Ublituximab in Combination With TGR-1202 +/- Ibrutinib or Bendamustine in Patients With B-cell Malignancies

Conditions

Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma

Brief summary

The purpose of this study is to evaluate the safety and effectiveness of Ublituximab in combination with TGR-1202, with or without ibrutinib or bendamustine, in patients with advanced hematologic malignancies

Lunning M, Vose J, Nastoupil L, Fowler N, Burger JA, Wierda WG, Schreeder MT, Siddiqi T, Flowers CR, Cohen JB, Sportelli P, Miskin HP, Weiss MS, O'Brien S.

2019-11-0157 citations

10.1182/blood.2019002118

Tolerability and activity of ublituximab, umbralisib, and ibrutinib in patients with chronic lymphocytic leukaemia and non-Hodgkin lymphoma: a phase 1 dose escalation and expansion trial.

Nastoupil LJ, Lunning MA, Vose JM, Schreeder MT, Siddiqi T, Flowers CR, Cohen JB, Burger JA, Wierda WG, O'Brien S, Sportelli P, Miskin HP, Purdom MA, Weiss MS, Fowler NH.

2019-02-0148 citations

10.1016/s2352-3026(18)30216-3

Tolerability and activity of chemo-free triplet combination of TGR-1202, ublituximab, and ibrutinib in patients with advanced CLL and NHL.

Loretta J. Nastoupil, Matthew A. Lunning, Julie M. Vose, Marshall T. Schreeder, Tanya Siddiqi et al. (15 authors)

Journal of Clinical Oncology2017-05-204 citations

10.1200/jco.2017.35.15_suppl.7511

Long-term follow-up of the PI3Kδ inhibitor TGR-1202 to demonstrate a differentiated safety profile and high response rates in CLL and NHL: Integrated-analysis of TGR-1202 monotherapy and combined with ublituximab.

Howard A. Burris, Ian W. Flinn, Matthew A. Lunning, Julie M. Vose, Nathan Fowler et al. (20 authors)

Journal of Clinical Oncology2016-05-2020 citations

10.1200/jco.2016.34.15_suppl.7512

Safety and activity of the chemotherapy-free triplet of ublituximab, TGR-1202, and ibrutinib in relapsed B-cell malignancies.

Nathan Fowler, Loretta J. Nastoupil, Matthew A. Lunning, Julie M. Vose, Tanya Siddiqi et al. (20 authors)

Journal of Clinical Oncology2015-05-2011 citations

10.1200/jco.2015.33.15_suppl.8501

Ublituximab plus TGR-1202 activity and safety profile in relapsed/refractory B-cell NHL and high-risk CLL.

Matthew A. Lunning, Julie M. Vose, Nathan Fowler, Loretta J. Nastoupil, Marshall T. Schreeder et al. (19 authors)

Journal of Clinical Oncology2015-05-206 citations

10.1200/jco.2015.33.15_suppl.8548

Interventions

DRUGUblituximab + TGR-1202

Ublituximab IV infusion TGR-1202 oral daily dose

DRUGUblituximab + TGR-1202 + ibrutinib

Ublituximab IV infusion TGR-1202 oral daily dose Ibrutinib oral daily dose

DRUGUblituximab + TGR-1202 + bendamustine

Ublituximab IV infusion TGR-1202 oral daily dose Bendamustine IV infusion

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Confirmed B-cell non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and other B-cell lymphoproliferative disorders as approved by the Medical Monitor or Study Chair * Refractory to or relapsed after at least 1 prior treatment regimen * Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion criteria

* Any major surgery, chemotherapy or immunotherapy within the last 21 days * Known hepatitis B virus, hepatitis C virus or HIV infection * Autologous hematologic stem cell transplant within 3 months of study entry or Allogeneic hematologic stem cell transplant within 12 months * Primary central nervous system lymphoma or known intracranial involvement

Design outcomes

Primary

Measure	Time frame	Description
Maximum Tolerated Dose acceptable for participants	28 days (1 cycle of therapy)	To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities

Secondary

Measure	Time frame	Description
Overall Response Rate	Up to 1 year	To assess the overall response rate (ORR) in patients with hematologic malignancies treated with Ublituximab in combination with TGR-1202

Countries

United States

Outcome results

None listed