Clincosm LogoSign in Get a demo

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

Sponsor
SecuraBio (Industry)
Overall Status
Terminated
CT.gov ID
NCT02292225
Collaborator
(none)
3
Enrollment
7
Locations
1
Arm
21
Duration (Months)
0.4
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
3 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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)
Study Start Date :
Feb 1, 2015
Actual Primary Completion Date :
Nov 1, 2016
Actual Study Completion Date :
Nov 1, 2016

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Dose-limiting toxicities (DLTs) [28 days]

    2. Treatment-emergent adverse events (TEAEs) [Up to 30 days from last dose of study treatment]

    Secondary Outcome Measures

    1. Overall response rate (ORR) [Up to 2 years from the first dose of study treatment]

    2. Duration of response (DOR) [Up to 2 years from the first dose of study treatment]

    3. Progression-free survival (PFS) [Up to 2 years from the first dose of study treatment]

    4. Overall survival (OS) [Up to 2 years from the first dose of study treatment or until study treatment is completed, whichever is later]

    5. BTK mutation status [Baseline]

    6. Pharmacokinetic (PK) parameters of duvelisib and IPI-656 (major metabolite) [Week 1, Week 2, Months 2, 4, 7, 11, 15, 19]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 La Jolla California United States 92093
    2 Boston Massachusetts United States 02115
    3 Hackensack New Jersey United States 07601
    4 New Hyde Park New York United States 11042
    5 Columbus Ohio United States 43210
    6 Houston Texas United States 77030
    7 Montreal Quebec Canada H3T 1E2

    Sponsors and Collaborators

    • SecuraBio

    Investigators

    • Study Director: David Cohan, MD, SecuraBio Chief Medical Officer

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    SecuraBio
    ClinicalTrials.gov Identifier:
    NCT02292225
    Other Study ID Numbers:
    • IPI-145-18
    First Posted:
    Nov 17, 2014
    Last Update Posted:
    Mar 17, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by SecuraBio
    Phase 1b, CLL/SLL, PI3K
    Additional relevant MeSH terms:
    Leukemia, Lymphocytic, Chronic, B-Cell
    Obinutuzumab

    Study Results

    No Results Posted as of Mar 17, 2021