A Study of Duvelisib and Venetoclax in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Indolent or Aggressive Non-Hodgkin Lymphoma, Who Have Not Previously Received a Bcl-2 or PI3K Inhibitor

NCT ID: NCT02640833

Last Updated: 2016-07-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2021-02-28

Brief Summary

This study is designed to assess the safety, pharmacokinetics, drug-drug interactions, and determine the recommended Phase 2 doses of co administered Duvelisib and Venetoclax in participants with relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma, or indolent or aggressive non-Hodgkin lymphoma, who have not previously received a Bcl-2 or Phosphoinositide 3-kinase (PI3K) inhibitor. The Phase 2 portion of the study will preliminarily evaluate efficacy, and expand the toxicity evaluation.

Conditions

Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; Non-Hodgkin Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Duvelisib+Venetoclax

Group Type: EXPERIMENTAL

Duvelisib

Intervention Type: DRUG

Duvelisib will be taken continuously. This is a defining dose study, therefore the dose of Duvelisib may change.

Venetoclax

Intervention Type: DRUG

Venetoclax will be taken continuously. This is a defining dose study, therefore the dose of Venetoclax will change.

Interventions

Duvelisib

Duvelisib will be taken continuously. This is a defining dose study, therefore the dose of Duvelisib may change.

Intervention Type: DRUG

Venetoclax

Venetoclax will be taken continuously. This is a defining dose study, therefore the dose of Venetoclax will change.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Subject must have either • Relapsed or refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (for Waves 2 or 3)

• Subject has evaluable disease and requires treatment in the opinion of the investigator.
• Subject must have relapsed following or be refractory to ≥ 1 standard treatments such as fludarabine based regimens (F, FC, FR, FCR), alkylator (chlorambucil, bendamustine) based regimens, or Bruton's Tyrosine Kinase inhibitor (Ibrutinib).

Or

• Relapsed or refractory indolent Non-Hodgkin Lymphoma or aggressive Non-Hodgkin Lymphoma (for Waves 1, 2, or 3, unless otherwise indicated)

• Subject must have histologically documented diagnosis of a Follicular Lymphoma or Marginal Zone Lymphoma.
• Subject must have histologically documented diagnosis of a Diffuse Large B-cell Lymphoma (excluding Richter's Transformation), Non-cutaneous T-Cell Lymphoma, or Mantle Cell Lymphoma (MCL) (MCL Wave 3 only)
• Subject has evaluable disease and requires treatment in the opinion of the investigator.
• Subject must have relapsed following or be refractory to ≥ 1 standard treatments such as R-CHOP, R-CVP, bendamustine, lenalidomide-rituximab, or fludarabine-based regimens.

• Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2.
• Subject must have adequate bone marrow independent of growth factor support per local laboratory reference range at Screening.
• Subject must have adequate coagulation, renal, and hepatic function, per laboratory reference range at Screening.
• NHL subjects who have a history of an autologous stem cell transplant (e.g., bone marrow) must be > 6 months post-transplant (prior to the first dose of study drug) and must not require any growth factor support.

Exclusion Criteria

• Subject has been previously treated with a Bcl-2 or PI3K inhibitor.
• Subject is a candidate to receive another second-line therapy approved for usage by the local Health Authority.
• Subject is appropriate for a stem cell transplant or has undergone an allogeneic stem cell transplant.
• Subject has received any of the following within 14 days or 5 drug half-lives (whichever is shortest) prior to the first dose of duvelisib or venetoclax, or has not recovered to less than Grade 2 clinically significant adverse effect(s)/toxicity(s) of the previous therapy:

• Any anti-cancer therapy including chemotherapy or radiotherapy;
• Investigational therapy, including targeted small molecule agents.
• Subject has received biologic agents (e.g., monoclonal antibodies) for anti-neoplastic treatment within 30 days prior to first dose of duvelisib or venetoclax.
• Subject has received live or live attenuated vaccines within 6 weeks prior to first dose of duvelisib or venetoclax.
• Subject has received the following within 7 days prior to the first dose of duvelisib or venetoclax:

• Steroid therapy for anti-neoplastic treatment;
• Strong and Moderate CYP3A inhibitors;
• Strong and Moderate CYP3A inducers;
• Chronic immunosuppressants, other than corticosteroids given at daily dose < 20 mg prednisone equivalent for ITP or AIHA.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Infinity Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Hayslip, MD

Role: STUDY_DIRECTOR

AbbVie

Locations

Site Reference ID/Investigator# 145677

Tucson, Arizona, United States

Site Reference ID/Investigator# 147922

Chicago, Illinois, United States

Site Reference ID/Investigator# 148562

Harvey, Illinois, United States

Site Reference ID/Investigator# 148561

Goshen, Indiana, United States

Site Reference ID/Investigator# 145674

Baltimore, Maryland, United States

Site Reference ID/Investigator# 145145

Boston, Massachusetts, United States

Site Reference ID/Investigator# 148010

Detroit, Michigan, United States

Site Reference ID/Investigator# 147747

St Louis, Missouri, United States

Site Reference ID/Investigator# 145146

Lebanon, New Hampshire, United States

Site Reference ID/Investigator# 148559

Greenville, South Carolina, United States

Countries

United States

Other Identifiers

2015-003302-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M15-330

Identifier Type: -

Identifier Source: org_study_id