Phase II R-ABVD Versus ABVD for Advanced Stage Classical Hodgkin Lymphoma - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	Genentech
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00654732

Purpose

The goal of this clinical research study is to compare the effectiveness of receiving Adriamycin (doxorubicin hydrochloride), bleomycin, vinblastine, and dacarbazine (ABVD) therapy alone to receiving ABVD with rituximab.

Condition	Intervention	Phase
Hodgkin Lymphoma	Drug: Rituximab Drug: Adriamycin Drug: Bleomycin Drug: Vinblastine Drug: Dacarbazine	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized Phase II Study of Rituximab With ABVD Versus Standard ABVD for Patients With Advanced-Stage Classical Hodgkin Lymphoma With Poor Risk Features (IPS Score > 2)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Hodgkin Disease Lymphoma

Drug Information available for: Bleomycin Doxorubicin Doxorubicin hydrochloride Rituximab Vinblastine sulfate Vinblastine Dacarbazine Bleomycin sulfate

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Number of Patients with Event-Free Survival (EFS) [ Time Frame: Baseline to 3 Years ] [ Designated as safety issue: No ]
Efficacy of combination regimen of rituximab and ABVD chemotherapy (R-ABVD) and ABVD alone measured as event-free survival (EFS).

Estimated Enrollment:	120
Study Start Date:	March 2008
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: R-ABVD Therapy	Drug: Rituximab 375 mg/m^2 IV Weekly Over 7 Hours On Days 1, 8, 15, 22. Other Name: Rituxan Drug: Adriamycin 25 mg/m^2 IV Over 1 Hour On Day 1 and 15. Other Names: Doxorubicin Hydrochloride Adriamycin PFS® Adriamycin RDF™ Drug: Bleomycin 10 U/m^2 IV Over 1 Hour On Day 1 and 15. Other Names: Bleomycin sulfate Blenoxane® BLM Drug: Vinblastine 6 mg/m^2 IV Over 1 Hour On Day 1 and 15. Other Name: Velban Drug: Dacarbazine 375 mg/m^2 IV Over 1 Hour On Day 1 and 15. Other Names: DTIC DTIC-Dome®
Active Comparator: ABVD Therapy	Drug: Adriamycin 25 mg/m^2 IV Over 1 Hour On Day 1 and 15. Other Names: Doxorubicin Hydrochloride Adriamycin PFS® Adriamycin RDF™ Drug: Bleomycin 10 U/m^2 IV Over 1 Hour On Day 1 and 15. Other Names: Bleomycin sulfate Blenoxane® BLM Drug: Vinblastine 6 mg/m^2 IV Over 1 Hour On Day 1 and 15. Other Name: Velban Drug: Dacarbazine 375 mg/m^2 IV Over 1 Hour On Day 1 and 15. Other Names: DTIC DTIC-Dome®

Arms

Assigned Interventions

Experimental: R-ABVD Therapy

Drug: Rituximab

375 mg/m^2 IV Weekly Over 7 Hours On Days 1, 8, 15, 22.

Other Name: Rituxan

Drug: Adriamycin

25 mg/m^2 IV Over 1 Hour On Day 1 and 15.

Other Names:

Doxorubicin Hydrochloride
Adriamycin PFS®
Adriamycin RDF™

Drug: Bleomycin

10 U/m^2 IV Over 1 Hour On Day 1 and 15.

Other Names:

Bleomycin sulfate
Blenoxane®
BLM

Drug: Vinblastine

6 mg/m^2 IV Over 1 Hour On Day 1 and 15.

Other Name: Velban

Drug: Dacarbazine

375 mg/m^2 IV Over 1 Hour On Day 1 and 15.

Other Names:

DTIC
DTIC-Dome®

Active Comparator: ABVD Therapy

Drug: Adriamycin

25 mg/m^2 IV Over 1 Hour On Day 1 and 15.

Other Names:

Doxorubicin Hydrochloride
Adriamycin PFS®
Adriamycin RDF™

Drug: Bleomycin

10 U/m^2 IV Over 1 Hour On Day 1 and 15.

Other Names:

Bleomycin sulfate
Blenoxane®
BLM

Drug: Vinblastine

6 mg/m^2 IV Over 1 Hour On Day 1 and 15.

Other Name: Velban

Drug: Dacarbazine

375 mg/m^2 IV Over 1 Hour On Day 1 and 15.

Other Names:

DTIC
DTIC-Dome®

Show Detailed Description

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Previously untreated patient with classical Hodgkin's lymphoma patients with stage III and IV.
International Prognostic Score of > 2 (patient must have > 2 of the following risk features: Male, >/= 45 years of age, Stage IV, Albumin <4, WBC >/= 15, Lymphocytes <8% or <600, Hgb <10.5).
Must sign a consent form.
Must be older than 16 years.
Must have adequate bone marrow reserve (ANC >/= 1,500/microL, Platelet > 100,000/microL).
LVEF >/= 50% by MUGA scan or echocardiogram.
Serum creatinine < 2 mg/dl, serum bilirubin < 2 mg/dl, AST or ALT < 2 x ULN.
Bi-dimensionally measurable disease.

Exclusion Criteria:

Lymphocyte Predominant Hodgkin's Lymphoma.
Known HIV infection.
Pregnant women and women of child bearing age who are not practicing adequate contraception.
Prior chemotherapy or radiation therapy.
Severe pulmonary disease as judged by the PI including COPD and asthma.
Active infection requiring treatment with intravenous therapy.
Presence of CNS lymphoma.
Concomitant malignancies or previous malignancies within the last 5 years (exception made for adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of cervix).
Active hepatitis B or C infection.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654732

Contacts

Contact: Anas Younes, MD

713-792-2860

Locations

United States, Florida
University of Miami	Recruiting
Coral Gables, Florida, United States, 33124
United States, Illinois
Rush University	Recruiting
Chicago, Illinois, United States, 60612
United States, New York
Memorial Sloan-Kettering	Recruiting
New York, New York, United States, 10065
United States, Ohio
Cleveland Clinic	Recruiting
Cleveland, Ohio, United States, 44195
United States, Texas
UT MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Anas Younes, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Genentech

Investigators

Principal Investigator:

Anas Younes, MD

M.D. Anderson Cancer Center

More Information

Additional Information:

MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00654732 History of Changes
Other Study ID Numbers:	2007-0144
Study First Received:	April 3, 2008
Last Updated:	September 2, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Hodgkin Lymphoma
Lymphoma
Adriamycin
Doxorubicin Hydrochloride
Adriamycin PFS®
Adriamycin RDF™
Rituxan
Rituximab
Bleomycin
Bleomycin sulfate

Blenoxane®
BLM
Vinblastine
Velban
Dacarbazine
DTIC
DTIC-Dome®
R-ABVD
ABVD

Additional relevant MeSH terms:

Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bleomycin
Doxorubicin
Rituximab
Dacarbazine
Vinblastine
Antibiotics, Antineoplastic

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 09, 2012