JAK-inhibition in Recurrent Classical Hodgkin Lymphoma | NCT02164500

Studies
JAK-inhibition in Recurrent Classical Hodgkin Lymphoma

NCT02164500

Sponsor

University of Cologne

Status

Completed

Last Update Posted

Apr 6, 2020Actual

Enrollment

12Actual

Phase

Phase 2

Conditions

Recurrent Classical Hodgkin Lymphoma

Interventions

Ruxolitinib

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

May 17, 2019Actual

Completion Date

May 17, 2019Actual

First Submitted Date

Jun 12, 2014

First Submission Date that Met QC Criteria

Jun 12, 2014

First Posted Date

Jun 16, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2020

Last Update Posted Date

Apr 6, 2020Actual

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Label	Type	Description	Intervention Names
Ruxolitinib	Experimental		Drug: Ruxolitinib

Name	Type	Description	Arm Group Labels	Other Names
Ruxolitinib	Drug		Ruxolitinib

Measure	Description	Time Frame
overall response rate		8 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
1st Dept. of Medicine, Cologne University Hospital		Cologne		50924	Germany

Label	URL
Homepage GHSG	View source

Intervention Browse Module

MeSH Terms

ID	Term
C540383	ruxolitinib

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided