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A Study of Duvelisib in Participants With Refractory Indolent Non-Hodgkin Lymphoma (DYNAMO)

Primary Purpose

Indolent Non-Hodgkin Lymphoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Duvelisib
Sponsored by
SecuraBio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Indolent Non-Hodgkin Lymphoma focused on measuring PI3K Inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects who have been diagnosed with indolent NHL that has progressed.
  • Subjects must have exhibited lack of CR or PR or progression within 6 months after the last dose of a chemotherapy induction regimen or RIT.
  • Subjects must have rituximab-refractory disease, defined as lack of CR or PR or PD within 6 months of last dose.
  • Measurable disease with a lymph node or tumor mass ≥1.5 cm in at least one dimension by CT, PET/CT or MRI.
  • Adequate renal and hepatic function.

Exclusion Criteria:

  • Candidate for potentially curative therapies in the opinion of the investigator.
  • Previous treatment with a PI3K inhibitor or BTK inhibitor.
  • Prior history of allogeneic hematopoietic stem cell transplant (HSCT).
  • Prior chemotherapy, cancer immunosuppressive therapy, or other investigational agents within 4 weeks before first dose of study drug.
  • Grade 3B FL and/or clinical evidence of transformation to a more aggressive subtype of lymphoma.
  • Symptomatic central nervous system (CNS) NHL.
  • Ongoing systemic bacterial, fungal, or viral infections at the time of initiation of study treatment.
  • Prior, current, or chronic hepatitis B or hepatitis C infection, positive result for hepatitis C virus antibodies (HCV Ab) or hepatitis B surface antigen (HBsAg) or hepatitis B core antibodies (HBcAb)
  • History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months prior to first dose of study drug

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Duvelisib

Arm Description

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR)
ORR, defined as the total percentage of participants who had a best overall response of either complete response (CR) or partial response (PR), was evaluated locally (investigator's assessment) according to the revised IWG Response Criteria for Malignant Lymphoma. ORR is reported with a 2-sided 95% exact confidence interval.

Secondary Outcome Measures

Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A TEAE was defined as any adverse event that emerged or worsened in the period from the first dose of study treatment to 30 days after the last dose of study treatment. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Duration of Response (DOR)
DOR, defined as the time from the first documentation of response to either progressive disease (PD) or death due to any cause, was evaluated locally (investigator's assessment) according to the revised IWG Response Criteria for Malignant Lymphoma.
Progression-free Survival (PFS)
PFS, defined as the time from the first dose of study treatment to the first documentation of either Investigator-assessed PD or death resulting from any cause, was evaluated locally (investigator's assessment) according to the revised IWG Response Criteria for Malignant Lymphoma.
Overall Survival (OS)
OS, defined as the time from the first dose of study treatment to the date of death, was evaluated locally (investigator's assessment) according to the revised IWG Response Criteria for Malignant Lymphoma.
Plasma Concentration of Duvelisib and IPI-656
The serum concentration of duvelisib and its main metabolite, IPI-656, are reported for Day 15 of Cycle 1 (C1D15) and Day 1 of Cycle 2 (C2D1) and Day 1 of Cycle 3 (C3D1). Results are reported in nanograms/milliliter (ng/mL).
Time to Response (TTR)
TTR, defined as the time from the first dose of study treatment to the first documentation of response, was evaluated by an independent, third-party panel of radiologists and oncologists (Independent Review Committee [IRC]) according to the revised IWG Response Criteria for Malignant Lymphoma.

Full Information

First Posted
May 31, 2013
Last Updated
September 5, 2023
Sponsor
SecuraBio
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1. Study Identification

Unique Protocol Identification Number
NCT01882803
Brief Title
A Study of Duvelisib in Participants With Refractory Indolent Non-Hodgkin Lymphoma
Acronym
DYNAMO
Official Title
A Phase 2 Study of Duvelisib in Subjects With Refractory Indolent Non-Hodgkin Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 17, 2013 (Actual)
Primary Completion Date
November 18, 2020 (Actual)
Study Completion Date
November 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SecuraBio

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This was a Phase 2 clinical trial to evaluate the safety and efficacy of duvelisib as a monotherapy in participants with indolent non-Hodgkin lymphoma (iNHL) (follicular lymphoma [FL], marginal zone lymphoma, or small lymphocytic lymphoma) that was refractory to rituximab and to either chemotherapy or radioimmunotherapy (RIT).
Detailed Description
This was an open-label, single-arm safety and efficacy study of duvelisib administered orally to participants who had been diagnosed with iNHL whose disease was refractory to rituximab and to either chemotherapy or RIT. Approximately 120 participants received 25 milligrams of duvelisib twice daily over the course of 28-day treatment cycles for up to 13 cycles. After completing 13 treatment cycles of duvelisib, participants continued to receive additional cycles of duvelisib until disease progression or unacceptable toxicity. However, to receive additional cycles of duvelisib beyond 13 cycles, participants must have had evidence of response (complete response [CR] or partial response [PR]) or stable disease according to the International Working Group criteria by the end of Cycle 13.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Indolent Non-Hodgkin Lymphoma
Keywords
PI3K Inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Duvelisib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Duvelisib
Other Intervention Name(s)
Copiktra, IPI-145
Intervention Description
Phosphoinositide-3-kinase (PI3K) inhibitor
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
ORR, defined as the total percentage of participants who had a best overall response of either complete response (CR) or partial response (PR), was evaluated locally (investigator's assessment) according to the revised IWG Response Criteria for Malignant Lymphoma. ORR is reported with a 2-sided 95% exact confidence interval.
Time Frame
Every 8-16 weeks while on treatment with duvelisib for up to 72 months
Secondary Outcome Measure Information:
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Description
An adverse event was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A TEAE was defined as any adverse event that emerged or worsened in the period from the first dose of study treatment to 30 days after the last dose of study treatment. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Time Frame
Every 2-8 weeks for up to 73 months
Title
Duration of Response (DOR)
Description
DOR, defined as the time from the first documentation of response to either progressive disease (PD) or death due to any cause, was evaluated locally (investigator's assessment) according to the revised IWG Response Criteria for Malignant Lymphoma.
Time Frame
Every 8-16 weeks for up to 72 months
Title
Progression-free Survival (PFS)
Description
PFS, defined as the time from the first dose of study treatment to the first documentation of either Investigator-assessed PD or death resulting from any cause, was evaluated locally (investigator's assessment) according to the revised IWG Response Criteria for Malignant Lymphoma.
Time Frame
Every 8-16 weeks for up to 72 months
Title
Overall Survival (OS)
Description
OS, defined as the time from the first dose of study treatment to the date of death, was evaluated locally (investigator's assessment) according to the revised IWG Response Criteria for Malignant Lymphoma.
Time Frame
Every 16 weeks for up to 72 months
Title
Plasma Concentration of Duvelisib and IPI-656
Description
The serum concentration of duvelisib and its main metabolite, IPI-656, are reported for Day 15 of Cycle 1 (C1D15) and Day 1 of Cycle 2 (C2D1) and Day 1 of Cycle 3 (C3D1). Results are reported in nanograms/milliliter (ng/mL).
Time Frame
Every 4 weeks for 12 weeks (C1D15: predose, 1 and 4 hours post dose; C2D1 and C3D1: anytime during study visit)
Title
Time to Response (TTR)
Description
TTR, defined as the time from the first dose of study treatment to the first documentation of response, was evaluated by an independent, third-party panel of radiologists and oncologists (Independent Review Committee [IRC]) according to the revised IWG Response Criteria for Malignant Lymphoma.
Time Frame
First dose to first documentation of complete or partial response (up to 6 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants who had been diagnosed with iNHL that had progressed. Participants must have exhibited lack of CR or progressive disease (PR) or progression within 6 months after the last dose of a chemotherapy induction regimen or RIT. Participants must have had rituximab-refractory disease, defined as lack of CR or PR or PD within 6 months of last dose. Measurable disease with a lymph node or tumor mass ≥1.5 centimeters in at least one dimension by computed tomography (CT), positron emission tomography/CT or magnetic resonance imaging. Adequate renal and hepatic function. Exclusion Criteria: Candidate for potentially curative therapies in the opinion of the investigator. Previous treatment with a PI3K inhibitor or Bruton's tyrosine kinase inhibitor. Prior history of allogeneic hematopoietic stem cell transplant. Prior chemotherapy, cancer immunosuppressive therapy, or other investigational agents within 4 weeks before first dose of study drug. Grade 3B FL and/or clinical evidence of transformation to a more aggressive subtype of lymphoma. Symptomatic central nervous system NHL. Ongoing systemic bacterial, fungal, or viral infections at the time of initiation of study treatment. Prior, current, or chronic hepatitis B or hepatitis C infection, positive result for hepatitis C virus antibodies, hepatitis B surface antigen, or hepatitis B core antibodies. History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months prior to first dose of study drug.
Facility Information:
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-6984
Country
United States
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
39916
Country
United States
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Howell
State/Province
New Jersey
ZIP/Postal Code
07731
Country
United States
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11510
Country
United States
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
City
Lawton
State/Province
Oklahoma
ZIP/Postal Code
73505
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
01911
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
City
Lesnoy
State/Province
Minsk Region
ZIP/Postal Code
223040
Country
Belarus
City
Brest
ZIP/Postal Code
224027
Country
Belarus
City
Minsk
ZIP/Postal Code
220013
Country
Belarus
City
Vitebsk
ZIP/Postal Code
210603
Country
Belarus
City
Gent
ZIP/Postal Code
9000
Country
Belgium
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
City
Gatineau
State/Province
Quebec
ZIP/Postal Code
J8P7H2
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
City
Brno
ZIP/Postal Code
625-00
Country
Czechia
City
Ostrava-Poruba
ZIP/Postal Code
708-52
Country
Czechia
City
Angers Cedex 09
ZIP/Postal Code
49933
Country
France
City
Bordeaux
ZIP/Postal Code
33076
Country
France
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
City
Marseille
ZIP/Postal Code
13005
Country
France
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
City
Bologna
ZIP/Postal Code
40138
Country
Italy
City
Brescia
ZIP/Postal Code
25123
Country
Italy
City
Busto Arsizio
ZIP/Postal Code
21052
Country
Italy
City
Genova
ZIP/Postal Code
16132
Country
Italy
City
Meldola
ZIP/Postal Code
47014
Country
Italy
City
Milano
ZIP/Postal Code
20162
Country
Italy
City
Modena
ZIP/Postal Code
41124
Country
Italy
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
City
Parma
ZIP/Postal Code
43100
Country
Italy
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
City
Rimini
ZIP/Postal Code
47923
Country
Italy
City
Varese
ZIP/Postal Code
21100
Country
Italy
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Madrid
ZIP/Postal Code
28222
Country
Spain
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
City
Cardiff
ZIP/Postal Code
CF 14 4XW
Country
United Kingdom
City
Chelsea
Country
United Kingdom
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
City
London
ZIP/Postal Code
W1G 6AD
Country
United Kingdom
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
30742566
Citation
Flinn IW, Miller CB, Ardeshna KM, Tetreault S, Assouline SE, Mayer J, Merli M, Lunin SD, Pettitt AR, Nagy Z, Tournilhac O, Abou-Nassar KE, Crump M, Jacobsen ED, de Vos S, Kelly VM, Shi W, Steelman L, Le N, Weaver DT, Lustgarten S, Wagner-Johnston ND, Zinzani PL. DYNAMO: A Phase II Study of Duvelisib (IPI-145) in Patients With Refractory Indolent Non-Hodgkin Lymphoma. J Clin Oncol. 2019 Apr 10;37(11):912-922. doi: 10.1200/JCO.18.00915. Epub 2019 Feb 11. Erratum In: J Clin Oncol. 2019 Jun 1;37(16):1448.
Results Reference
derived

Learn more about this trial

A Study of Duvelisib in Participants With Refractory Indolent Non-Hodgkin Lymphoma

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