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

NCT01056679 | Completed Phase 1 DMC

• 1 other identifier: AVD-Rev
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• Dose limiting toxicities (DLT)

Secondary Outcomes (2)

• Overall response rate (ORR)

• Progression free survival (PFS)

  2 years

Study Arms (1)

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

Doxorubicine DRUG

50mg/m2 day 1 + 15

AVD-Rev

DTIC DRUG

375mg/m2 day 1 + 15

AVD-Rev

Lenalidomide DRUG

day 1 - 21

AVD-Rev

Vinblastine DRUG

6mg/m2 day 1 + 15

AVD-Rev

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

1st Dept. of Medicine, Cologne University Hospital

Cologne, North Rhine-Westphalia, 50924, Germany

Location

Related Links

• Related Info

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Doxorubicin; Dacarbazine; Lenalidomide; Vinblastine

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines

Study Officials

• Andreas Engert, Prof.

  University of Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: September 8, 2009
• First Posted: January 26, 2010
• Study Start: April 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: February 1, 2016
• Last Updated: March 22, 2018

Record last verified: 2018-03

Locations

DE (1)