Study to Assess the Efficacy and Safety of Ublituximab + Umbralisib With or Without Bendamustine and Umbralisib Alone in Patients With Previously Treated Non-Hodgkins Lymphoma

Conditions

Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, Small Lymphocytic Lymphoma

Keywords

DLBCL, FL, MZL, MCL, SLL, Non-Hodgkin's Lymphoma

Brief summary

Unity NHL - A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + Umbralisib with or without Bendamustine and Umbralisib alone in Patients with Previously Treated Non-Hodgkin's Lymphoma

Detailed description

The purpose of this study is to evaluate the efficacy and safety of umbralisib monotherapy and the umbralisib + ublituximab (U2) combination in aggressive and indolent lymphomas and to also explore the U2 regimen in combination with bendamustine in the treatment of NHL (FL, SLL, MZL, DLBCL and MCL).

Alfaifi A, Bahashwan S, Alsaadi M, Ageel AH, Ahmed HH, Fatima K, Malhan H, Qadri I, Almehdar H.

2024-11-124 citations

10.1155/2024/5948170

The Combination of Umbralisib Plus Ublituximab Is Active in Patients with Relapsed or Refractory Marginal Zone Lymphoma (MZL): Results from the Phase 2 Global Unity-NHL Trial

Julio C. Chávez, Neta Goldschmidt, Felipe Samaniego, Tomasz Wróbel, Federica Cavallo et al. (15 authors)

Blood2021-11-056 citations

10.1182/blood-2021-147425

Umbralisib, the Once Daily Dual Inhibitor of PI3Kδ and Casein Kinase-1ε Demonstrates Clinical Activity in Patients with Relapsed or Refractory Indolent Non-Hodgkin Lymphoma: Results from the Phase 2 Global Unity-NHL Trial

Pier Luigi Zinzani, Felipe Samaniego, Wojciech Jurczak, Nilanjan Ghosh, Enrico Derenzini et al. (28 authors)

Blood2020-11-0510 citations

10.1182/blood-2020-134851

Antibodies to watch in 2020.

Kaplon H, Muralidharan M, Schneider Z, Reichert JM.

2020-01-01328 citations

10.1080/19420862.2019.1703531

Umbralisib monotherapy demonstrates efficacy and safety in patients with relapsed/refractory marginal zone lymphoma: A multicenter, open label, registration directed phase II study.

Nathan Fowler, Felipe Samaniego, Wojciech Jurczak, Ewa Lech‐Marańda, Nilanjan Ghosh et al. (20 authors)

Journal of Clinical Oncology2019-05-2013 citations

10.1200/jco.2019.37.15_suppl.7506

Interventions

BIOLOGICALUblituximab

DRUGUmbralisib

BIOLOGICALBendamustine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Diagnosis of Non-Hodgkin's Lymphoma including Follicular, Mantle Cell Lymphoma and Marginal Zone Lymphoma * Relapsed or refractory to prior standard therapy and subjects who are not candidates for high-dose therapy or autologous stem cell transplant * MCL subjects with one or more lines of therapy including at least one BTK inhibitor (ibrutinib, acalabrutinib or zanibrutinib only)

Exclusion criteria

* Any major surgery, chemotherapy or immunotherapy within the last 21 days * Evidence of hepatitis B virus, hepatitis C virus or known HIV infection * Autologous hematologic stem cell transplant within 6 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded * Prior therapy with a PI3K delta inhibitor

Design outcomes

Primary

Measure	Time frame
Overall Response Rate	Every 8-12 weeks, up to 2 years

Secondary

Measure	Time frame
Progression-Free Survival	From date of randomization until the date of first documented progression, assessed up through 2 years

Countries

Australia, Israel, Italy, Poland, Slovakia, South Korea, Spain, United Kingdom, United States

Outcome results

None listed