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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02204982




Registration number
NCT02204982
Ethics application status
Date submitted
25/07/2014
Date registered
31/07/2014
Date last updated
3/01/2019

Titles & IDs
Public title
Study of Duvelisib in Combination With Rituximab vs Rituximab in Subjects With Previously Treated Follicular Lymphoma
Scientific title
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Duvelisib in Combination With Rituximab vs Rituximab in Subjects With Previously Treated Follicular Lymphoma
Secondary ID [1] 0 0
2013-002406-31
Secondary ID [2] 0 0
IPI-145-08
Universal Trial Number (UTN)
Trial acronym
DYNAMO + R
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Follicular Lymphoma 0 0
Condition category
Condition code
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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Duvelisib
Treatment: Drugs - Placebo
Treatment: Drugs - Rituximab

Experimental: Duvelisib + Rituximab - Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules.
Rituximab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.

Placebo Comparator: Placebo + Rituximab - Placebo is administered orally and supplied as formulated capsules to match the active 5 mg and 25 mg capsules.
Rituximab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.


Treatment: Drugs: Duvelisib
PI3K Inhibitor

Treatment: Drugs: Placebo
Matching Placebo (25 mg BID) administered orally in 28-day continuous treatment cycles.

Treatment: Drugs: Rituximab
IV infusion of rituximab (375 mg/m2) once weekly for 4 weeks during Cycle 1, then once on Day 1 of Cycles 4, 6, 8, and 10.

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

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) - Due to the small number of enrolled subjects and study being terminated, PFS endpoint analysis was not performed.
Timepoint [1] 0 0
Until disease progression, for up to 5 years from randomization
Secondary outcome [1] 0 0
Overall Response Rate (ORR)
Timepoint [1] 0 0
Until disease progression, for up to 5 years from randomization

Eligibility
Key inclusion criteria
- Diagnosis of CD20-positive FL:

- Histology grades 1, 2 or 3a

- Biopsy-confirmed histopathological diagnosis of FL. Biopsy specimen should be
obtained =2 years prior to randomization, unless medically contraindicated

- CD20 immunophenotyping performed =2 years prior to randomization

- First or subsequent relapse following at least one induction therapy regimen
containing rituximab in combination with an anthracycline or rituximab in combination
with an alkylating agent

- Patients in first relapse must be chemoresistant or intolerant to chemotherapy

- No response or disease progression = 24 months from start of last previous therapy

- At least 1 measurable disease lesion >1.5 cm in at least one diameter by CT/CT-PET or
magnetic resonance imaging (MRI) in an area of no prior radiation therapy, or in an
area that was previously irradiated that has documented progression
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Clinical evidence of other indolent forms of lymphoma (e.g., marginal zone lymphoma
[MZL], small lymphocytic lymphoma [SLL])

- Transformation to a more aggressive subtype of lymphoma or grade 3b FL

- Refractory to rituximab: defined as disease progression while receiving or within 6
months of completing either weekly rituximab induction therapy, or rituximab-based
chemoimmunotherapy induction

- Intolerance to rituximab or severe allergic or anaphylactic reaction to any humanized
or murine monoclonal antibodies

- Prior allogeneic hematopoietic stem cell transplant (HSCT)

- Known Central Nervous System (CNS) lymphoma; subjects with symptoms of CNS disease
must have a negative CT scan and negative diagnostic lumbar puncture

- Prior treatment with a PI3K inhibitor or BTK inhibitor

- History of tuberculosis within the preceding two years

- Ongoing systemic bacterial, fungal, or viral infections at randomization (defined as
requiring IV antimicrobial, antifungal or antiviral agents)

- Subjects on antimicrobial, antifungal or antiviral prophylaxis are not specifically
excluded if all other I/E criteria are met

- Prior, current, or chronic hepatitis B or hepatitis C infection, positive result for
hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) or hepatitis
C virus antibodies (HCV Ab)

- History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia
requiring medication or mechanical control within the last 6 months

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
- Frankston
Recruitment postcode(s) [1] 0 0
3199 - Frankston
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Bordeaux
Country [2] 0 0
Italy
State/province [2] 0 0
Bologna
Country [3] 0 0
Italy
State/province [3] 0 0
Terni
Country [4] 0 0
Poland
State/province [4] 0 0
Gdynia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Verastem, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A study to evaluate the safety and efficacy of duvelisib administered in combination with
rituximab vs placebo in combination with rituximab in patients with previously treated
CD20-positive follicular lymphoma who are not suitable candidates for chemotherapy.
Trial website
https://clinicaltrials.gov/show/NCT02204982
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Hagop Youssoufian, MD
Address 0 0
Verastem, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02204982