Study of Duvelisib in Combination With Rituximab vs Rituximab in Subjects With Previously Treated Follicular Lymphoma

Follicular Lymphoma Clinical Trial

— DYNAMO + R  

Official 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02204982
• Other study ID #: IPI-145-08
• Secondary ID: 2013-002406-31
• Status: Terminated
• Phase: Phase 3
• Start date: September 2014
• Est. completion date: March 2017

Study information

• Verified date: September 2023
• Source: SecuraBio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Study IPI-145-08 is an international, multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study designed to evaluate the efficacy and safety of duvelisib in combination with rituximab vs placebo in combination with rituximab in subjects with previously treated CD20-positive follicular lymphoma.

Approximately 400 subjects will receive 25 mg of duvelisib or placebo, orally BID for 28 day continuous cycles, in combination with 375 mg/m2 of Rituximab given once weekly for 4 weeks during Cycle 1 and then once on Day 1 of Cycles 4, 6, 8, and 10. Patients will remain on treatment for up to 27 cycles and may continue treatment if clinical benefit is observed.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Follicular Lymphoma
• Lymphoma
• Lymphoma, Follicular

Intervention

Drug:
• Duvelisib
PI3K Inhibitor
• Placebo
Matching Placebo (25 mg BID) administered orally in 28-day continuous treatment cycles.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SecuraBio

Countries where clinical trial is conducted

Australia,  France,  Italy,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS)	Due to the small number of enrolled subjects and study being terminated, PFS endpoint analysis was not performed.	Until disease progression, for up to 5 years from randomization
Secondary	Overall Response Rate (ORR)		Until disease progression, for up to 5 years from randomization