NCT02164500

Brief Summary

The Purpose of this trial is:

  • to determine the overall response rate (ORR, complete response \[CR\] + partial response \[PR\]) in patients with relapsed or refractory HL
  • to determine the safety profile of ruxolitinib in patients with relapsed or refractory HL

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

June 12, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 16, 2014

Completed
1.3 years until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2019

Completed
Last Updated

April 6, 2020

Status Verified

April 1, 2020

Enrollment Period

3.6 years

First QC Date

June 12, 2014

Last Update Submit

April 3, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • overall response rate

    8 weeks

Study Arms (1)

Ruxolitinib

EXPERIMENTAL
Drug: Ruxolitinib

Interventions

Ruxolitinib

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • relapsed or refractory HL
  • ECOG \<= 2,
  • no major organ dysfunction
  • written informed consent

You may not qualify if:

  • history of another primary malignancy ≤ 2 years
  • female patients who are pregnant or breast feeding
  • patients with a known history of HIV seropositivity
  • chronic active hepatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1st Dept. of Medicine, Cologne University Hospital

Cologne, 50924, Germany

Location

Related Links

MeSH Terms

Interventions

ruxolitinib

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

June 12, 2014

First Posted

June 16, 2014

Study Start

October 1, 2015

Primary Completion

May 17, 2019

Study Completion

May 17, 2019

Last Updated

April 6, 2020

Record last verified: 2020-04

Locations