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

University of Cologne73 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hodgkin Lymphoma

Interventions

DHAPDRUG

Dexamethasone, Cytarabine, Cisplatin

EverolimusDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

1st Dept. of Medicine, Cologne University Hospital

Cologne, Germany

Outcomes

Primary Outcomes

Dose Limiting Toxicity Rate (DLT)

Phase I primary outcome measure

Time frame: 4 weeks

Complete Remission Rate (CR)

Phase II primary outcome measure

Time frame: 4 weeks

Secondary Outcomes

Adverse event rate

Phase I secondary outcome measure

Time frame: 4 weeks

Tumor status (assessed by CT) after chemotherapy

Phase II secondary outcome measure

Time frame: 4 weeks

Tumor status (assessed by PET) after chemotherapy

Phase II secondary outcome measure

Time frame: 4 weeks

Data from ClinicalTrials.gov

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