Everolimus in Combination With DHAP in Patients With Rela... | NCT01453504

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

NCT01453504

Sponsor

University of Cologne

Status

Completed

Last Update Posted

Nov 8, 2019Actual

Enrollment

73Actual

Phase

Phase 1Phase 2

Conditions

Hodgkin Lymphoma

Interventions

DHAP
Everolimus

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Mar 2019Actual

Completion Date

Mar 2019Actual

First Submitted Date

Oct 17, 2011

First Submission Date that Met QC Criteria

Oct 17, 2011

First Posted Date

Oct 18, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 7, 2019

Last Update Posted Date

Nov 8, 2019Actual

Description Module

Brief Summary

The purpose of this trial is

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

73Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ever-DHAP	Active Comparator	Combination of Everolimus and DHAP	Drug: DHAP Drug: Everolimus
Placebo-DHAP	Placebo Comparator		Drug: DHAP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DHAP	Drug	Dexamethasone, Cytarabine, Cisplatin	Ever-DHAP Placebo-DHAP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Adverse event rate	Phase I secondary outcome measure	4 weeks
Tumor status (assessed by CT) after chemotherapy	Phase II secondary outcome measure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Borchmann, Prof.	University of Cologne, German Hodgkin Study Group	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
1st Dept. of Medicine, Cologne University Hospital		Cologne			Germany

Label	URL
Homepage GHSG	View source

Condition Browse Module

MeSH Terms

ID	Term
D006689	Hodgkin Disease

Ancestor Terms

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068338	Everolimus

Ancestor Terms

ID	Term
D020123	Sirolimus
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided