NCT03379051

Brief Summary

Phase I/II Study of Venetoclax or Lenalidomide in Combination with Ublituximab and Umbralisib in Subjects with Relapsed or Refractory CLL/SLL and NHL

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2018

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 20, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

March 27, 2018

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2022

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2022

Completed
Last Updated

August 22, 2022

Status Verified

August 1, 2022

Enrollment Period

4.2 years

First QC Date

December 14, 2017

Last Update Submit

August 19, 2022

Conditions

Chronic Lymphocytic LeukemiaNon-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Determine Acceptable Adverse Events That Are Related to Treatment

    12 months

Secondary Outcomes (2)

  • Overall Response and Complete Remission Rate

    12 months

  • Minimum Residual Disease (MRD)

    12 months

Study Arms (2)

Ublituximab + Umbralisib + Venetoclax

EXPERIMENTAL

Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose Venetoclax oral daily dose

Drug: VenetoclaxDrug: UmbralisibBiological: Ublituximab

Ublituximab + Umbralisib + Lenalidomide

EXPERIMENTAL

Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions; Umbralisib and Lenalidomide both administered days 1 - 21 of every 28 days

Drug: UmbralisibBiological: UblituximabDrug: Lenalidomide

Interventions

VenetoclaxDRUG

BCL-2 Inhibitor

Also known as: Venclexta
Ublituximab + Umbralisib + Venetoclax
UmbralisibDRUG

PI3K-Delta Inhibitor

Also known as: TGR-1202
Ublituximab + Umbralisib + LenalidomideUblituximab + Umbralisib + Venetoclax
UblituximabBIOLOGICAL

Glycoengineered Anti-CD20 mAb

Also known as: TG-1101
Ublituximab + Umbralisib + LenalidomideUblituximab + Umbralisib + Venetoclax
LenalidomideDRUG

Thalidomide Analog, immunomodulatory agent with antiangiogenic and antineoplastic properties

Also known as: Revlimid
Ublituximab + Umbralisib + Lenalidomide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of B-cell Chronic Lymphocytic Leukemia, or Non-Hodgkin's Lymphoma
  • Refractory to or relapsed after at least 1 prior treatment regimen
  • Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

You may not qualify if:

  • Any major surgery, chemotherapy or immunotherapy within the last 21 days
  • Known hepatitis B virus, hepatitis C virus or HIV infection
  • Known histological transformation from CLL to an aggressive lymphoma (Richter's)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

TG Therapeutics Investigational Trial Site

Chicago, Illinois, 60611, United States

Location

TG Therapeutics Investigational Trial Site

Rochester, New York, 14642, United States

Location

TG Therapeutics Investigational Trial Site

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

  • Hill BT, Ma S, Zent CS, Baran AM, Wallace DS, Advani A, Winter A, Winter J, Gordan L, Karmali R, Liesveld JL, Mulford DA, Rowland C, Bui A, Sportelli P, Miskin HP, Weiss MS, Friedberg JW, Barr PM. Response-adapted, time-limited venetoclax, umbralisib, and ublituximab for relapsed/refractory chronic lymphocytic leukemia. Blood Adv. 2024 Jan 23;8(2):378-387. doi: 10.1182/bloodadvances.2023010693.

    PMID: 37871300DERIVED

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-CellLymphoma, Non-Hodgkin

Interventions

venetoclaxumbralisibublituximabLenalidomide

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Paul Barr, MD

    Wilmot Cancer Institute - University of Rochester

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2017

First Posted

December 20, 2017

Study Start

March 27, 2018

Primary Completion

May 26, 2022

Study Completion

June 16, 2022

Last Updated

August 22, 2022

Record last verified: 2022-08

Locations

US(3)