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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05011058




Registration number
NCT05011058
Ethics application status
Date submitted
2/08/2021
Date registered
18/08/2021

Titles & IDs
Public title
An Open-Label, Phase 2 Trial of Nanatinostat in Combination with Valganciclovir in Patients with Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas
Scientific title
An Open-Label, Phase 2 Trial of Nanatinostat in Combination with Valganciclovir in Patients with Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas
Secondary ID [1] 0 0
VT3996-202
Universal Trial Number (UTN)
Trial acronym
NAVAL-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epstein-Barr Virus Associated Lymphoproliferative Disorder 0 0
EBV-Related PTLD 0 0
EBV Related Non-Hodgkin's Lymphoma 0 0
EBV-Positive DLBCL, NOS 0 0
EBV Associated Lymphoma 0 0
EBV Related PTCL, NOS 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nanatinostat in combination with valganciclovir

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.


Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective response rate (ORR)
Timepoint [1] 0 0
Approximately 3 years
Secondary outcome [1] 0 0
Duration of response (DOR)
Timepoint [1] 0 0
Approximately 3 years
Secondary outcome [2] 0 0
Time to next anti-lymphoma treatment (TTNLT)
Timepoint [2] 0 0
Approximately 3 years
Secondary outcome [3] 0 0
Progression-free survival (PFS)
Timepoint [3] 0 0
Approximately 3 years
Secondary outcome [4] 0 0
Time to progression (TTP)
Timepoint [4] 0 0
Approximately 3 years
Secondary outcome [5] 0 0
Overall survival
Timepoint [5] 0 0
Approximately 3 years
Secondary outcome [6] 0 0
Incidence and severity of treatment-emergent adverse events
Timepoint [6] 0 0
Approximately 28 days following the last dose
Secondary outcome [7] 0 0
Pharmacokinetic parameter - time to maximum plasma concentration [tmax],
Timepoint [7] 0 0
Approximately 6 months following the end of Cycle 1 Day 1 (each cycle is 28 days)
Secondary outcome [8] 0 0
Pharmacokinetic parameter - maximum plasma concentration [Cmax]
Timepoint [8] 0 0
Approximately 6 months following the end of Cycle 1 Day 1 (each cycle is 28 days)
Secondary outcome [9] 0 0
Pharmacokinetic parameter - area under the plasma concentration-time curve [AUC]
Timepoint [9] 0 0
Approximately 6 months following the end of Cycle 1 Day 1 (each cycle is 28 days)

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Box Hill Hospital - Melbourne
Recruitment hospital [2] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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Arizona
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California
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Colorado
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Florida
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Georgia
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Kentucky
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Maryland
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Montana
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New Hampshire
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New Jersey
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New York
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North Carolina
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Ohio
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Pennsylvania
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South Carolina
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Texas
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Utah
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Washington
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Brazil
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Joinville
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Brazil
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Rio De Janeiro
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Brazil
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Santo André
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Brazil
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São Paulo
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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France
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Aquitaine
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France
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Ile-de-France
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France
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Limousin
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France
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Nouvelle-Aquitaine
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France
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Pays de la loire
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France
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Provence Alpes Cote d'Azur
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France
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Rhone-Alps
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Marseille
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France
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Paris
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Germany
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Bavaria
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Germany
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Niedersachsen
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Germany
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Nordrhein-Westfalen
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Germany
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Saxony
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Germany
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Bremen
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Germany
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Halle
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Germany
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Leipzig
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Germany
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Mannheim
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Hong Kong
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Hong Kong
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Israel
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Jerusalem
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Foggia
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Pordenone
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Italy
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Bologna
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Brescia
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Italy
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Milano
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Italy
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Pavia
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Italy
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Reggio Emilia
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Italy
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Roma
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Korea, Republic of
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Gyeongsangbugdo
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Korea, Republic of
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Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Malaysia
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Kuala Lumpur
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Malaysia
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Kuching
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Singapore
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Singapore
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Spain
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Barcelona
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Spain
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Madrid
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Taiwan
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Taipei
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Taiwan
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Kaohsiung
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Taiwan
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Taichung City
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Taiwan
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Tainan
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Taiwan
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Taipei City
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Taiwan
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Taoyuan City
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United Kingdom
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Liverpool
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United Kingdom
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London
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United Kingdom
State/province [74] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Viracta Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Darrel P Cohen, MD, PhD
Address 0 0
Viracta Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Strait Hicklin
Address 0 0
Country 0 0
Phone 0 0
858-400-8470
Fax 0 0
Email 0 0
ClinicalTrials@Viracta.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05011058