Everolimus in Combination With DHAP in Patients With Relapsed or Refractory Hodgkin Lymphoma

Phase 1

Completed

• Conditions: Hodgkin Lymphoma
• Interventions: Drug: DHAP; Drug: Everolimus

• Registration Number: NCT01453504
• Lead Sponsor: University of Cologne

Brief Summary

The purpose of this trial is

1. to determine the recommended dose of everolimus for a subsequent Phase II trial

2. to determine the efficacy of everolimus plus DHAP

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-17
• Study First Submitted QC: 2011-10-17
• Study First Posted: 2011-10-18
• Study Start: 2012-08
• Primary Completion: 2019-03
• Study Completion: 2019-03
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-07
• Last Update Posted: 2019-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

• relapsed or refractory Hodgkin Lymphoma
• age 18-60
• histology confirmed relapse

Exclusion Criteria

• previous therapy with mTOR inhibitor
• current CNS involvement
• other primary malignant disease within the last 3 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ever-DHAP	Everolimus	Combination of Everolimus and DHAP
Ever-DHAP	DHAP	Combination of Everolimus and DHAP
Placebo-DHAP	DHAP	-

Primary Outcome Measures

Name	Time	Method
Complete Remission Rate (CR)	4 weeks	Phase II primary outcome measure
Dose Limiting Toxicity Rate (DLT)	4 weeks	Phase I primary outcome measure

Secondary Outcome Measures

Name	Time	Method
Adverse event rate	4 weeks	Phase I secondary outcome measure
Tumor status (assessed by CT) after chemotherapy	4 weeks	Phase II secondary outcome measure
Tumor status (assessed by PET) after chemotherapy	4 weeks	Phase II secondary outcome measure

Trial Locations

Locations (1)

1st Dept. of Medicine, Cologne University Hospital; 🇩🇪 Cologne, Germany