NCT02757040

Brief Summary

The purpose of this study is to determine whether the combination of As2O3 and ibrutinib is synergistic in chronic lymphocytic leukemia

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2016

Status
unknown

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

April 17, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 29, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

April 29, 2016

Status Verified

April 1, 2016

Enrollment Period

1 year

First QC Date

April 17, 2016

Last Update Submit

April 27, 2016

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Keywords

chronic lymphocytic leukemiaibrutinibarsenic trioxidephosphatidylinositol 3-kinase

Outcome Measures

Primary Outcomes (1)

  • overall response rate

    2 years

Study Arms (2)

Ibrutinib combined with As2O3

EXPERIMENTAL

Ibrutinib combined with As2O3

Drug: Ibrutinib combined with As2O3

Ibrutinib

ACTIVE COMPARATOR

Ibrutinib only

Drug: ibrutinib

Interventions

Ibrutinib combined with As2O3DRUG

arsenic trioxide combined with ibrutinib in CLL

Also known as: Ibrutinib combined with arsenic trioxide
Ibrutinib combined with As2O3
ibrutinibDRUG

ibrutinib

Also known as: BTK inhibitor
Ibrutinib

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients fulfilling clinical and immune-phenotypic criteria for CLL

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Arsenic Trioxideibrutinib

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)

ArsenicalsInorganic ChemicalsOxidesOxygen Compounds

Study Officials

  • Xiao-Jun Huang, Doctor

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao-Hui Zhang, Doctor

CONTACT

861088324677zhangxh100@sina.com

Ru Feng, Doctor

CONTACT

861085136381frbld@sina.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2016

First Posted

April 29, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

April 29, 2016

Record last verified: 2016-04