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Trial record 1 of 1 for:    SYNCHRONY Duvelisib
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Duvelisib With Obinutuzumab in Patients With CLL/SLL Previously Treated With a BTKi (SYNCHRONY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02292225
Recruitment Status : Terminated (The scope of the program has been reduced to focus resources on studies which can potentially enable the registration of duvelisib.)
First Posted : November 17, 2014
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Verastem, Inc.

Tracking Information
First Submitted Date  ICMJE November 10, 2014
First Posted Date  ICMJE November 17, 2014
Last Update Posted Date October 16, 2018
Study Start Date  ICMJE February 2015
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2014)
  • Dose-limiting toxicities (DLTs) [ Time Frame: 28 days ]
  • Treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 30 days from last dose of study treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02292225 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2014)
  • Overall response rate (ORR) [ Time Frame: 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 ]
  • Progression-free survival (PFS) [ Time Frame: 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 ]
  • BTK mutation status [ Time Frame: Baseline ]
  • Pharmacokinetic (PK) parameters of duvelisib and IPI-656 (major metabolite) [ Time Frame: Week 1, Week 2, Months 2, 4, 7, 11, 15, 19 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Duvelisib With Obinutuzumab in Patients With CLL/SLL Previously Treated With a BTKi (SYNCHRONY)
Official Title  ICMJE 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)
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lymphocytic Leukemia, Chronic
  • Lymphoma, Small Lymphocytic
Intervention  ICMJE
  • Drug: IPI-145 (duvelisib)
    25mg and/or 5mg oral capsule
    Other Name: Duvelisib
  • Drug: Obinutuzumab
    1000mg/40mL single-use vials
    Other Name: GAZYVA
Study Arms  ICMJE Experimental: IPI-145 in Combination with Obinutuzumab
Interventions:
  • Drug: IPI-145 (duvelisib)
  • Drug: Obinutuzumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 22, 2016)
3
Original Estimated Enrollment  ICMJE
 (submitted: November 12, 2014)
64
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02292225
Other Study ID Numbers  ICMJE IPI-145-18
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Verastem, Inc.
Study Sponsor  ICMJE Verastem, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Hagop Youssoufian, MD Verastem, Inc.
PRS Account Verastem, Inc.
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP