Trial record 1 of 1 for:
NCT00654732
Phase II R-ABVD Versus ABVD for Advanced Stage Classical Hodgkin Lymphoma
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Genentech
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00654732
First received: April 3, 2008
Last updated: May 16, 2013
Last verified: May 2013
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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:
Drug Information available for:
Vinblastine sulfate
Vinblastine
Dacarbazine
Bleomycin sulfate
Bleomycin
Sulfate ion
Doxorubicin
Doxorubicin hydrochloride
Rituximab
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 2015 (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:
Drug: Bleomycin
10 U/m^2 IV Over 1 Hour On Day 1 and 15.
Other Names:
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:
|
|
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:
Drug: Bleomycin
10 U/m^2 IV Over 1 Hour On Day 1 and 15.
Other Names:
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:
|
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 |
| Study First Received: | April 3, 2008 |
| Last Updated: | May 16, 2013 |
| 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 May 23, 2013