Rituximab and ABVD for Hodgkin's Patients

NCT00504504 | Completed Phase 2 Results

• 1 other identifier: ID00-218
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: \- To determine the feasibility, toxicity, and efficacy of Rituximab with standard dose ABVD combination chemotherapy. ABVD combination chemotherapy consists of Adriamycin, Bleomycin, Vinblastine and DTIC.

Conditions

Lymphoma

Keywords

Hodgkin's Disease; Lymphoma; Rituximab; Rituxan; Adriamycin; Doxorubicin; Rubex; Bleomycin; Bleomycin sulfate; Blenoxane; BLM; Dacarbazine; DTIC; DTIC-Dome; Vincristine; Vinblastine; Vinblastine Sulfate; ABVD; ABVD Chemotherapy Treatment

Outcome Measures

Primary Outcomes (1)

• 5-year Failure-free Survival Rate for Participants With Hodgkin's Disease Given Rituximab With ABVD

  Five year Event Free Survival (EFS) is proportion of surviving participants who remain event free out of total participants at 5 years after receiving Rituximab + ABVD (RABVD). Event-free Survival (EFS) analyzed every 6 months.

  Baseline to 5 Years or until disease progression

Study Arms (1)

Rituximab + ABVD Chemotherapy

EXPERIMENTAL

Rituximab 375 mg/m\^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m\^2 IV, Bleomycin 10 U/m\^2 IV, Vinblastine 6 mg/m\^2 IV, DTIC 375 mg/m\^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.

Drug: Rituximab; Drug: Adriamycin; Drug: Bleomycin; Drug: Vinblastine; Drug: Dacarbazine (DTIC)

Interventions

Rituximab DRUG

375 mg/m\^2 by vein over 3 to 8 hours weekly for 6 weeks in a row.

Also known as: Rituxan

Rituximab + ABVD Chemotherapy

Adriamycin DRUG

25 mg/m\^2 injected by vein over 3 hours every other week for a total of 12 treatments.

Also known as: Doxorubicin, Rubex

Rituximab + ABVD Chemotherapy

Bleomycin DRUG

10 U/m\^2 injected by vein over 3 hours every other week for a total of 12 treatments.

Also known as: Bleomycin sulfate, Blenoxane, BLM

Rituximab + ABVD Chemotherapy

Vinblastine DRUG

6 mg/m\^2 injected by vein over 3 hours every other week for a total of 12 treatments.

Also known as: Vinblastine Sulfate, Velban

Rituximab + ABVD Chemotherapy

Dacarbazine (DTIC) DRUG

375 mg/m\^2 injected by vein over 3 hours every other week for a total of 12 treatments.

Also known as: DTIC-Dome

Rituximab + ABVD Chemotherapy

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Hodgkin's disease patients who relapse after radiation therapy alone and previously untreated patients with stage II bulky, III and IV who are eligible for ABVD.
• Must have histologically proven diagnosis of Hodgkin's disease (Nodular sclerosis or mixed cellularity).
• Must have bidimensionally measurable disease.
• Must sign a consent form.
• Must be older than 16 years of age.
• Must have adequate bone marrow reserve (ANC \> 1,000/microL, Platelet \> 100,000/microL
• Left Ventricular Ejection Fraction (LVEF) \>/= 50% by multigated acquisition (MUGA) scan or echocardiogram.
• Serum creatinine \< 2 mg/dl, serum bilirubin \< 2 mg/dl

You may not qualify if:

• HIV positive.
• Pregnant women and women of child bearing age who are not practicing adequate contraception.
• Prior chemotherapy.
• Severe pulmonary disease including Chronic obstructive pulmonary disease (COPD) and asthma.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Genentech, Inc.: collaborator

Study Sites (1)

UT MD . Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Younes A, Oki Y, McLaughlin P, Copeland AR, Goy A, Pro B, Feng L, Yuan Y, Chuang HH, Macapinlac HA, Hagemeister F, Romaguera J, Samaniego F, Fanale MA, Dabaja BS, Rodriguez MA, Dang N, Kwak LW, Neelapu SS, Fayad LE. Phase 2 study of rituximab plus ABVD in patients with newly diagnosed classical Hodgkin lymphoma. Blood. 2012 May 3;119(18):4123-8. doi: 10.1182/blood-2012-01-405456. Epub 2012 Feb 27.

  PMID: 22371887 RESULT

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease

Interventions

Rituximab; Doxorubicin; Bleomycin; Vinblastine; Dacarbazine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Glycopeptides; Glycoconjugates; Peptides; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Anas Younes, MD / Professor
• Organization: University of Texas (UT) MD Anderson Cancer

CR_Study_Registration@mdanderson.org

Study Officials

• Anas Younes, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2007
• First Posted: July 20, 2007
• Study Start: March 1, 2001
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: July 9, 2013
• Results First Posted: July 9, 2013

Record last verified: 2013-05

Locations

US (1)