Everolimus in Combination With DHAP in Patients With Relapsed or Refractory Hodgkin Lymphoma (HD-R3i)

University of Cologne

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hodgkin Lymphoma

Treatments: Drug: Everolimus; Drug: DHAP

Study type: Interventional

Funder types: Other

Identifiers

NCT01453504

HD-R3i

Details and patient eligibility

About

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

Enrollment: 73 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

73 participants in 2 patient groups, including a placebo group

Ever-DHAP

Active Comparator group

Description:

Combination of Everolimus and DHAP

Treatment:

Drug: DHAP

Drug: Everolimus

Placebo-DHAP

Placebo Comparator group

Treatment:

Drug: DHAP