Ibrutinib in Relapsed Nodular Lymphocyte-predominant Hodg... | NCT02626884

Studies
Ibrutinib in Relapsed Nodular Lymphocyte-predominant Hodgkin Lymphoma (NLPHL)

NCT02626884

Sponsor

University of Cologne

Status

Completed

Last Update Posted

Apr 8, 2021Actual

Enrollment

14Actual

Phase

Phase 2

Conditions

Nodular Lymphocyte-Predominant Hodgkin's Lymphoma

Interventions

Ibrutinib

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

ID	Type	Description	Link
2015-003128-30	EudraCT Number

Status Module

Record Verification Date

Apr 2021

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

Aug 2016

Primary Completion Date

Aug 2020Actual

Completion Date

Aug 2020Actual

First Submitted Date

Dec 2, 2015

First Submission Date that Met QC Criteria

Dec 7, 2015

First Posted Date

Dec 10, 2015Estimated

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 6, 2021

Last Update Posted Date

Apr 8, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this trial is to determine

Disease stabilization/response rate after six 21-day cycles of ibrutinib
Remission status after six, twelve and 20 21-day cycles of ibrutinib

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

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ibrutinib	Experimental	All patient receive ibrutinib at a dose of 560 mg/d for up to 20 21-day cycles	Drug: Ibrutinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ibrutinib	Drug		Ibrutinib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Response Rate		after 6 cycles (each cycle is 21 days) of Ibrutinib

Secondary Outcomes

Measure	Description	Time Frame
Remission status		Remission status after six, twelve and 20 21-day cycles of ibrutinib

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria (key criteria):

Histologically proven relapsed nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL) as confirmed by expert review
Age at entry 18-99 years
ECOG status 0-2
Absolute leukocyte count > 2.500/mm3
Absolute neutrophil count > 1.000/mm3 independent of growth factor support
Platelet count > 100.000/mm3 or > 50.000/mm3 in case of bone marrow involvement independent of transfusion support in either situation
GPT and GOT ≤ 3 x upper limit of normal (ULN)

Exclusion Criteria (key criteria):

Classical HL (cHL) or composite lymphoma
Known central nervous lymphoma
Prior Btk inhibitor treatment
Life expectancy < 3 months
Major surgery within 4 weeks of study inclusion
History of stroke or intracranial hemorrhage within 6 months prior to the first study drug
Current anticoagulation with warfarin or equivalent vitamin K antagonists

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

Name	Affiliation	Role
Andreas Engert, Prof.	University Hospital of Cologne	Principal Investigator

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D006689	Hodgkin Disease

Ancestor Terms

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C551803	ibrutinib

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided