • Pharmacokinetic parameter - area under the plasma concentration-time curve [AUC] [ Time Frame: Approxiately 6 months following the end of Cycle 1 Day 1 (each cycle is 28 days) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas
Official Title  ICMJE An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas
Brief Summary A Phase 2 study to evaluate the efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive lymphomas
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • 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
Intervention  ICMJE 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
Study Arms  ICMJE 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.

Intervention: Drug: Nanatinostat in combination with valganciclovir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 11, 2021)		 140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2026
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Strait Hicklin 858-400-8470 ClinicalTrials@Viracta.com
Listed Location Countries  ICMJE Australia,   Brazil,   Canada,   France,   Germany,   Hong Kong,   Israel,   Italy,   Korea, Republic of,   Malaysia,   Singapore,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05011058
Other Study ID Numbers  ICMJE VT3996-202
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Viracta Therapeutics, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Viracta Therapeutics, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Donald (D.K.) Strickland, MD Viracta Therapeutics
PRS Account Viracta Therapeutics, Inc.
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP