Adriamycin, Vinblastine, DTIC and Revlimid in Elderly Hod... | NCT01056679

Studies
Adriamycin, Vinblastine, DTIC and Revlimid in Elderly Hodgkin Lymphoma Patients

NCT01056679

Sponsor

University of Cologne

Status

Completed

Last Update Posted

Mar 22, 2018Actual

Enrollment

30Estimated

Phase

Phase 1

Conditions

Hodgkin Lymphoma

Interventions

Doxorubicine
DTIC
Lenalidomide
Vinblastine

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

Mar 2018

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

Apr 2010

Primary Completion Date

Apr 2014Actual

Completion Date

Feb 2016Actual

First Submitted Date

Sep 8, 2009

First Submission Date that Met QC Criteria

Jan 25, 2010

First Posted Date

Jan 26, 2010Estimated

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

Mar 21, 2018

Last Update Posted Date

Mar 22, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine within the scope of the trial what the maximum tolerated dose (MTD) of lenalidomide in combination with AVD should be.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AVD-Rev	Experimental	Patients with intermediate stage HL receive 4 cycles of AVD-Rev followed by 30 Gy IF-RT Patientes with advanced stage HL receive 6 to 8 cycles of AVD-Rev followed by 30 GY IF-RT depending on the FDG-PET results	Drug: Doxorubicine Drug: DTIC Drug: Lenalidomide Drug: Vinblastine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Doxorubicine	Drug	50mg/m2 day 1 + 15	AVD-Rev
DTIC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dose limiting toxicities (DLT)

Secondary Outcomes

Measure	Description	Time Frame
Overall response rate (ORR)
Progression free survival (PFS)		2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hodgkin Lymphoma, intermediate or advanced stage
Age >60 and <75 years
ECOG 2 or better
No major organ dysfunction
Ability to take aspirin or LMW Heparin

Exclusion Criteria:

HL as composite lymphoma
Prior use of lenalidomide
Prior use of chemo- or radiotherapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andreas Engert, Prof.	University of Cologne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
1st Dept. of Medicine, Cologne University Hospital		Cologne	North Rhine-Westphalia	50924	Germany

Label	URL
Related Info	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
D004317	Doxorubicin
D003606	Dacarbazine
D000077269	Lenalidomide
D014747	Vinblastine

Ancestor Terms

ID	Term
D003630	Daunorubicin
D018943	Anthracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons

Browse Leaves

Not provided

Browse Branches

Not provided