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NCT01453504 Clinical Trial

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

Hodgkin Lymphoma Clinical Trial

— HD-R3i  

Official title:
A Prospective, Randomized, Placebo-controlled, Multicenter, International Phase I/II Trial of RAD001 (Everolimus) in Combination With DHAP as Induction Therapy in Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01453504
Other study ID # HD-R3i
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date August 2012
Est. completion date March 2019

Study information
Verified date November 2019
Source University of Cologne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 73
Est. completion date March 2019
Est. primary completion date March 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• DHAP
Dexamethasone, Cytarabine, Cisplatin
• Everolimus

Locations
Country Name City State
Germany 1st Dept. of Medicine, Cologne University Hospital Cologne

Sponsors (1)
Lead Sponsor Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dose Limiting Toxicity Rate (DLT) Phase I primary outcome measure 4 weeks
Primary Complete Remission Rate (CR) Phase II primary outcome measure 4 weeks
Secondary Adverse event rate Phase I secondary outcome measure 4 weeks
Secondary Tumor status (assessed by CT) after chemotherapy Phase II secondary outcome measure 4 weeks
Secondary Tumor status (assessed by PET) after chemotherapy Phase II secondary outcome measure 4 weeks
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