NCT02626884

Brief Summary

The purpose of this trial is to determine

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2016

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

December 2, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 10, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

4 years

First QC Date

December 2, 2015

Last Update Submit

April 6, 2021

Conditions

Nodular Lymphocyte-Predominant Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Response Rate

    after 6 cycles (each cycle is 21 days) of Ibrutinib

Secondary Outcomes (1)

  • Remission status

    Remission status after six, twelve and 20 21-day cycles of ibrutinib

Study Arms (1)

Ibrutinib

EXPERIMENTAL

All patient receive ibrutinib at a dose of 560 mg/d for up to 20 21-day cycles

Drug: Ibrutinib

Interventions

IbrutinibDRUG
Ibrutinib

Eligibility Criteria

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

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1st Department of Medicine, Cologne University Hospital

Cologne, Germany

Location

MeSH Terms

Conditions

Hodgkin Disease

Interventions

ibrutinib

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Andreas Engert, Prof.

    University Hospital of Cologne

    PRINCIPAL INVESTIGATOR

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
Prof.

Study Record Dates

First Submitted

December 2, 2015

First Posted

December 10, 2015

Study Start

August 1, 2016

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

April 8, 2021

Record last verified: 2021-04

Locations

DE(1)