NCT01453504

Brief Summary

The purpose of this trial is

  1. 1.to determine the recommended dose of everolimus for a subsequent Phase II trial
  2. 2.to determine the efficacy of everolimus plus DHAP

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2012

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 18, 2011

Completed
10 months until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

November 8, 2019

Status Verified

November 1, 2019

Enrollment Period

6.6 years

First QC Date

October 17, 2011

Last Update Submit

November 7, 2019

Conditions

Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (2)

  • Dose Limiting Toxicity Rate (DLT)

    Phase I primary outcome measure

    4 weeks

  • Complete Remission Rate (CR)

    Phase II primary outcome measure

    4 weeks

Secondary Outcomes (3)

  • Adverse event rate

    4 weeks

  • Tumor status (assessed by CT) after chemotherapy

    4 weeks

  • Tumor status (assessed by PET) after chemotherapy

    4 weeks

Study Arms (2)

Ever-DHAP

ACTIVE COMPARATOR

Combination of Everolimus and DHAP

Drug: DHAPDrug: Everolimus

Placebo-DHAP

PLACEBO COMPARATOR
Drug: DHAP

Interventions

DHAPDRUG

Dexamethasone, Cytarabine, Cisplatin

Ever-DHAPPlacebo-DHAP
EverolimusDRUG
Ever-DHAP

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1st Dept. of Medicine, Cologne University Hospital

Cologne, Germany

Location

Related Links

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Everolimus

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • Peter Borchmann, Prof.

    University of Cologne, German Hodgkin Study Group

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

October 17, 2011

First Posted

October 18, 2011

Study Start

August 1, 2012

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

November 8, 2019

Record last verified: 2019-11

Locations

DE(1)