Duvelisib With Obinutuzumab in Patients With CLL/SLL Previously Treated With a BTKi (SYNCHRONY)

February 24, 2023 updated by: SecuraBio

A Phase 1b Study of Duvelisib Administered in Combination With Obinutuzumab in Patients With CLL/SLL Previously Treated With a Bruton's Tyrosine Kinase Inhibitor (BTKi) (SYNCHRONY)

To evaluate the safety, pharmacokinetics, and pharmacodynamics of Duvelisib (IPI-145) in combination with obinutuzumab in patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma previously treated with a BTKi.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 1b, open-label, dose escalation, safety and tolerability study of Duvelisib (IPI-145) in combination with obinutuzumab in subjects with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma previously treated with a BTKi therapy.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
  • United States
    • California
      • La Jolla, California, United States, 92093
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
    • New York
      • New Hyde Park, New York, United States, 11042
    • Ohio
      • Columbus, Ohio, United States, 43210
    • Texas
      • Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ≥18 years of age
  • Diagnosis of Chronic lymphocytic leukemia or Small lymphocytic lymphoma that meets at least one of the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria for treatment (Binet Stage ≥ B and/or Rai Stage ≥ I with symptoms)
  • Measurable disease with a lymph node or tumor mass >1.5 cm in at least one dimension as assessed by computed tomography (CT)

  • Previous exposure to BTKi therapy and meets at least one of the below criteria:

    • Progressive disease while receiving a BTKi therapy, or stable disease as best response after 12 months of receiving a BTKi therapy
    • Discontinued a BTKi therapy due to BTKi treatment-related intolerance
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (corresponds to Karnofsky Performance Status [KPS] ≥60%)
  • Subjects must be able to receive outpatient treatment and laboratory monitoring (where specifically indicated) at the institution that administers study drug for the entire treatment period

Exclusion Criteria:

  • Richter's transformation or prolymphocytic leukemia
  • Refractory to obinutuzumab (defined as progression or relapse <12 months of receiving obinutuzumab monotherapy or <24 months of receiving an obinutuzumab-containing regimen)
  • Progressive disease while previously receiving a PI3K inhibitor (e.g. GS-1101 [idelalisib], duvelisib) or a serious/severe AE related to PI3K inhibitor treatment
  • History of severe reaction to prior monoclonal antibody therapy (defined as a Grade 4 event and/or requiring permanent discontinuation)
  • Human immunodeficiency virus (HIV) or Human T Cell Lymphotropic Virus 1 (HTLV-1) infection
  • Prior, current, or chronic hepatitis B or hepatitis C infection
  • History of tuberculosis treatment within the preceding 2 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IPI-145 in Combination with Obinutuzumab
Drug: IPI-145 (duvelisib)
25mg and/or 5mg oral capsule
Other Names:
  • Duvelisib
Drug: Obinutuzumab
1000mg/40mL single-use vials
Other Names:
  • GAZYVA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose-limiting toxicities (DLTs)
Time Frame: 28 days
28 days
Treatment-emergent adverse events (TEAEs)
Time Frame: Up to 30 days from last dose of study treatment
Up to 30 days from last dose of study treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall response rate (ORR)
Time Frame: Up to 2 years from the first dose of study treatment
Up to 2 years from the first dose of study treatment
Duration of response (DOR)
Time Frame: Up to 2 years from the first dose of study treatment
Up to 2 years from the first dose of study treatment
Progression-free survival (PFS)
Time Frame: Up to 2 years from the first dose of study treatment
Up to 2 years from the first dose of study treatment
Overall survival (OS)
Time Frame: Up to 2 years from the first dose of study treatment or until study treatment is completed, whichever is later
Up to 2 years from the first dose of study treatment or until study treatment is completed, whichever is later
BTK mutation status
Time Frame: Baseline
Baseline
Pharmacokinetic (PK) parameters of duvelisib and IPI-656 (major metabolite)
Time Frame: Week 1, Week 2, Months 2, 4, 7, 11, 15, 19
Week 1, Week 2, Months 2, 4, 7, 11, 15, 19

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SecuraBio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

November 10, 2014

First Submitted That Met QC Criteria

November 12, 2014

First Posted (Estimate)

November 17, 2014

Study Record Updates

Last Update Posted (Estimate)

February 27, 2023

Last Update Submitted That Met QC Criteria

February 24, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPI-145-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lymphoma, Small Lymphocytic

Clinical Trials on IPI-145 (duvelisib)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe