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)
Phase 1/Phase 2
18 Years
60 Years
18 Years
60 Years
Open (Enrolling)
Both
Hodgkin Lymphoma
Both
Hodgkin Lymphoma
Trial Information
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)
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
DLT rate
Outcome Description:
Phase I primary outcome measure
Outcome Time Frame:
4 weeks
Safety Issue:
Yes
Principal Investigator
Peter Borchmann, Prof.
Investigator Role:
Study Chair
Investigator Affiliation:
University of Cologne, German Hodgkin Study Group
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
HD-R3i
NCT ID:
NCT01453504
Start Date:
August 2012
Completion Date:
August 2016
Related Keywords:
- Hodgkin Lymphoma
- Hodgkin Disease
- Lymphoma
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