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

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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.

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
Lymphocytic Leukemia, Chronic Lymphoma, Small Lymphocytic Drug: IPI-145 (duvelisib) Drug: Obinutuzumab 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
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 : February 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IPI-145 in Combination with Obinutuzumab Drug: IPI-145 (duvelisib)
25mg and/or 5mg oral capsule
Other Name: Duvelisib

Drug: Obinutuzumab
1000mg/40mL single-use vials
Other Name: GAZYVA




Primary Outcome Measures :
  1. Dose-limiting toxicities (DLTs) [ Time Frame: 28 days ]
  2. Treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 30 days from last dose of study treatment ]

Secondary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: Up to 2 years from the first dose of study treatment ]
  2. Duration of response (DOR) [ Time Frame: Up to 2 years from the first dose of study treatment ]
  3. Progression-free survival (PFS) [ Time Frame: Up to 2 years from the first dose of study treatment ]
  4. 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 ]
  5. BTK mutation status [ Time Frame: Baseline ]
  6. Pharmacokinetic (PK) parameters of duvelisib and IPI-656 (major metabolite) [ Time Frame: Week 1, Week 2, Months 2, 4, 7, 11, 15, 19 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02292225


Locations
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United States, California
La Jolla, California, United States, 92093
United States, Massachusetts
Boston, Massachusetts, United States, 02115
United States, New Jersey
Hackensack, New Jersey, United States, 07601
United States, New York
New Hyde Park, New York, United States, 11042
United States, Ohio
Columbus, Ohio, United States, 43210
United States, Texas
Houston, Texas, United States, 77030
Canada, Quebec
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Verastem, Inc.
Investigators
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Study Chair: Hagop Youssoufian, MD Verastem, Inc.

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Responsible Party: Verastem, Inc.
ClinicalTrials.gov Identifier: NCT02292225     History of Changes
Other Study ID Numbers: IPI-145-18
First Posted: November 17, 2014    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Verastem, Inc.:
Phase 1b, CLL/SLL, PI3K
Additional relevant MeSH terms:
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Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Obinutuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents