Rituximab and ABVD for Hodgkin's Patients

May 20, 2013 updated by: M.D. Anderson Cancer Center

A Phase II Study of Rituximab + ABVD for Patients With Hodgkin's Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Before treatment starts, patients will have a physical exam. Bone marrow samples will be taken. Blood samples (4 to 8 tablespoons) will be taken before and during the study. A chest x-ray, CT scans of the abdomen and pelvis, and a gallium scan will be done if necessary.

Patients in this study will receive rituximab by vein over 3 to 8 hours weekly for 6 weeks in a row. ABVD will be injected over 3 hours every other week for a total of 12 treatments. On the cycles where both rituximab and ABVD are given, rituximab will be given on day 1, and ABVD will be given on day 2. Response to therapy will be determined after 3 months and at the end of therapy (6 months). At the end, patients may receive radiation therapy to areas of large masses. All treatments can be given in an outpatient setting.

Scans and x-rays will be repeated if needed after completion of therapy and every 3 months from then on. If tumors do not shrink after 3 months of therapy, patients will be offered a different treatment.

This is an investigational study. Although ABVD is considered the standard treatment for patients with Hodgkin's disease, the combination of ABVD with rituximab is considered investigational. All drugs involved in this study are commercially available and are approved by the FDA. Up to 85 patients will take part in this study. All will be enrolled at M. D. Anderson. This protocol is partially funded by a research grant from Genentech.

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • UT MD . Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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.
  2. Must have histologically proven diagnosis of Hodgkin's disease (Nodular sclerosis or mixed cellularity).
  3. Must have bidimensionally measurable disease.
  4. Must sign a consent form.
  5. Must be older than 16 years of age.
  6. Must have adequate bone marrow reserve (ANC > 1,000/microL, Platelet > 100,000/microL
  7. Left Ventricular Ejection Fraction (LVEF) >/= 50% by multigated acquisition (MUGA) scan or echocardiogram.
  8. Serum creatinine < 2 mg/dl, serum bilirubin < 2 mg/dl

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rituximab + ABVD Chemotherapy
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
375 mg/m^2 by vein over 3 to 8 hours weekly for 6 weeks in a row.
Other Names:
  • Rituxan
Drug: Adriamycin
25 mg/m^2 injected by vein over 3 hours every other week for a total of 12 treatments.
Other Names:
  • Rubex
  • Doxorubicin
Drug: Bleomycin
10 U/m^2 injected by vein over 3 hours every other week for a total of 12 treatments.
Other Names:
  • BLM
  • Blenoxane
  • Bleomycin sulfate
Drug: Vinblastine
6 mg/m^2 injected by vein over 3 hours every other week for a total of 12 treatments.
Other Names:
  • Velban
  • Vinblastine Sulfate
Drug: Dacarbazine (DTIC)
375 mg/m^2 injected by vein over 3 hours every other week for a total of 12 treatments.
Other Names:
  • DTIC-Dome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5-year Failure-free Survival Rate for Participants With Hodgkin's Disease Given Rituximab With ABVD
Time Frame: Baseline to 5 Years or until disease progression
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

Genentech, Inc.

Investigators

  • Principal Investigator: Anas Younes, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2001

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

July 19, 2007

First Submitted That Met QC Criteria

July 19, 2007

First Posted (Estimate)

July 20, 2007

Study Record Updates

Last Update Posted (Estimate)

July 9, 2013

Last Update Submitted That Met QC Criteria

May 20, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID00-218

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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