## Protocol Section
### Identification Module
**NCT ID:** NCT01056679

**Acronym:** AVD-Rev

**Brief Title:** Adriamycin, Vinblastine, DTIC and Revlimid in Elderly Hodgkin Lymphoma Patients

**Official Title:** Phase I Trial of AVD Plus Lenalidomide (Revlimid) in Elderly Intermediate or Advanced Stage Hodgkin Lymphoma Patients

#### Organization Study ID Info
**ID:** AVD-Rev
#### Organization
**Class:** OTHER
**Full Name:** University of Cologne
### Status Module
#### Completion Date
**Date:** 2016-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-03-22

**Type:** ACTUAL

**Last Update Submit Date:** 2018-03-21

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2014-04

**Type:** ACTUAL

#### Start Date
**Date:** 2010-04

**Status Verified Date:** 2018-03

#### Study First Post Date
**Date:** 2010-01-26
**Type:** ESTIMATED
**Study First Submit Date:** 2009-09-08
**Study First Submit QC Date:** 2010-01-25
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Cologne

#### Responsible Party

**Investigator Affiliation:** University of Cologne

**Investigator Full Name:** Prof. Dr. Andreas Engert

**Investigator Title:** Prof.

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### 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.

### Conditions Module

**Conditions:**

- Hodgkin Lymphoma

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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

**Intervention Names:**

- Drug: Doxorubicine

- Drug: DTIC

- Drug: Lenalidomide

- Drug: Vinblastine

**Label:** AVD-Rev

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- AVD-Rev

**Description:** 50mg/m2 day 1 + 15

**Name:** Doxorubicine

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- AVD-Rev

**Description:** 375mg/m2 day 1 + 15

**Name:** DTIC

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- AVD-Rev

**Description:** day 1 - 21

**Name:** Lenalidomide

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- AVD-Rev

**Description:** 6mg/m2 day 1 + 15

**Name:** Vinblastine

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Dose limiting toxicities (DLT)

#### Secondary Outcomes

**Measure:** Overall response rate (ORR)

**Measure:** Progression free survival (PFS)

**Time Frame:** 2 years

### 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

**Maximum Age:** 75 Years

**Minimum Age:** 60 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Cologne

**Country:** Germany

**Facility:** 1st Dept. of Medicine, Cologne University Hospital

**State:** NRW

**Zip:** 50924

#### Overall Officials

**Official 1:**

**Affiliation:** University of Cologne

**Name:** Andreas Engert, Prof.

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### See Also Links

**Label:** Related Info

**URL:** http://www.ghsg.org

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000008232

- Term: Lymphoproliferative Disorders

- ID: D000008206

- Term: Lymphatic Diseases

- ID: D000007160

- Term: Immunoproliferative Disorders

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M11220

- Name: Lymphoma

- Relevance: HIGH

- As Found: Lymphoma

- ID: M9751

- Name: Hodgkin Disease

- Relevance: HIGH

- As Found: Hodgkin Lymphoma

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M11225

- Name: Lymphoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M11203

- Name: Lymphatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10206

- Name: Immunoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T3543

- Name: Lymphosarcoma

- Relevance: HIGH

- As Found: Lymphoma

- ID: T2817

- Name: Hodgkin Lymphoma

- Relevance: HIGH

- As Found: Hodgkin Lymphoma

### Condition Browse Module - Meshes

- ID: D000008223

- Term: Lymphoma

- ID: D000006689

- Term: Hodgkin Disease

### Intervention Browse Module - Ancestors

- ID: D000000903

- Term: Antibiotics, Antineoplastic

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000059005

- Term: Topoisomerase II Inhibitors

- ID: D000059003

- Term: Topoisomerase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000020533

- Term: Angiogenesis Inhibitors

- ID: D000043924

- Term: Angiogenesis Modulating Agents

- ID: D000006133

- Term: Growth Substances

- ID: D000006131

- Term: Growth Inhibitors

- ID: D000000972

- Term: Antineoplastic Agents, Phytogenic

- ID: D000050257

- Term: Tubulin Modulators

- ID: D000050256

- Term: Antimitotic Agents

- ID: D000050258

- Term: Mitosis Modulators

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infe

- Name: Anti-Infective Agents

### Intervention Browse Module - Browse Leaves

- ID: M7492

- Name: Doxorubicin

- Relevance: HIGH

- As Found: Women

- ID: M227339

- Name: Liposomal doxorubicin

- Relevance: LOW

- As Found: Unknown

- ID: M1725

- Name: Lenalidomide

- Relevance: HIGH

- As Found: Respiratory

- ID: M17492

- Name: Vinblastine

- Relevance: HIGH

- As Found: Issues

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4224

- Name: Antibiotics, Antitubercular

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

- ID: M22318

- Name: Angiogenesis Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M9231

- Name: Growth Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M26197

- Name: Tubulin Modulators

- Relevance: LOW

- As Found: Unknown

- ID: M26196

- Name: Antimitotic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000004317

- Term: Doxorubicin

- ID: D000077269

- Term: Lenalidomide

- ID: D000014747

- Term: Vinblastine

### Misc Info Module

- Version Holder: 2024-05-24
