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

NCT ID: NCT01056679

Last Updated: 2018-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2016-02-29

Brief Summary

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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

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Conditions

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Hodgkin Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AVD-Rev

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

Group Type EXPERIMENTAL

Doxorubicine

Intervention Type DRUG

50mg/m2 day 1 + 15

DTIC

Intervention Type DRUG

375mg/m2 day 1 + 15

Lenalidomide

Intervention Type DRUG

day 1 - 21

Vinblastine

Intervention Type DRUG

6mg/m2 day 1 + 15

Interventions

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Doxorubicine

50mg/m2 day 1 + 15

Intervention Type DRUG

DTIC

375mg/m2 day 1 + 15

Intervention Type DRUG

Lenalidomide

day 1 - 21

Intervention Type DRUG

Vinblastine

6mg/m2 day 1 + 15

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cologne

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Andreas Engert

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Engert, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Cologne

Locations

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1st Dept. of Medicine, Cologne University Hospital

Cologne, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Related Links

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Other Identifiers

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AVD-Rev

Identifier Type: -

Identifier Source: org_study_id

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