Trial record 1 of 1 for:    NCT00654732
Previous Study | Return to List | Next Study

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00654732
First received: April 3, 2008
Last updated: February 28, 2014
Last verified: February 2014
  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 2

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:


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 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  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, 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Genentech
Investigators
Principal Investigator: Michelle Fanale, MD U.T MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00654732     History of Changes
Other Study ID Numbers: 2007-0144, NCI-2010-01501
Study First Received: April 3, 2008
Last Updated: February 28, 2014
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 April 21, 2014