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

NCT02292225 | Terminated Phase 1

• 1 other identifier: IPI-145-18
• Study Type: interventional
• Target: 3
• Locations: 2 countries
• Sites: 7

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.

Conditions

Lymphocytic Leukemia, Chronic; Lymphoma, Small Lymphocytic

Keywords

Phase 1b, CLL/SLL, PI3K

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicities (DLTs)

  28 days

• Treatment-emergent adverse events (TEAEs)

  Up to 30 days from last dose of study treatment

Secondary Outcomes (6)

• Overall response rate (ORR)

  Up to 2 years from the first dose of study treatment

• Duration of response (DOR)

  Up to 2 years from the first dose of study treatment

• Progression-free survival (PFS)

  Up to 2 years from the first dose of study treatment

• Overall survival (OS)

  Up to 2 years from the first dose of study treatment or until study treatment is completed, whichever is later

• BTK mutation status

  Baseline

Study Arms (1)

IPI-145 in Combination with Obinutuzumab

EXPERIMENTAL

Drug: IPI-145 (duvelisib); Drug: Obinutuzumab

Interventions

IPI-145 (duvelisib) DRUG

25mg and/or 5mg oral capsule

Also known as: Duvelisib

IPI-145 in Combination with Obinutuzumab

Obinutuzumab DRUG

1000mg/40mL single-use vials

Also known as: GAZYVA

IPI-145 in Combination with Obinutuzumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• SecuraBio: lead

Study Sites (7)

Unknown Facility

La Jolla, California, 92093, United States

Location

Unknown Facility

Boston, Massachusetts, 02115, United States

Location

Unknown Facility

Hackensack, New Jersey, 07601, United States

Location

Unknown Facility

New Hyde Park, New York, 11042, United States

Location

Unknown Facility

Columbus, Ohio, 43210, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Hereditary Sensory and Autonomic Neuropathies

Interventions

duvelisib; obinutuzumab

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2014
• First Posted: November 17, 2014
• Study Start: February 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: February 27, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (6)