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Clinical Trials/NCT02164500
NCT02164500
Completed
Phase 2

A Phase II, Open-label, Prospective, Non-randomized, Multicenter Clinical Trial With the JAK-inhibitor Ruxolitinib in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

University of Cologne1 site in 1 country12 target enrollmentOctober 2015

Overview

Phase
Phase 2
Intervention
Ruxolitinib
Conditions
Recurrent Classical Hodgkin Lymphoma
Sponsor
University of Cologne
Enrollment
12
Locations
1
Primary Endpoint
overall response rate
Status
Completed
Last Updated
6 years ago

Overview

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
Registry
clinicaltrials.gov
Start Date
October 2015
End Date
May 17, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Bastian von Tresckow

Dr.

University of Cologne

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

Arms & Interventions

Ruxolitinib

Intervention: Ruxolitinib

Outcomes

Primary Outcomes

overall response rate

Time Frame: 8 weeks

Study Sites (1)

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