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

Lymphocytic Leukemia, Chronic Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02292225
• Other study ID #: IPI-145-18
• Status: Terminated
• Phase: Phase 1
• Start date: February 2015
• Est. completion date: November 2016

Study information

• Verified date: February 2023
• Source: SecuraBio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leukemia, Lymphocytic, Chronic, B-Cell
• Lymphocytic Leukemia, Chronic
• Lymphoma, Small Lymphocytic

Intervention

Drug:
• IPI-145 (duvelisib)
25mg and/or 5mg oral capsule
• Obinutuzumab
1000mg/40mL single-use vials

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SecuraBio

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicities (DLTs)		28 days
Primary	Treatment-emergent adverse events (TEAEs)		Up to 30 days from last dose of study treatment
Secondary	Overall response rate (ORR)		Up to 2 years from the first dose of study treatment
Secondary	Duration of response (DOR)		Up to 2 years from the first dose of study treatment
Secondary	Progression-free survival (PFS)		Up to 2 years from the first dose of study treatment
Secondary	Overall survival (OS)		Up to 2 years from the first dose of study treatment or until study treatment is completed, whichever is later
Secondary	BTK mutation status		Baseline
Secondary	Pharmacokinetic (PK) parameters of duvelisib and IPI-656 (major metabolite)		Week 1, Week 2, Months 2, 4, 7, 11, 15, 19