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

Secura Bio

Status and phase

Terminated

Phase 1

Conditions

Lymphocytic Leukemia, Chronic

Lymphoma, Small Lymphocytic

Treatments

Drug: IPI-145 (duvelisib)

Drug: Obinutuzumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT02292225

IPI-145-18

Details and patient eligibility

About

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.

Full 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.

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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