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



Status:Recruiting
Conditions:Blood Cancer, Lymphoma, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:4/21/2016
Start Date:April 2016
End Date:January 2020
Contact:Mary M. Kuriakose, MS
Email:mary.m.kuriakose@abbvie.com
Phone:847-937-1662

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A Phase 1b/2 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

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.


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.
We found this trial at
7
sites
St. Louis, Missouri 63104
Principal Investigator: Site Reference ID/Investigator# 147747, MD
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St. Louis, MO
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Chicago, Illinois
Principal Investigator: Site Reference ID/Investigator# 147922, MD/PhD
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Chicago, IL
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Detroit, Michigan
Principal Investigator: Site Reference ID/Investigator# 148010, MD
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Detroit, MI
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Goshen, Indiana 46526
Principal Investigator: Site Reference ID/Investigator# 148561, MD
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Goshen, IN
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Greenville, South Carolina 29605
Principal Investigator: Site Reference ID/Investigator# 148559, MD
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Greenville, SC
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Harvey, Illinois 60426
Principal Investigator: Site Reference ID/Investigator# 148562, MD
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Harvey, IL
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Tucson, Arizona 85724
Principal Investigator: Site Reference ID/Investigator# 145677, MD
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Tucson, AZ
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