JeRiCHO: A study to improve the treatment of relapsed or refractory Hodgkin Lymphoma with JAK-inhibitor (Ruxolitinib).

Phase 1

• Conditions: relapsed or refractoryHodgkin Lymphoma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-003369-33-DE
• Lead Sponsor: niversity of cologne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-10
• Study Completion: 2019-06-30
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Patients with relapsed or refractory HL after any polychemotherapy regimen including HDCT and ASCT who are not eligible for (another) HDCT and ASCT; age: 18 to 99 years; ECOG = 2, no major organ dysfunction (except HL related), written informed consent; Absolute Neutrophil Count (ANC) = 1.0 x 109/L, platelets = 100 x 109/L; Total bilirubin = 2 x ULN (if >2 x ULN direct bilirubin is required and should be =1.5 x ULN); ASAT = 3 x ULN (= 5 x ULN if liver involvement is present); serum creatinine = 2 x ULN; =2 weeks since last tumor therapy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 37
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 37

Exclusion Criteria

Patients who have a history of another primary malignancy = 2 years; Female patients who are pregnant or breast feeding; Patients who are using other investigational agents or who had received investigational drugs = 4 weeks prior to study drug start; Patients with a known history of HIV seropositivity, chronic active hepatitis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: • To determine the overall response rate (ORR, complete response [CR] + partial response [PR]) in patients with relapsed or refractory HL;Secondary Objective: • To determine the safety profile of ruxolitinib in patients with relapsed or refractory HL<br>• To estimate progression-free survival (PFS) and overall survival (OS)<br>• To explore biomarkers predictive of response to ruxolitinib<br>• To assess quality of life (QoL) before and during treatment<br>;Primary end point(s): • ORR after two cycles (based on PET-CT);Timepoint(s) of evaluation of this end point: After two cycles

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Adverse events during therapy<br>• ORR after two cycles (based on CT only)<br>• Treatment administration (dose reductions, duration of treatment)<br>• Progression free survival (PFS)<br>• Overall Survival (OS)<br>• Best response during therapy (based on PET-CT)<br>• Exploratory description of biomarkers<br>• QoL before therapy and at the restaging after two cycles<br>;Timepoint(s) of evaluation of this end point: During an directly after therapy.<br>Restagings are performed every three months. <br>All patients will be followed for 12 months after off-treatment visit.