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

Sponsors and Collaborators:	M.D. Anderson Cancer Center Genentech
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00654732

Purpose

Primary Objective:

To evaluate the event free survival (EFS) following therapy with rituximab plus ABVD (Adriamycin {doxorubicin hydrochloride}, Bleomycin, Vinblastine, and Dacarbazine) or standard ABVD in patients with newly diagnosed classical Hodgkin lymphoma who have poor prognosis defined as International prognostic score (IPS) of > 2.

Secondary Objectives:

To compare the effect of the two treatment arms on PET scan results after 2 cycles of therapy.
To compare the effect of the two treatment arms on the level of circulating malignant Hodgkin stem cells.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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 Myocet 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:

To compare the effectiveness of receiving Adriamycin (doxorubicin hydrochloride), bleomycin, vinblastine, and dacarbazine (ABVD) therapy alone to receiving ABVD with rituximab. [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

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
1: Experimental R-ABVD Therapy	Drug: Rituximab 375 mg/m^2 IV Weekly Over 7 Hours On Days 1, 8, 15, 22. Drug: Adriamycin 25 mg/m^2 IV Over 1 Hour On Day 1 and 15. Drug: Bleomycin 10 U/m^2 IV Over 1 Hour On Day 1 and 15. Drug: Vinblastine 6 mg/m^2 IV Over 1 Hour On Day 1 and 15. Drug: Dacarbazine 375 mg/m^2 IV Over 1 Hour On Day 1 and 15.
2: Active Comparator ABVD Therapy	Drug: Adriamycin 25 mg/m^2 IV Over 1 Hour On Day 1 and 15. Drug: Bleomycin 10 U/m^2 IV Over 1 Hour On Day 1 and 15. Drug: Vinblastine 6 mg/m^2 IV Over 1 Hour On Day 1 and 15. Drug: Dacarbazine 375 mg/m^2 IV Over 1 Hour On Day 1 and 15.

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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
U.T.M.D. 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

U.T.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:	U.T.M.D. Anderson Cancer Center ( Anas Younes, MD/Professor )
Study ID Numbers:	2007-0144
Study First Received:	April 3, 2008
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00654732 History of Changes
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

Study placed in the following topic categories:

Immunoproliferative Disorders
Dacarbazine
Immunologic Factors
Hodgkin Lymphoma, Adult
Rituximab
Hodgkin's Disease
Vinblastine
Antimitotic Agents
Bleomycin
Doxorubicin

Lymphatic Diseases
Anti-Bacterial Agents
Tubulin Modulators
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Lymphoproliferative Disorders
Antineoplastic Agents, Phytogenic
Alkylating Agents
Lymphoma
Hodgkin Disease

Additional relevant MeSH terms:

Dacarbazine
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Vinblastine
Antibiotics, Antineoplastic
Therapeutic Uses
Lymphoma
Hodgkin Disease
Alkylating Agents
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases

Rituximab
Mitosis Modulators
Antimitotic Agents
Bleomycin
Doxorubicin
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Tubulin Modulators
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Lymphoproliferative Disorders
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on September 09, 2009