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

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ClinicalTrials.gov Identifier: NCT00654732
Recruitment Status : Active, not recruiting
First Posted : April 9, 2008
Last Update Posted : October 6, 2017
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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 or disease Intervention/treatment Phase
Hodgkin Lymphoma Drug: Rituximab Drug: Adriamycin Drug: Bleomycin Drug: Vinblastine Drug: Dacarbazine Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Actual Study Start Date : March 2008
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Number of Patients with Event-Free Survival (EFS) [ Time Frame: Baseline to 3 Years ]
    Efficacy of combination regimen of rituximab and ABVD chemotherapy (R-ABVD) and ABVD alone measured as event-free survival (EFS).



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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, White Blood Count (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 (absolute neutrophil count (ANC) >/= 1,500/microL, Platelet > 100,000/microL).
  • Left ventricular ejection fraction (LVEF) >/= 50% by Multi Gated Acquisition Scan (MUGA) scan or echocardiogram.
  • Serum creatinine < 2 mg/dl, serum bilirubin < 2 mg/dl, aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) < 2 * 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 chronic obstructive pulmonary disease (COPD) and asthma.
  • Active infection requiring treatment with intravenous therapy.
  • Presence of central nervous system (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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00654732


Locations
United States, Florida
University of Miami
Coral Gables, Florida, United States, 33124
United States, Illinois
Rush University
Chicago, Illinois, United States, 60612
United States, New York
Memorial Sloan-Kettering
New York, New York, United States, 10065
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Genentech, Inc.
Investigators
Principal Investigator: Michelle Fanale, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00654732     History of Changes
Other Study ID Numbers: 2007-0144
NCI-2010-01501 ( Registry Identifier: NCI CTRP )
First Posted: April 9, 2008    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Liposomal doxorubicin
Rituximab
Doxorubicin
Bleomycin
Vinblastine
Dacarbazine
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Alkylating
Alkylating Agents