NCT02100852

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in combination with obinutuzumab (Gazyva) and chlorambucil in patients with chronic lymphocytic leukemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2014

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

March 12, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2014

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

October 2, 2019

Status Verified

October 1, 2019

Enrollment Period

3.6 years

First QC Date

March 27, 2014

Last Update Submit

October 1, 2019

Conditions

Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose acceptable for participants

    To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities

    28 days (1 cycle of therapy)

Secondary Outcomes (1)

  • Overall Response Rate

    Up to 1 year

Study Arms (1)

TGR-1202 + Obinutuzumab + Chlorambucil

EXPERIMENTAL

TGR-1202 is an oral daily dose with obinutuzumab at a fixed IV infusion and chlorambucil as an oral dose on specified days.

Drug: TGR-1202 + Obinutuzumab + Chlorambucil

Interventions

TGR-1202 + Obinutuzumab + ChlorambucilDRUG

TGR-1202: Oral dose Obinutuzumab: IV infusion Chlorambucil: Oral dose

Also known as: Obinutuzumab: Gazyva, Chlorambucil: Leukeran
TGR-1202 + Obinutuzumab + Chlorambucil

Eligibility Criteria

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

You may qualify if:

  • Confirmed Chronic Lymphocytic Leukemia (CLL)
  • Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
  • Ability to swallow oral medication

You may not qualify if:

  • Known hepatitis B virus, hepatitis C virus or HIV infection
  • Primary central nervous system lymphoma or known intracranial involvement
  • Autologous hematologic stem cell transplant within 3 months of study entry or Allogeneic hematologic stem cell transplant within 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

TG Therapeutics Investigational Trial Site

Huntsville, Alabama, 35805, United States

Location

TG Therapeutics Investigational Trial Site

Memphis, Tennessee, 38119, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

umbralisibobinutuzumabChlorambucil

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 Symptoms

Intervention Hierarchy (Ancestors)

Nitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic Chemicals

Study Design

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

Study Record Dates

First Submitted

March 27, 2014

First Posted

April 1, 2014

Study Start

March 12, 2014

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

October 2, 2019

Record last verified: 2019-10

Locations

US(2)